5. Ernährungstherapie während Tumortherapie – Klinische Ernährung in der Onkologie

Reference

Level of Evidence

Trial design

Patients n

Patients characteristics

Intervention/methods

Outcome

Results

Campos et al., 1990: Home enteral nutrition via gastrostomy in advanced head and neck cancer patients

III

observational study

39

patients with advanced upper gastrointestinal and head and neck cancer

tube gastrostomies

to assess the efficacy of home feeding by tube gastrostomies as an alternative to an expensive hospitalbased nutritional program

During the 6-month period before gastrostomy insertion, the mean weight loss of the remaining 29 patients was 12.8%, and the mean body weight was less than 90% of ideal body weight. Prior to operation, the mean serum albumin and total lymphocyte count were 3.7 g/L and 1,087/mL, respectively. At discharge the mean caloric intake was 1.48 times resting energy expenditure. Home enteral nutrition was provided for a median of 94 days and resulted in stabilization of nutritional indices. During their median survival of 176 days, the 29 patients were admitted a total of 52 times. Twenty-eight percent of the patients were never re-admitted after gastro-stomy and were adequately maintained at home, whereas 24% needed to be re-admitted once. Only 48% were re-admitted twice to assist in their nutritional management. Twenty patients received temporary home nursing services to aid in their transition. Four patients eventually resumed oral intake, and their Acknowledgment.

Fietkau et al., 1991: Percutaneous endoscopically guided gastrostomy in patients with head and neck cancer

III

obeservational study

212

patients with tumors in the head and neck region

nutritional status prior to, during, and following radiotherapy, was determined by body measurements and biochemical and immunological parameters.

nutritional status and subjective status

The PEG patients had significantly worse initial values in the Padilla quality of life index to assessing the subjective status than the orally fed patients. As with the objective indicators of nutritional status a significant deterioration was seen in the orally fed patients during radiotherapy, while the scores of the PEG patients remained constant.

Tyldesley et al., 1996:

The use of radiologically placed gastrostomy tubes in head and neck cancer patients receiving radiotherapy.

IIa

controlled clinical study

34

Patients undergoing radiotherapy to the head and neck

IG: patients had gastrostomy tubes inserted under radiologic guidance.

(a) patients who had tubes inserted in anticipation of severe reactions

(b) patients who developed severe radiation reactions necessitating nutritional support

CG: matched for age, sex, irradiated volume, and radiation dose, who did not have gastrostomy tubes.

Effect of gastrostomy tubes under radiologic guidance on the restrict oral intake and treatment interruptions.

In both the elective group and the nonelective group, patients maintained their weight at 95 to 97% of the pretreatment weight, at follow-up of 6 weeks and 3 months. This compared with an average weight loss in the control group of 9% at 6 weeks and 12% at 3 months. The length of hospitalization was a mean of 4.9 days in the elective group and 19 days in the nonelective group. Complication were low compared to those documented in the literature, but included two tube migrations, two aspirations, and one gastrointestinal bleed.

Bozzetti et al., 1998: Nutritional support in patients with cancer of the esophagus: impact on nutritional status, patient compliance to therapy, and survival.

III

obeservational study

50

esophageal cancer patients who were to be submitted to chemotherapy  for two cycles plus radiotherapy

Twenty-nine dysphagic patients received nutrition via tube (37 kcal/kg/day + 2.0 g proteins/kg/day for 34 days), while 21 others who were not dysphagic were given a standard oral diet (SD).

analyze the impact of the administration of enteral nutrition (EN) on the patient's nutritional status, tolerance of chemotherapy and radiotherapy, and final oncological outcome.

The dose of administered EN represented 86% of the planned support, and 70% of the nutritional therapy was administered in the home setting. Administration of EN support resulted in stable body weight and unchanged levels of visceral proteins, while SD patients had a decrease in body weight, total proteins and serum albumin (P<0.01). There was no difference between the two groups in terms of tolerance and response to cancer therapy, suitability for radical resection and median survival (9.5 months). EN in patients with cancer of the esophagus undergoing chemotherapy and radiotherapy is well tolerated, feasible even in the home setting, prevents further nutritional deterioration and achieves the same oncological results in dysphagic patients as those achieved in non-dysphagic patients.

Lee et al., 1998: Prophylactic gastrostomy tubes in patients undergoing intensive irradiation for cancer of the head and neck.

IIa

controlled clinical study

88

patients treated for locally advanced head and neck cancer

Patients accelerated twice-a-day radiation (n = 59) or concurrent chemoradiotherapy (n = 29). Prophylactic gastrostomy tubes (PGTs) were placed in 36 (41%) of patients in anticipation of increased acute toxic effects from treatment. The remaining patients without PGTs served as a control group.

effect of PGTs on the rates of weight loss, unplanned interruptions, and hospitalization during high-intensity head and neck radiotherapy

Patients without PGTs lost an average 3.1 kg compared with 7.0 kg in the control group (P<0.001). There were significantly fewer hospitalizations for nutritional or dehydration issues in those with PGTs than in the control group (13% vs 34%; P=0.04, χ2 test). Among those with good performance status, no patient with a PGT required a treatment interruption, compared with 18% of patients without a PGT (P=0.08). Sixteen patients (31%) in the control group underwent therapeutic gastrostomy tube placement during or after radiation therapy. The use of PGTs significantly reduces weight loss and the rate of hospitalization for dehydration and complications of mucositis.

Marcy et al., 2000: Systematic percutaneous fluoroscopic gastrostomy for concomitant radiochemotherapy of advanced head and neck cancer: optimization of therapy.

III

retrospectively observational study

50

patients with advanced head and neck cancer

All patients were managed by percutaneous fluoroscopic gastrostomy (PFG)

describes the results achieved with PFG and its impact on the quality of life in terms of nutritional status

PFG feeding resulted in a mean increase in body weight of 2.5 kg within 3 weeks. Minor complications occurred, but no major complications were noted. The overall procedure-related mortality rate was nil.

Odelli et al., 2005: Nutrition support improves patient outcomes, treatment tolerance and admission characteristics in oesophageal cancer

III

obeservational study

24

Patients with oesophageal cancer undergoing chemoradiation

Patients were assessed as at ‘low’, ‘moderate’ or ‘severe’ nutrition risk, and were provided with appropriate nutrition intervention ranging from preventative advice (low risk), oral nutrition support (moderate risk) to enteral feeding (severe risk).

a nutrition pathway (NP), involving the early then periodic nutrition assessment of all patients presenting to the multidisciplinary oesophageal clinic who were planned to receive definitive chemoradiation

Patients managed using the NP experienced less weight loss (mean weight change -4.2 kg±6.4 cf. - 8.9 kg±5.9, P=0.03), greater radiotherapy completion rates (92% cf. 50%, P=0.001), fewer patients had an unplanned hospital admission (46% cf. 75%, P=0.04), and those that did had a shorter length of stay (3.2 days ± 5.4 cf. 13.5 days ± 14.1, P=0.002).

Paccagnella et al., 2010:

Early nutritional intervention improves treatment tolerance and outcomes in head and neck cancer patients undergoing concurrent chemoradiotherapy

III

retrospective obeservational study

66

Patients with head and neck cancer (HNC)
undergoing chemoradiotherapy

analysed retrospectively the clinical documentation of the HNC patients;

nutrition intervention group, NG: were referred for early nutritional intervention before they were submitted to chemoradiotherapy;

control group, CG: received chemoradio-therapy without receiving a specifically designed early nutrition support programme

the impact of an early intensive nutritional intervention on nutritional status

NG patients lost less weight during chemoradiotherapy compared to CG patients (−4.6±4.1% vs −8.1± 4.8% of pre-treatment weight, p<0.01, at the completion of treatment). Patients in the NG experienced fewer radiotherapy breaks (>5 days) for toxicity (30.3% vs 63.6%, p<0.01); the mean number of days of radiation delayed for toxicity was 4.4±5.2 in NG vs 7.6±6.5 in CG (p<0.05); a linear correlation was found between percentage of weight lost from baseline to chemoradiotherapy completion and days of radiation delays (p<0.01). There were less patients who had an unplanned hospitalisation in the NG relative to the CG (16.1% vs 41.4%, p=0.03). In the NG, symptoms having an effect on the nutritional status developed early and were present in the nearly totality of patients at chemotherapy completion; 60.6% of NG patients needed tube feeding

Mellors et al. (2021): Comparison of prophylactic percutaneous endoscopic gastrostomy with reactive enteral nutrition in patients with head and neck cancer undergoing radiotherapy or chemoradiotherapy: A systematic review

LoE 1

SR:

3 RCT*

(n=298)

Search:

JAN 2015 – MAR 2020

(Additional studies were obtained from reference lists with no date restrictions)

Head-and-neck cancer patients undergoing RT and/or CRT of curative intent with or without other treatment modalities

Age: >18 years

Countries: Sweden (n=134); Australia (n=125);

France (n=39)

Treatment: prophylactic pPEG

Control:

reactive

rEN (PEG or NGT)

Definition in this SR:

prophylactic:

pPEG tube placement and/or feeding commencement that occurs prior to treatment.

Reactive (rEN): feeding tube placement (PEG or NGT) that occurs prior to and/or post-treatment, with feeding commencing when clinically indicated.

1. weight change

2. nutritional status (by SGA & PG-SGA)

3. body mass index (BMI)

4. treatment interruptions

5. quality of life (EORTC-QLQ-C30 and the module for HNC(EORTC-QLQ-H&N35)

6. disease-free survival

7. overall survival

At short-term FU (= 6 months) or long-term FU (>/=12 months

1a. Short-term weight change (n=259, 2 RCT): No difference between groups.

Sub-analysis: When assessing only patients who experienced weight loss, the pPEG group (n=59) lost significantly less weight compared to the rEN group (n=59) (11.4% vs 13.6%, p=0.03) (6-months).

Regarding the percentage (%) of patients that experienced critical weight loss (>10% weight loss), Silander found no significant difference between the pPEG and rEN at 2-months (p=0.059), 3-months (p= 0.27) or 6-months post-treatment (p=0.36).

GRADE: low confidence

1b. Long-term weight change (n=134, 1 RCT): No difference; GRADE: low confidence

2. nutritional status (n=125, 1 RCT):

No significant difference

GRADE: moderate confidence

3. BMI (n=173, 2 RCT):

No difference; GRADE: low confidence

4. treatment interruptions (n=125, 1 RCT): No significant difference; GRADE: moderate confidence

5a. Short term QoL (n=298, 3 RCT):

Statistically significant and clinically important differences favoring the pPEG group were reported by Silander at 2-months for: physical functioning (p=0.01) and constipation (p=0.05) and at 3-months: role functioning (p=0.008); social functioning (p=0.03); appetite loss (p=NR); constipation (p=0.02); diarrhea (p=0.03).

Brown: Clinically important difference for social functioning in the pPEG group (3-months)

At 6-months, significantly higher global health status (EORTC-QLQ-C30) was reported in the pPEG group by Silander (p=0.02) and Salas (p=0.001).

Silander: Further clinically and statistically significant differences in favor of the pPEG group for: physical functioning (p=0.02), cognitive functioning (p=0.008), role functioning (p=0.05), fatigue (p=0.01), dyspnea ( p=D) & feeling ill, coughing, opening the mouth wide and sexuality (EORTC-QLQ-H&N35)

GRADE: moderate confidence

5b. Long term QoL (n=134, 1 RCT):

A statistically significant difference between pPEG and rEN group was reported at 12-months for social functioning (83 versus 75, p=0.03) and dyspnea (12 versus 23, p=0.04).

Furthermore, clinically significant differences on two symptoms scales (ability to open mouth wide and sticky saliva) were found at 24-months in favor of the pPEG group.

GRADE: low confidence

6. disease-free survival (n=125, 1 RCT):

No difference; GRADE: moderate confidence

7. overall survival (n=298, 3 RCT):

No difference; GRADE: moderate confidence

See outcome “4. treatment interruptions” (others were not investigated).

SR:

No funding from agencies in the public, commercial, or not-for-profit sectors.

The authors declare no conflict of interest.

Primary studies:

Not reported in SR

SR quality:

good quality

CONTRA:

Due to significant heterogeneity (time period of using prophylactic or reactive feeding, time between PEG placement and the initiation of feeding etc.), the results have to be interpreted with caution.

Only few studies included

PRO:

Cochrane RoB 2 assessment & GRADE certainty assessment

Protocol registration

Quality primary studies:

The RCT (Sweden) reported in Silander et al. (2012, 2012) & Axelsson et al. (2017) was rated “moderate risk”

The RCT (Australia) reported in Brown et al. (2017) was rated “low risk”.

The RCT (France) reported in Salas et al. (2009) was rated as “high risk”.

Ye & Chang et al. (2021): The effect of timing of enteral nutrition support on feeding outcomes and dysphagia in patients with head and neck cancer undergoing radiotherapy or chemoradiotherapy: A systematic review

Aim: “This systematic review reports the effect of EN timing in patients with HNC undergoing curative-intent and definitive or adjuvant radiotherapy or chemoradiotherapy on tube feeding duration, tube-related complications and dysphagia.”

Author’s conclusion: “Timing of EN (prophylactic vs. reactive) may have little or no effect on tube feeding duration or complications, however, the effect on dysphagia was uncertain. Larger well-designed trials are warranted to increase certainty of evidence regarding EN timing in patients with HNC.”

LoE 1

SR:

2 RCT*

(n=265)

Search:

JAN 2015 – APR 2020

(Additional articles were retrieved from reference lists with no date restrictions)

Head-and-neck cancer patients receiving treatment with curative or definitive or adjuvant radiotherapy or chemoradiotherapy (any tumour stage)

Age: >18 years

Countries: Sweden (n=134); Australia (n=131)

1. Treatment: prophylactic pPEG

2. Control:

reactive rPEG/rNGT

Definition in this SR:

prophylactic: PEG tube (pPEG) inserted prophylactically & EN regimen initiated immediately post-insertion or when oral intake became inadequate & weight loss >1 kg.

reactive: PEG (rPEG) or NG (rNGT) tube inserted either prophylactically but EN regimen initiated only when clinically indicated or inserted reactively for immediate use.

1. tube feeding duration:

Short-term FU (<12 months)

Long term FU (>/=12 months)

2. tube-related complications

3. dysphagia

1. tube feeding duration:

Short-term FU (<12 months):

„Silander et al. found that the mean tube feeding duration from start of tube feeding to removal was significantly longer in the pPEG compared to the rPEG/rNGT group (177 vs. 122 days, p < 0.0001).”

“In contrast, Brown et al. reported no significant difference (115.5 vs. 104.7 days, p=0.333).

GRADE: very low confidence

Long term FU (>/=12 months):

no significant differences between the groups

GRADE: moderate confidence

2. tube-related complications

“No significant difference was found in minor or major tube- related complications among all studies investigated”

GRADE: low confidence

3. dysphagia

“Two different indirect assessment tools were used across the studies and all reported no significant difference in dysphagia between groups.”

GRADE: very low confidence

à “A definitive conclusion could not be reached due to small sample sizes, heterogeneity in the definitions and protocols for prophylactic and reactive EN approaches, variations in timepoints for outcome assessment and indirect dysphagia measures.”

See outcome “tube-related complications” (others were not reported).

SR:

No external funding.

The authors declare no conflict of interest.

Primary studies:

No information about COI in primary studies

SR quality: moderate quality

CONTRA:

Due to significant heterogeneity (time period of using prophylactic or reactive feeding, time between PEG placement and the initiation of feeding etc.), the results have to be interpreted with caution.

PRO:

Cochrane RoB 2 assessment & GRADE certainty assessment

Protocol registration

Quality primary studies:

The RCT (Sweden) reported in Silander et al. (2012, 2012) & Axelsson et al. (2017) was rated “moderate risk”

The RCT (Australia) reported in Brown et al. (2017a, 2017b) was rated “low risk”.

Mellors et al. (2021): Comparison of prophylactic percutaneous endoscopic gastrostomy with reactive enteral nutrition in patients with head and neck cancer undergoing radiotherapy or chemoradiotherapy: A systematic review

Aim: “This review aims to compare the outcomes for patients with HNC undergoing curative intent radiotherapy (RT) or chemoradiotherapy (CRT) receiving either prophylactic percutaneous endoscopic gastrostomy (pPEG) tube placement/feeding or reactive enteral nutrition (rEN).”

Author’s conclusion: “The optimal timing of enteral tube placement and feeding commencement in patients with HNC undergoing RT or CRT remains uncertain. The findings from this review suggest that patients with pPEG are less likely to experience short-term critical weight loss (low certainty) and experience improvements in QoL compared to rEN group at 6-months post-treatment (moderate certainty). Future well-designed trials with consistent definitions of enteral nutritional support, additional measurement time points and validated tools to evaluate patient's nutritional status, are required to strengthen the certainty of evidence regarding the optimal method of nutrition support for patients with HNC.”

LoE 1

SR:

3 RCT*

(n=298)

Search:

JAN 2015 – MAR 2020

(Additional studies were obtained from reference lists with no date restrictions)

Head-and-neck cancer patients undergoing RT and/or CRT of curative intent with or without other treatment modalities

Age: >18 years

Countries: Sweden (n=134); Australia (n=125);

France (n=39)

Treatment: prophylactic pPEG

Control:

reactive

rEN (PEG or NGT)

Definition in this SR:

prophylactic:

pPEG tube placement and/or feeding commencement that occurs prior to treatment.

Reactive (rEN): feeding tube placement (PEG or NGT) that occurs prior to and/or post-treatment, with feeding commencing when clinically indicated.

1. weight change

2. nutritional status (by SGA & PG-SGA)

3. body mass index (BMI)

4. treatment interruptions

5. quality of life (EORTC-QLQ-C30 and the module for HNC(EORTC-QLQ-H&N35)

6. disease-free survival

7. overall survival

At short-term FU (= 6 months) or long-term FU (>/=12 months

1a. Short-term weight change (n=259, 2 RCT): No difference between groups.

Sub-analysis: When assessing only patients who experienced weight loss, the pPEG group (n=59) lost significantly less weight compared to the rEN group (n=59) (11.4% vs 13.6%, p=0.03) (6-months).

Regarding the percentage (%) of patients that experienced critical weight loss (>10% weight loss), Silander found no significant difference between the pPEG and rEN at 2-months (p=0.059), 3-months (p= 0.27) or 6-months post-treatment (p=0.36).

GRADE: low confidence

1b. Long-term weight change (n=134, 1 RCT): No difference; GRADE: low confidence

2. nutritional status (n=125, 1 RCT):

No significant difference

GRADE: moderate confidence

3. BMI (n=173, 2 RCT):

No difference; GRADE: low confidence

4. treatment interruptions (n=125, 1 RCT): No significant difference; GRADE: moderate confidence

5a. Short term QoL (n=298, 3 RCT):

Statistically significant and clinically important differences favoring the pPEG group were reported by Silander at 2-months for: physical functioning (p=0.01) and constipation (p=0.05) and at 3-months: role functioning (p=0.008); social functioning (p=0.03); appetite loss (p=NR); constipation (p=0.02); diarrhea (p=0.03).

Brown: Clinically important difference for social functioning in the pPEG group (3-months)

At 6-months, significantly higher global health status (EORTC-QLQ-C30) was reported in the pPEG group by Silander (p=0.02) and Salas (p=0.001).

Silander: Further clinically and statistically significant differences in favor of the pPEG group for: physical functioning (p=0.02), cognitive functioning (p=0.008), role functioning (p=0.05), fatigue (p=0.01), dyspnea ( p=D) & feeling ill, coughing, opening the mouth wide and sexuality (EORTC-QLQ-H&N35)

GRADE: moderate confidence

5b. Long term QoL (n=134, 1 RCT):

A statistically significant difference between pPEG and rEN group was reported at 12-months for social functioning (83 versus 75, p=0.03) and dyspnea (12 versus 23, p=0.04).

Furthermore, clinically significant differences on two symptoms scales (ability to open mouth wide and sticky saliva) were found at 24-months in favor of the pPEG group.

GRADE: low confidence

6. disease-free survival (n=125, 1 RCT):

No difference; GRADE: moderate confidence

7. overall survival (n=298, 3 RCT):

No difference; GRADE: moderate confidence

See outcome “4. treatment interruptions” (others were not investigated).

SR:

No funding from agencies in the public, commercial, or not-for-profit sectors.

The authors declare no conflict of interest.

Primary studies:

Not reported in SR

SR quality:

good quality

CONTRA:

Due to significant heterogeneity (time period of using prophylactic or reactive feeding, time between PEG placement and the initiation of feeding etc.), the results have to be interpreted with caution.

Only few studies included

PRO:

Cochrane RoB 2 assessment & GRADE certainty assessment

Protocol registration

Quality primary studies:

The RCT (Sweden) reported in Silander et al. (2012, 2012) & Axelsson et al. (2017) was rated “moderate risk”

The RCT (Australia) reported in Brown et al. (2017) was rated “low risk”.

The RCT (France) reported in Salas et al. (2009) was rated as “high risk”.

Ye & Chang et al. (2021): The effect of timing of enteral nutrition support on feeding outcomes and dysphagia in patients with head and neck cancer undergoing radiotherapy or chemoradiotherapy: A systematic review

Aim: “This systematic review reports the effect of EN timing in patients with HNC undergoing curative-intent and definitive or adjuvant radiotherapy or chemoradiotherapy on tube feeding duration, tube-related complications and dysphagia.”

Author’s conclusion: “Timing of EN (prophylactic vs. reactive) may have little or no effect on tube feeding duration or complications, however, the effect on dysphagia was uncertain. Larger well-designed trials are warranted to increase certainty of evidence regarding EN timing in patients with HNC.”

LoE 1

SR:

2 RCT*

(n=265)

Search:

JAN 2015 – APR 2020

(Additional articles were retrieved from reference lists with no date restrictions)

Head-and-neck cancer patients receiving treatment with curative or definitive or adjuvant radiotherapy or chemoradiotherapy (any tumour stage)

Age: >18 years

Countries: Sweden (n=134); Australia (n=131)

1. Treatment: prophylactic pPEG

2. Control:

reactive rPEG/rNGT

Definition in this SR:

prophylactic: PEG tube (pPEG) inserted prophylactically & EN regimen initiated immediately post-insertion or when oral intake became inadequate & weight loss >1 kg.

reactive: PEG (rPEG) or NG (rNGT) tube inserted either prophylactically but EN regimen initiated only when clinically indicated or inserted reactively for immediate use.

1. tube feeding duration:

Short-term FU (<12 months)

Long term FU (>/=12 months)

2. tube-related complications

3. dysphagia

1. tube feeding duration:

Short-term FU (<12 months):

„Silander et al. found that the mean tube feeding duration from start of tube feeding to removal was significantly longer in the pPEG compared to the rPEG/rNGT group (177 vs. 122 days, p < 0.0001).”

“In contrast, Brown et al. reported no significant difference (115.5 vs. 104.7 days, p=0.333).

GRADE: very low confidence

Long term FU (>/=12 months):

no significant differences between the groups

GRADE: moderate confidence

2. tube-related complications

“No significant difference was found in minor or major tube- related complications among all studies investigated”

GRADE: low confidence

3. dysphagia

“Two different indirect assessment tools were used across the studies and all reported no significant difference in dysphagia between groups.”

GRADE: very low confidence

à “A definitive conclusion could not be reached due to small sample sizes, heterogeneity in the definitions and protocols for prophylactic and reactive EN approaches, variations in timepoints for outcome assessment and indirect dysphagia measures.”

See outcome “tube-related complications” (others were not reported).

SR:

No external funding.

The authors declare no conflict of interest.

Primary studies:

No information about COI in primary studies

SR quality: moderate quality

CONTRA:

Due to significant heterogeneity (time period of using prophylactic or reactive feeding, time between PEG placement and the initiation of feeding etc.), the results have to be interpreted with caution.

PRO:

Cochrane RoB 2 assessment & GRADE certainty assessment

Protocol registration

Quality primary studies:

The RCT (Sweden) reported in Silander et al. (2012, 2012) & Axelsson et al. (2017) was rated “moderate risk”

The RCT (Australia) reported in Brown et al. (2017a, 2017b) was rated “low risk”.

Gomes et al. (2015): Percutaneous endoscopic gastrostomy versus nasogastric tube feeding for adults with swallowing disturbances (Review)

Aim: To evaluate the effectiveness and safety of PEG compared with NGT for adults with swallowing disturbances.

Author’s main results & conclusion: The studies showed a higher probability of treatment failure with a nasal gastric tube. The number of deaths was no different with the two methods; nor was the overall occurrence of adverse events. Participants with PEGs may have a better quality of life. PEG was associated with a lower probability of intervention failure, suggesting the endoscopic procedure (PEG) may be more effective and safe compared with NGT. There is no significant difference in mortality rates between comparison groups, or in adverse events, including pneumonia related to aspiration.

LoE 1

SR & MA

SR: 11 RCT

(n=735)

Cancer:

2 RCT (n=142)

Search:

–  JAN 2014

Patients with swallowing disturbances or dysphagia (indications for nutritional support with any underlying diseases)

Age: Adults

Countries:

Australia

Egypt

Greece

India

Japan

Malaysia

Netherlands

UK (4x)

1. Percutaneous endoscopic gastrostomy (PEG)

2. Nasogastric tube (NGT)

Further information:

PEG: Performed by any method (e.g. pull & push methods, others).

NGT: Irrespective of technique (e.g. conventional and looping).

Prim. EP:

1. Intervention failure (e.g. feeding interruption, blocking or leakage of the tube, no adherence to treatment).

Sec. EP:

2. Nutritional status (any validated instrument, such as upper-arm skin fold thickness, mid-arm circumference, body weight, serum albumin level, haemoglobin)

3. Mortality

4. Adverse events (AEs)

(e.g. aspiration, haemorrhage, pneumonia, wound infection, sinusitis, fistula)

5. Time on enteral nutrition

6. Quality of life

(as measured by any validated instrument)

7. Length of hospital stay

8. Costs & economic issues:

1a. Intervention failure (8 RCTs, incl. Corry, Sadavisan):

Fewer participants in the PEG group experienced an intervention failure (risk ratio (RR) 0.18, 95% confidence interval (CI) 0.05 to 0.59, P=0.005; à PEG in favour (also for cancer studies), see Analysis 1.1 below.

1b. Non-adherence to treatment (1 RCT, Sadasivan)

6 weeks: RR 0.02, 95% CI 0.00 to 0.36

6 months: RR 0.01, 95% CI 0.00 to 0.16)

à statistically significantly à PEG in favour (see Analysis 1.2 below)

2. Nutritional status:

a. Weight (3 RCTs, n=148, inkl. Corry, Sadasivan)

weight change from baseline: MD 3.11, 95% CI -0.52 to 6.75

à No significant difference

b. Mid-arm circumference:

2 RCTs, n=54, inkl. Corry): MD 1.58, 95% CI -0.11 to 3.27

No significant difference

2 RCTs, n= 115, inkl. Sadasivan): change from baseline: MD 1.16, 95% CI 1.01 to 1.31. Statistically significant à PEG in favour, see Analysis 1.15 below.

c. Serum albumin:

Sadasivan (n= 94): change in albumin levels from baseline: MD 0.12, 95% CI 0.11 to 0.14 à statistically significant à PEG in favour, see Analysis 1.17 below.

d. Haemoglobin (1 RCT, n=94, Sadasivian):

Change from baseline: MD 0.59, 95% CI 0.49 to 0.69 —> statistically significant à PEG in favour, see Analysis 1.18 below.

3. Mortality (9 RCTs, n=644, incl. Corry): No significant difference

5. Time on enteral nutrition (2 RCTs, n=119): No significant difference

6. QoL: (2 RCTs, Corry, Sadavisan with EORTC QLQ-H&N35 scale):

inconvenience (RR 0.03, 95% CI 0.00 to 0.29; P=0.002)

discomfort (RR 0.03, 95% CI 0.00 to 0.29; P=0.002)

altered body image (RR 0.01, 95% CI 0.00 to 0.18; P=0.001)

social activities (RR 0.01, 95% CI 0.00 to 0.18; n= 100, P=0.001), in favour of PEG see Analysis 1.22 below.

Pain & ease of learning à No statistically significant difference

7. Length of hospital stay (2 RCTs, n= 381). No significant difference

8. Costs & economic issues:

Corry 2008: „cost of each feeding tube is $26 for a NGT and $110 for a PEG tube" and "The insertion costs are significantly different as the NGT are inserted by nursing staff in outpatients and the PEG tubes are inserted by surgeons in theatre. The cost for insertion of a NGT is $50 (includes nursing time and cost of chest X-ray), whereas the cost of insertion of a PEG tube is $626".

4. AEs (6 RCTs, incl. Corry, Sadavisan, n=597):

No statistically significant difference between groups (high levels of statistical heterogeneity I²=87%)

Pneumonia

(7 RCTs, incl. Corry, n=645)

PEG: 31.93% (106 out of 332)

NGT: 41.54% (130 out of 313)

(RR 0.70, 95% CI 0.46 to 1.06) —> no significant difference

Reflux oesophagitis:

Douzinas 2006: less severe reflux was seen in the PEG group (statistically significant)

Yata 2001: RR 0.45, 95% CI 0.22 to 0.92. statistically significant result that favoured the PEG group.

à PEG in favour

SR:

Funding: CAPES - Ministry of Education for the postgraduate scholarship (Brazil)

COI: Authors declare no conflict of interest.

Primary studies:

No information about COI in primary studies

SR quality:

high quality

CONTRA:

Mainly indirect evidence (different conditions, only 2 cancer studies (n=142)

High heterogeneity in most analysis

PRO:

Cochrane RoB 2 assessment & GRADE certainty assessment

Authors obtained further information from the study investigators (e.g. Bath 2009; Corry 2008b)

Protocol registration

Quality primary studies:

RoB: All studies have a high risk of bias, because intervention cannot be blinded. 

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 11: Eine postoperative parenterale Ernährung mit Supplementierung von Omega-3-Fettsäuren sollte bei Patienten eingesetzt werden, die enteral nicht ausreichend ernährt werden können und daher eine überwiegend parenteral oder kombiniert enteral/parenterale Ernährung benötigen. (BM, HE) (modifiziert, Stand 2022)

Empfehlungsgrad B, Starker Konsens 100 % Zustimmung

Kapitel 3.4, S. 252

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Klinische Ernährung in der Chirurgie der Deutschen Gesellschaft für Ernährungsmedizin (DGEM) e. V.

Version 3.0, Stand: 31.10.2022; https://register.awmf.org/de/leitlinien/detail/073-005

Aktuelle Ernährungsmedizin 2023; 48(04): 237-290; DOI: 10.1055/a-2104-9792

https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2104-9792

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 77%

Domäne 6: 86%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Die Leitlinie gibt die PICO-Fragestellung in Form einer Schlüsselfrage an:

Gibt es eine Indikation für eine parenterale Supplementierung mit Omega-3-Fettsäuren?

Datum der Recherche

01.01.2016 - 27.12.2020

Anzahl der Studien, Studientyp, Referenzierung

7 Studien: 7 SR/MA

• 7 Systematische Reviews mit Meta-Analyse:
• Lu S, Yang Z, Tang H, Sun X, Wang B, Qu J, et al. Associations between omega-3 polyunsaturated fatty acids supplementation and surgical prognosis in patients with gastrointestinal cancer: A systematic review and meta-analysis. Food Chem (Oxf). 2022;4:100099. (MA, LoE 1++)
• Pradelli L, Mayer K, Klek S et al. omega-3 Fatty-Acid Enriched Parenteral Nutrition in Hospitalized Patients: Systematic Review With Meta-Analysis and Trial Sequential Analysis. JPEN J Parenter Enteral Nutr 2020; 44: 44-57. doi:10.1002/jpen.1672 (MA, LoE 1++)
• Mocellin MC, Fernandes R, Chagas TR et al. A meta-analysis of n-3 polyunsaturated fatty acids effects on circulating acute-phase protein and cytokines in gastric cancer. Clin Nutr 2018; 37: 840-850. doi:10.1016/j.clnu.2017.05.008 (MA, LoE 1++)
• Li NN, Zhou Y, Quin XP, Chen Y, He D, Feng JY, Wu XT Does intravenous fish oil benefit patients post-surgery? A meta-analysis of randomised controlled trials. Clin Nutr 2014; 33: 226–239. (MA, LoE 1++)
• Tian H, Yao X, Zeng R, Sun R, Tian H, Shi C, Li L, Tian J, Yang K Safety and efficacy of a new parenteral lipid emulsion (SMOF) for surgical patients: a systematic review and meta-analysis of randomized controlled trials. Nutr.Rev.2013; 71: 815–821. (MA, LoE 1+)
• Pradelli L, Mayer K, Muscaritoli M, Heller AR n-3 fatty acid-enriched parenteral nutrition regimens in elective surgical and ICU patients: a meta-analysis. Crit.Care 2012; 16): R184. (MA, LoE 1++)
• Chen B, Zhou Y, Yang P, Wan HW, Wu XT Safety and efficacy of fish oil-enriched parenteral nutrition regimen on postoperative patients undergoing major abdominal surgery: a meta-analysis of randomized controlled trials. JPEN J Parenter Enteral Nutr 2010; 34:387-394. (MA, LoE 1++)

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

Zusätzliches Material 1: Evidenztabellen

https://www.thieme-connect.de/media/akternmed/202304/supmat/10-1055-a-2104-9792-21049792-0001.pdf

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

Graduierung in der adaptierten Leitlinie nach SIGN (2014), siehe oben LoE zu jeder Studie

--> Level of Evidence nach Oxford 2011 neu eingeschätzt: LoE 1

Ggfs. Interpretation der Evidenz/ Evidence to decision

NA

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

☒ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Eventuell redaktionelle Änderungen.

Wortlaut der Empfehlung: Eine postoperative parenterale Ernährung angereichert mit Omega-3-Fettsäuren sollte bei Patienten eingesetzt werden, die enteral nicht ausreichend ernährt werden können und daher eine überwiegend parenteral oder kombiniert enteral/parenterale Ernährung benötigen.

☐adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

Begründung für Modifikation

Entsprechend der Diskussion in der Expertengruppe im AG-Treffen am 02.09.2024

Wortlaut der Empfehlung:

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen.

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 12: Patienten, die sich einer größeren Tumoroperation unterziehen, kann präoperativ oder perioperativ eine Immunonutrition (angereichert mit Arginin, Omega-3-Fettsäuren, Ribonukleotiden) angeboten werden. (BM, HE) (modifiziert, Stand 2022)

Empfehlungsgrad 0, Starker Konsens 91 % Zustimmung

Kapitel 3.5, S. 252

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Klinische Ernährung in der Chirurgie der Deutschen Gesellschaft für Ernährungsmedizin (DGEM) e. V.

Version 3.0, Stand: 31.10.2022; https://register.awmf.org/de/leitlinien/detail/073-005

Aktuelle Ernährungsmedizin 2023; 48(04): 237-290; DOI: 10.1055/a-2104-9792

https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2104-9792

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 77%
Domäne 6: 86%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Die Leitlinie gibt die PICO-Fragestellung in Form einer Schlüsselfrage an:

Gibt es eine Indikation für eine bestimmte orale/ enterale Formel, die mit unterschiedlichen, immunologisch wirksamen Nährstoffkombinationen (Immunonutrition) angereichert ist?

Datum der Recherche

01.01.2016 - 27.12.2020

Anzahl der Studien, Studientyp, Referenzierung

37 Studien: 1 Umbrella-Review; 32 MA/3SR

• 1 Umbrella-Review:
• Slim K, Badon F, Vacheron CH et al. Umbrella review of the efficacy of perioperative immunonutrition in visceral surgery. Clin Nutr ESPEN 2022; 48: 99–108. DOI: 10.1016/j.clnesp.2022.02.015

• 32 Systematische Reviews mit Meta-Analyse:
• Matsui R, Sagawa M, Sano A, Sakai M, Hiraoka SI, Tabei I, Imai T, Matsumoto H, Onogawa S, Sonoi N, Nagata S, Ogawa R, Wakiyama S, Miyazaki Y, Kumagai K, Tsutsumi R, Okabayashi T, Uneno Y, Higashibeppu N, Kotani J. Impact of Perioperative Immunonutrition on Postoperative Outcomes for Patients Undergoing Head and Neck or Gastrointestinal Cancer Surgeries: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Ann Surg. 2024 Mar 1;279(3):419-428. doi: 10.1097/SLA.0000000000006116. Epub 2023 Oct 26. PMID: 37882375; PMCID: PMC10829905.
• Khan A, Wong J, Riedel B, Laing E, Beaumont A, Kong J, Warrier S, Heriot A. The Impact of Peri-operative Enteral Immunonutrition on Post-operative Complications in Gastrointestinal Cancer Surgery: A Meta-Analysis. Ann Surg Oncol. 2023 Jun;30(6):3619-3631. doi: 10.1245/s10434-023-13265-1. Epub 2023 Feb 23. PMID: 36820938.
• Shen J, Dai S, Li Z, Dai W, Hong J, Huang J, et al. Effect of Enteral Immunonutrition in Patients Undergoing Surgery for Gastrointestinal Cancer: An Updated Systematic Review and Meta-Analysis. Front Nutr. 2022;9:941975. (MA, LoE 1++)
• Dushianthan A, Cusack R, Burgess VA et al. Immunonutrition for Adults With ARDS: Results From a Cochrane Systematic Review and Meta-Analysis. Respir Care 2020; 65: 99-110. doi:10.4187/respcare.06965 (MA, LoE 1++)
• Yu K, Zheng X, Wang G et al. Immunonutrition vs Standard Nutrition for Cancer Patients: A Systematic Review and Meta-Analysis (Part 1). JPEN J Parenter Enteral Nutr 2020; 44: 742-767. doi:10.1002/jpen.1736 (MA, LoE 1++)
• Mingliang W, Zhangyan K, Fangfang F et al. Perioperative immunonutrition in esophageal cancer patients undergoing esophagectomy: the first meta-analysis of randomized clinical trials. Dis Esophagus 2020; 33. doi:10.1093/dote/doz111 (MA, LoE 1++)
• Zhang X, Chen X, Yang J et al. Effects of nutritional support on the clinical outcomes of well-nourished patients with cancer: a meta-analysis. Eur J Clin Nutr 2020; 74: 1389-1400. doi:10.1038/s41430-020-0595-6 (MA, LoE 1++)
• Li XK, Zhou H, Xu Y et al. Enteral immunonutrition versus enteral nutrition for patients undergoing oesophagectomy: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg 2020; 30: 854-862. doi:10.1093/icvts/ivaa022 (MA, LoE 1+)
• Yang FA, Chen YC, Tiong C. Immunonutrition in Patients with Pancreatic Cancer Undergoing Surgical Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients 2020; 12: 2798. doi:10.3390/nu12092798 (MA, LoE 1++)
• Wong CS, Praseedom R, Liau SS. Perioperative immunonutrition in hepatectomy: A systematic review and meta-analysis. Ann Hepatobiliary Pancreat Surg 2020; 24: 396-414. doi:10.14701/ahbps.2020.24.4.396 (MA, LoE 1++)
• Gao B, Luo J, Liu Y et al. Clinical Efficacy of Perioperative Immunonutrition Containing Omega-3-Fatty Acids in Patients Undergoing Hepatectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab 2020; 76: 375-386. doi:10.1159/000509979 (MA, LoE 1++)
• Guan H, Chen S, Huang Q. Effects of Enteral Immunonutrition in Patients Undergoing Pancreaticoduodenectomy: A Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab 2019; 74: 53-61. doi:10.1159/000495468 (MA, LoE 1+)
• Zhang B, Najarali Z, Ruo L et al. Effect of Perioperative Nutritional Supplementation on Postoperative Complications—Systematic Review and Meta-Analysis. J Gastrointest Surg 2019. 1-12 (MA, LoE 1++)
• Adiamah A, Skorepa P, Weimann A et al. The Impact of Preoperative Immune Modulating Nutrition on Outcomes in Patients Undergoing Surgery for Gastrointestinal Cancer: A Systematic Review and Meta-analysis. Ann Surg 2019; 270: 247-256. doi:10.1097/SLA.0000000000003256 (MA, LoE 1++)
• Cheng Y, Zhang J, Zhang L et al. Enteral immunonutrition versus enteral nutrition for gastric cancer patients undergoing a total gastrectomy: a systematic review and meta-analysis. BMC Gastroenterol 2018; 18: 11. doi:10.1186/s12876-018-0741-y (MA, LoE 1++)
• Zhang C, Chen B, Jiao A et al. The benefit of immunonutrition in patients undergoing hepatectomy: a systematic review and meta-analysis. Oncotarget 2017; 8: 86843- 86852. doi:10.18632/oncotarget.20045 (MA, LoE 1+)
• Song GM, Liu XL, Bian W et al. Systematic review with network meta-analysis: comparative efficacy of different enteral immunonutrition formulas in patients underwent gastrectomy. Oncotarget 2017; 8: 23376-23388. doi:10.18632/oncotarget.15580 (NMA, LoE 1-)
• Hegazi RA, Hustead DS, Evans DC Preoperative standard oral nutrition supplements vs immunonutrition: Results of a systematic review and meta-analysis. J Am Coll Surg; 2016; 219:1078-1087. (MA, LoE 1++)
• Wong CS, Aly EH The effects of enteral immunonutrition in upper gastrointestinal surgery: a systematic review and meta-analysis. Int J Surg 2016; 29: 137-150. (MA, LoE 1++)
• Song GM, Tan X, Liang H, Yi LJ, Zhou JG. Zeng Z, Shuai T, Ou YX, Zhang L, Wang Y. Role of Enteral Immunonutrition in Patients Undergoing Surgery for Gastric Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicine (Baltimore) 2015; 94: e1311 (MA, LoE 1++)
• Song GM, Tian X, Zhang L, Ou YX, Yi LJ, Shuai T, Zhou JG, Zeng Z, Yang HL Immunonutrition Support for Patients Undergoing Surgery for Gastrointestinal Malignancy: Preoperative, Postoperative, or Perioperative? A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Medicine (Baltimore) 94(29): e1225 (MA, LoE 1++)
• Marimuthu K, Varadhan KK, Ljungqvist O, Lobo DN A meta-analysis of the effect of combinations of immune modulating nutrients on outcome in patients undergoing major open gastrointestinal surgery. Ann Surg 2012; 255:1060-1068. (MA, LoE 1++)
• Osland E, Hossain MB, Khan S, Memon MA Effect of Timing of Pharmaconutrition (Immunonutrition) Administration on Outcomes of Elective Surgery for Gastrointestinal Malignancies: A Systematic Review and Meta-Analysis. JPEN J Parenter Enteral Nutr 38: 53-69.
• Zhang Y, Gu Y, Guo T, Li Y, Ca H Perioperative immunonutrition for gastrointestinal cancer: A systematic review of randomized controlled trials. Surg Oncol 2012; 21: e87- e95 (MA, LoE 1++)
• Cerantola Y, Hubner M, Grass F, Demartines N, Schafer M Immunonutrition in gastrointestinal surgery. Br J Surg 2011; 98:37-48. (MA, LoE 1++)
• Drover JW, Dhaliwal R, Weitzel L, Wischmeyer PE, Ochoa JB, Heyland DK Perioperative use of arginine-supplemented diets: a systematic review of the evidence. J Am Coll Surg 2011; 212:385-99, 399.e1. (MA, LoE 1++)
• Montejo JC, Zarazaga A, Lopez-Martinez J, Urrutia G, Roque M, Blesa AL, Celaya S, Conejero R, Galban C, Garcia de Lorenzo A, Grau T, Mesejo A, Ortiz-Leyba C, Planas M, Ordonez J, Jimenez FJ, Spanish Society of Intensive Care Medicine and Coronary Units Immunonutrition in the intensive care unit. A systematic review and consensus statement. Clin Nutr 2003; 22:221-233. (MA, LoE 1++)
• Wilhelm SM, Kale-Pradhan PB Combination of arginine and omega-3 fatty acids enteral nutrition in critically ill and surgical patients: a meta-analysis. Expert Rev Clin Pharmacol 2010; 3:459-469. (MA, LoE 1++)
• Marik PE, Zaloga GP Immunonutrition in high-risk surgical patients: a systematic review and analysis of the literature. JPEN J Parenter Enteral Nutr 2010; 34:378-386. (MA, LoE 1++)
• Waitzberg DL, Saito H, Plank LD, Jamison GG, Jagannath P, Hwang TL, Mijares JM, Bihari D Postsurgical infections are reduced with specialized nutritional support. World J Surg; 2006; 30: 1592-1604. (MA, LoE 1++)
• Beale RJ, Bryg DJ, Bihari DJ Immunonutrition in the critically ill: a systematic review of clinical outcome. Crit Care Med1999; 27:2799-2805. (MA, LoE 1++)
• Heys SD, Walker LG, Smith I, Eremin O Enteral nutritional supplementation with key nutrients in patients with critical illness and cancer: a meta-analysis of randomized controlled clinical trials. Ann Surg 1999; 229:467-477. (MA, LoE 1++)

•  3 Systematische Reviews:
• Howes N, Lewis SJ, Thomas S. Immunonutrition for patients undergoing surgery for head and neck cancer. Cochrane Database Syst Rev 2014. doi:10.1002/14651858.Cd010954. doi:10.1002/14651858.Cd010954 (SR, LoE 1+)
• Stableforth WD, Thomas S, Lewis SJ A systematic review of the role of immunonutrition in patients undergoing surgery for head and neck cancer. Int J Oral Maxillofac Surg 2009; 38:103-110. (SR, LoE 1++)
• Heyland DK, Novak F, Drover JW, Jain M, Su X, Suchner U Should immunonutrition become routine in critically ill patients? A systematic review of the evidence. JAMA 2001; 286:944-953. (SR, LoE 1++)

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

Zusätzliches Material 1: Evidenztabellen

https://www.thieme-connect.de/media/akternmed/202304/supmat/10-1055-a-2104-9792-21049792-0001.pdf 

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

Graduierung in der adaptierten Leitlinie nach SIGN (2014), siehe oben LoE zu jeder Studie

--> Level of Evidence nach Oxford 2011 neu eingeschätzt: LoE 1

Ggfs. Interpretation der Evidenz/ Evidence to decision

NA

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

☒ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Eventuell redaktionelle Änderungen.

Wortlaut der Empfehlung: Patienten, die sich einer größeren Tumoroperation unterziehen, kann präoperativ oder perioperativ eine Immunonutrition (angereichert mit Arginin, Omega-3-Fettsäuren, Ribonukleotiden) angeboten werden.

☐ adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

NA

Begründung für Modifikation

NA

Wortlaut der Empfehlung:

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen.

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 4.8: Die Empfehlung zur Erhaltung und Verbesserung körperlicher Aktivität, ausgewogener Ernährung und Nikotin-/Alkoholverzicht vor einer Tumoroperation ist als internationaler Standard anzusehen. Auf eine darüber hinausgehende intensivierte ressourcenaufwändige Prähabilitation mit strukturierten Programmen kann verzichtet werden. (2023)

Empfehlungsgrad 0, Konsens

Kapitel 4.3, S. 34

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Perioperatives Management bei gastrointestinalen Tumoren (POMGAT), Version 1.0 – November 2023

https://www.leitlinienprogramm-onkologie.de/leitlinien/perioperatives-management-bei-gastrointestinalen-tumoren-pomgat 

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 95%
Domäne 6: 93%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Tabelle 2: Einschlusskriterien für die Literaturauswahl nach dem PICO-Schema

Patient bzw. Problem: Patient mit tumorbedingter gastrointestinaler Operation. Bei einigen Fragen wurde nur eine Subgruppe (z. B. nur ein bestimmtes Operationsspektrum) berücksichtigt.

Intervention: Definition der untersuchten perioperativen Maßnahme

Comparison: Defintion der Kontrollgruppe

Outcomes Die Berichterstattung über bestimmte Outcomes war kein Einschlusskriterium. Studien wurden auch dann eingeschlossen, wenn keines der vordefinierten, zu untersuchenden Outcomes berichtet wurde.

Study type: RCTs und systematische Reviews mit Meta-Analysen von RCTs wurden berücksichtigt. Meta-Analysen, die RCTs und Nicht-RCTS enthalten, waren ebenfalls zulässig, wenn eine Subgruppenanalyse nur mit RCTs berechnet wurde.

Datum der Recherche

Nicht gefunden

Anzahl der Studien, Studientyp, Referenzierung

11 Studien: 1 Umbrella Review; 4 SR/MA; 6 RCT

• 1 Umbrella Review:
• McIsaac D, Gill M, Boland L, Hutton B, Branje K, Shaw J, et al. Prehabilitation in adult patients undergoing surgery: an umbrella review of systematic reviews. Br J Anaesth. 2022;128(2):244- 257. URL: https://pubmed.ncbi.nlm.nih.gov/34922735/

• 4 Systematisches Review/Meta-Analyse:
• Molenaar C, van Rooijen S, Fokkenrood H, Roumen R, Janssen L, Slooter G. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022;5:CD013259. URL: https://pubmed.ncbi.nlm.nih.gov/35588252/  

• Daniels S, Lee M, George J, Kerr K, Moug S, Wilson T, et al. Prehabilitation in elective abdominal cancer surgery in older patients: systematic review and meta-analysis. BJS Open. 2020;: URL: https://pubmed.ncbi.nlm.nih.gov/32959532/
• Lambert J, Hayes L, Keegan T, Subar D, Gaffney C. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA- Accordant Meta-analysis. Ann Surg. 2021;274(1):70-77. URL: https://pubmed.ncbi.nlm.nih.gov/33201129/ 

• Waterland J, McCourt O, Edbrooke L, Granger C, Ismail H, Riedel B, et al. Efficacy of Prehabilitation Including Exercise on Postoperative Outcomes Following Abdominal Cancer Surgery: A Systematic Review and Meta-Analysis. Front Surg. 2021;8:628848. URL: https://pubmed.ncbi.nlm.nih.gov/33816546/

• 6 RCT:
• Berkel A, Bongers B, Kotte H, Weltevreden P, de Jongh F, Eijsvogel M, et al. Effects of Community-based Exercise Prehabilitation for Patients Scheduled for Colorectal Surgery With High Risk for Postoperative Complications: Results of a Randomized Clinical Trial. Ann Surg. 2022;275(2):e299-e306. URL: https://pubmed.ncbi.nlm.nih.gov/33443905/ 
• Fulop A, Lakatos L, Susztak N, Szijarto A, Banky B. The effect of trimodal prehabilitation on the physical and psychological health of patients undergoing colorectal surgery: a randomized clinical trial. Anaesthesia. 2021;76(1):82-90. URL: https://pubmed.ncbi.nlm.nih.gov/32761611/
• Liu K, Ji S, Xu Y, Diao Q, Shao C, Luo J, et al. Safety, feasibility, and effect of an enhanced nutritional support pathway including extended preoperative and home enteral nutrition in patients undergoing enhanced recovery after esophagectomy: a pilot randomized clinical trial. Dis Esophagus. 2020;33(2): URL: https://pubmed.ncbi.nlm.nih.gov/31329828/ 

• Peng L, Wang W, Chen J, Jin J, Min S, Qin P. Implementation of the pre-operative rehabilitation recovery protocol and its effect on the quality of recovery after colorectal surgeries. Chin Med J (Engl). 2021;134(23):2865-2873. URL: https://pubmed.ncbi.nlm.nih.gov/34732661/ 

• Steffens D, Young J, Beckenkamp P, Ratcliffe J, Rubie F, Ansari N, et al. Feasibility and acceptability of a preoperative exercise program for patients undergoing major cancer surgery: results from a pilot randomized controlled trial. Pilot Feasibility Stud. 2021;7(1):27. URL: https://pubmed.ncbi.nlm.nih.gov/33441181/ 

• Waller E, Sutton P, Rahman S, Allen J, Saxton J, Aziz O. Prehabilitation with wearables versus standard of care before major abdominal cancer surgery: a randomised controlled pilot study (trial registration: NCT04047524). Surg Endosc. 2022;36(2):1008-1017. URL: https://pubmed.ncbi.nlm.nih.gov/33723969/

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

LL-POMGAT_Evidenzbericht 1.0:

https://www.leitlinienprogramm-onkologie.de/fileadmin/user_upload/Downloads/Leitlinien/POMGAT/Version_1/LL_POMGAT_Evidenzbericht_1.0.pdf 

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

⊕⊕⊕⊝: Mortalität: Kein Effekt (OR 1,04; 95% KI 0,51 bis 2,12)
⊕⊕⊝⊝: Komplikationsrate (global): Kein Effekt (OR 0,79; 95% KI 0,60 bis 1,02)
⊕⊕⊕⊝: Komplikationsrate (pulmonal): Fragliche Reduktion (OR 0,59; 95% KI 0,33 bis 1,06)

⊕⊕⊝⊝: Komplikationen (Clavien-Dindo > 2): Kein Effekt (OR 0,79; 95% KI 0,44 bis 1,40)

⊕⊕⊝⊝: Krankenhausverweildauer: Kein Effekt (MD -0,07 Tage; 95% KI -0,57 bis 0,44)

⊕⊕⊕⊝: Verweildauer auf Intensivstation: Kein Effekt (MD -0,02; 95% KI -0,54 bis 0,49)

⊕⊕⊕⊝: Gangausdauer: Verbesserung der Gangausdauer (MD 36,08 m; 95% KI 20,95 bis 51,20)
⊕⊕⊝⊝: Lebensqualität: Kein Effekt (SMD 0,34; 95% KI -0,54 bis 1,21)
⊕⊕⊝⊝: Depression Kein Effekt (MD 0,22 HADS-Punkte; 95% KI -1,41 bis 1,85)
⊕⊕⊝⊝: Krankenhausbedingte Angst: Kein Effekt (MD -0,15 HADS-Punkte; 95% KI -0,97 bis 0,67)

Ggfs. Interpretation der Evidenz/ Evidence to decision

s.o. GRADE

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

☒ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Eventuell redaktionelle Änderungen.

Wortlaut der Empfehlung: Die Empfehlung zur Erhaltung und Verbesserung körperlicher Aktivität, ausgewogener Ernährung und Nikotin-/Alkoholverzicht vor einer Tumoroperation ist als internationaler Standard anzusehen. Auf eine darüber hinausgehende intensivierte ressourcenaufwändige Prähabilitation mit strukturierten Programmen kann verzichtet werden.

☐ adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

NA

Begründung für Modifikation

NA

Wortlaut der Empfehlung:

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen.

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 13: Patienten mit hohem metabolischem Risiko sollen eine Ernährungstherapie präoperativ erhalten (A) sogar, wenn dadurch die Operation verschoben wird (BM). (modifiziert, Stand 2022)

Ein Zeitraum von 10 - 14 Tagen kann empfohlen werden (0) 

Empfehlungsgrad A/0, Starker Konsens 92 % Zustimmung

Kapitel 4.1, S. 256

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Klinische Ernährung in der Chirurgie der Deutschen Gesellschaft für Ernährungsmedizin (DGEM) e. V.

Version 3.0, Stand: 31.10.2022; https://register.awmf.org/de/leitlinien/detail/073-005

Aktuelle Ernährungsmedizin 2023; 48(04): 237-290; DOI: 10.1055/a-2104-9792

https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2104-9792

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 77%
Domäne 6: 86%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Die Leitlinie gibt die PICO-Fragestellung in Form einer Schlüsselfrage an:

Welche Patienten profitieren von einer präoperativen Ernährungstherapie?

Datum der Recherche

01.01.2016 - 27.12.2020

Anzahl der Studien, Studientyp, Referenzierung

7 Studien: 3 SR; 5 RCT

• 3 Systematic Review:
• Sowerbutts AM, Burden S, Sremanakova J, French C, Knight SR, Harrison EM. Preoperative nutrition therapy in people undergoing gastrointestinal surgery. Cochrane Database of Systematic Reviews 2024; 4: CD008879.
• Burden S, Todd C, Hill J, Lal S Pre-operative nutrition support in patients undergoing gastrointestinal surgery. Cochrane Database Syst Rev 2012; 11:CD008879. (Review, LoE 1+)
• Heyland DK, Montalvo M, MacDonald S et al.Totalparenteral nutrition in the surgical patient: a meta-analysis. Can J Surg 2001; 44: 102–111

• 5 RCT:
• Wada N, Kurokawa Y, Tanaka K et al. Perioperative Nutritional Support With Beta-hydroxy-beta-methylbutyrate, Arginine, and Glutamine in Surgery for Abdominal Malignancies. Wounds : a compendium of clinical research and practice 2018; 30: 251-256 (RCT, LoE 1-)
• Fukuda Y, Yamamoto K, Hirao M et al. Prevalence of Malnutrition Among Gastric Cancer Patients Undergoing Gastrectomy and Optimal Preoperative Nutritional Support for Preventing Surgical Site Infections. Ann Surg Oncol 2015; 22: S778–785. DOI. DOI: 10.1245/ s10434-015-4820-9
• Bozzetti F, Gavazzi C, Miceli R, Rossi N, Mariani L, Cozzaglio L, Bonfanti G, Piacenza S Perioperative total parenteral nutrition in malnourished, gastrointestinal cancer patients: a randomized, clinical trial. JPEN J Parenter Enteral Nutr 2000; 24:7-14. (RCT, LoE 1+)
• Von Meyenfeldt MF, Meijerink WJ, Rouflart MM, Builmaassen MT, Soeters PB Perioperative nutritional support: a randomised clinical trial. Clin Nutr 1992; 11:180-186. (RCT, LoE 1+)
• Veteran Affairs Perioperative total parenteral nutrition in surgical patients. The Veterans Affairs Total Parenteral Nutrition Cooperative Study Group. N Engl J Med 1991; 325:525-532. (RCT, LoE 1+)

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

Zusätzliches Material 1: Evidenztabellen

https://www.thieme-connect.de/media/akternmed/202304/supmat/10-1055-a-2104-9792-21049792-0001.pdf

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

Graduierung in der adaptierten Leitlinie nach SIGN (2014), siehe oben LoE zu jeder Studie

--> Level of Evidence nach Oxford 2011 neu eingeschätzt: LoE 1-2

Ggfs. Interpretation der Evidenz/ Evidence to decision

NA

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

 ☒ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Redaktionelle Änderung zweiter Satz (entsprechend der Diskussion in der Expertengruppe im AG-Treffen am 02.09.2024).

Wortlaut der Empfehlung: Patienten mit hohem metabolischem Risiko sollen eine Ernährungstherapie präoperativ erhalten, selbst wenn dadurch die Operation verschoben wird.

Eine Verschiebung der Operation um 10-14 Tage bedeutet onkologisch keinen Nachteil.

☐ adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

Begründung für Modifikation

Wortlaut der Empfehlung:

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen.

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 15: Bei Patienten mit Mangelernährung und/oder hohem metabolischen Risiko soll vor großen abdominellen Eingriffen eine Trinknahrung (Oral Nutritional Supplement verabreicht werden. (BM, HE) (modifiziert, Stand 2022)

Empfehlungsgrad A, Starker Konsens 100 % Zustimmung

Kapitel 4.2, S. 257

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Klinische Ernährung in der Chirurgie der Deutschen Gesellschaft für Ernährungsmedizin (DGEM) e. V.

Version 3.0, Stand: 31.10.2022; https://register.awmf.org/de/leitlinien/detail/073-005

Aktuelle Ernährungsmedizin 2023; 48(04): 237-290; DOI: 10.1055/a-2104-9792

https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2104-9792

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 77%

Domäne 6: 86%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Die Leitlinie gibt die PICO-Fragestellung in Form einer Schlüsselfrage an:

Wann besteht die Indikation zur präoperativen Einnahme einer Trinknahrung oder enteralen Ernährung?

Datum der Recherche

01.01.2016 - 27.12.2020

Anzahl der Studien, Studientyp, Referenzierung

10 Studien: 6 SR/MA; 4 RCT

• 6 SR/MA:
• Sowerbutts AM, Burden S, Sremanakova J, French C, Knight SR, Harrison EM. Preoperative nutrition therapy in people undergoing gastrointestinal surgery. Cochrane Database of Systematic Reviews 2024; 4: CD008879.
• Daniels SL,LeeMJ,GeorgeJetal. Prehabilitation in elective abdominal cancer surgery in older patients: systematic review and meta-analysis. BJS Open 2020; 4: 1022–1041. DOI: 10.1002/ bjs5.50347
• Bruns ERJ,ArgillanderTE,VanDenHeuvelBetal. Oral Nutrition as a Form of Pre-Operative Enhancement in Patients Undergoing Surgery for Colorectal Cancer: A Systematic Review. Surg Infect (Larchmt) 2018; 19: 1–10. DOI: 10.1089/sur.2017.143
• Gillis C,BuhlerK,BreseeLetal.EffectsofNutritionalPrehabilitation,With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gastroenterology 2018; 155: 391–410 e394. DOI: 10.1053/j.gastro.2018.05.012
• Elia M, Normand C, Norman K, Laviano A , Norman K A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in the hospital setting. Clin Nutr 2016; 35: 370-380. (MA, LoE 1+)
• Burden S, Todd C, Hill J, Lal S Pre-operative nutrition support in patients undergoing gastrointestinal surgery. Cochrane Database Syst Rev 2012; 11:CD008879. (SR, LoE 1+)

• 4 RCT:
• Kong SH, Lee HJ,Na JR et al. Effect of perioperative oral nutritional supplementation in malnourished patients who undergo gastrectomy: A prospective randomized trial. Surgery 2018; 164: 1263–1270.
• Burden ST, Hill J, Shaffer JL, Campbell M, Todd C An unblinded randomised controlled trial of preoperative oral supplements in colorectal cancer patients. J Hum Nutr Diet 2011; 24:441-448. (RCT, LoE 1+)
• Smedley F, Bowling T, James M, Stokes E, Goodger C, O'Connor O, Oldale C, Jones P, Silk D Randomized clinical trial of the effects of preoperative and postoperative oral nutritional supplements on clinical course and cost of care. Br J Surg 2004; 91:983-990. (RCT, LoE 1+)
• MacFie J, Woodcock NP, Palmer MD, Walker A, Townsend S, Mitchell CJ (2000) Oral dietary supplements in pre- and postoperative surgical patients: a prospective and randomized clinical trial. Nutrition 2000; 16:723-728. (RCT, LoE 1+)

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

Zusätzliches Material 1: Evidenztabellen

https://www.thieme-connect.de/media/akternmed/202304/supmat/10-1055-a-2104-9792-21049792-0001.pdf

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

Graduierung in der adaptierten Leitlinie nach SIGN (2014)

--> Level of Evidence nach Oxford 2011 neu eingeschätzt: LoE 1

Ggfs. Interpretation der Evidenz/ Evidence to decision

NA

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

☒ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Eventuell redaktionelle Änderungen.

Wortlaut der Empfehlung: Bei Patienten mit Mangelernährung und/oder hohem metabolischen Risiko soll vor großen abdominellen Eingriffen eine Trinknahrung (Oral Nutritional Supplement) verabreicht werden.

☐ adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

NA

Begründung für Modifikation

NA

Wortlaut der Empfehlung:

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen.

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 19: Eine enterale Ernährung soll innerhalb von 24 Stunden bei den Patienten begonnen werden, bei denen ein oraler Kostaufbau noch nicht möglich ist (A).

Dies gilt insbesondere bei:

• Patienten, bei denen die orale Kalorienzufuhr voraussichtlich in den nächsten 7 Tagen < 50 % sein wird (BM) (KKP)
• Patienten nach großen Kopf-Hals-Operationen und gastrointestinalen Resektionen wegen eines Tumors (BM) (KKP)
• Patienten mit Polytrauma und/oder schwerem Schädel-Hirn-Trauma (BM) (KKP)
• Patienten mit Mangelernährung zum Zeitpunkt der Operation (BM) (KKP) (modifiziert, Stand 2017)

Empfehlungsgrad A/KKP, Starker Konsens 100 % Zustimmung

Kapitel 5.1, S. 258

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Klinische Ernährung in der Chirurgie der Deutschen Gesellschaft für Ernährungsmedizin (DGEM) e. V.

Version 3.0, Stand: 31.10.2022; https://register.awmf.org/de/leitlinien/detail/073-005

Aktuelle Ernährungsmedizin 2023; 48(04): 237-290; DOI: 10.1055/a-2104-9792

https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2104-9792 

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 77%

Domäne 6: 86%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Die Leitlinie gibt die PICO-Fragestellung in Form einer Schlüsselfrage an:

Welche Patienten profitieren besonders von einer frühen postoperativen Ernährung?

Datum der Recherche

01.01.2016 - 27.12.2020

Anzahl der Studien, Studientyp, Referenzierung

4 Studien: 2 SR/MA; 2 RCT

• 2 SR/MA:
• Perel P, Yanagawa T, Bunn F, Roberts I, Wentz R, Pierro A Nutritional support for head-injured patients. Cochrane Database Syst Rev 2006:CD001530. (SR, LoE 1++)
• Moore FA, Feliciano DV, Andrassy RJ, McArdle AH, Booth FV, Morgenstein-Wagner TB, Kellum JM,Jr, Welling RE, Moore EE Early enteral feeding, compared with parenteral, reduces postoperative septic complications. The results of a meta-analysis. Ann Surg 1992; 216:172-183. (MA, LoE 1+)

• 2 RCT:

• Kompan L, Kremzar B, Gadzijev E, Prosek M Effects of early enteral nutrition on intestinal permeability and the development of multiple organ failure after multiple injury. Intensive Care Med 1999; 25:157-161. (RCT, LoE 1+)

• Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg 1992; 215:503-511. (RCT, LoE 1+)

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

Zusätzliches Material 1: Evidenztabellen

https://www.thieme-connect.de/media/akternmed/202304/supmat/10-1055-a-2104-9792-21049792-0001.pdf

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

Graduierung in der adaptierten Leitlinie nach SIGN (2014), siehe oben LoE zu jeder Studie

--> Level of Evidence nach Oxford 2011 neu eingeschätzt: LoE 1

Ggfs. Interpretation der Evidenz/ Evidence to decision

NA

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

☒ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Redaktionelle Änderung & „Patienten mit Polytrauma und/oder schwerem Schädel-Hirn-Trauma (BM) (KKP)“ wurde gestrichen, weil hier nicht relevant (entsprechend der Diskussion in der Expertengruppe im AG-Treffen am 02.09.2024).

Wortlaut der Empfehlung: 

Eine enterale Ernährung soll innerhalb von 24 Stunden bei den Patienten begonnen werden, bei denen ein oraler Kostaufbau noch nicht möglich ist (GoR A). Dies gilt insbesondere bei:

• Patienten, bei denen die orale Kalorienzufuhr voraussichtlich in den nächsten 7 Tagen < 50 % sein wird (EK)
• Patienten nach großen Kopf-Hals-Operationen und oberen gastrointestinalen Resektionen wegen eines Tumors (EK)
• Patienten mit Mangelernährung zum Zeitpunkt der Operation (EK)

☐ adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

Begründung für Modifikation

Wortlaut der Empfehlung:

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen.

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 21: Bei Patienten mit Mangelernährung und/oder hohem metabolischen Risiko sollte insbesondere bei Ösophagus- und Magenresektion sowie partieller Duodenopankreatektomie die intraoperative Platzierung einer nasojejunalen Sonde oder Feinnadelkatheterjejunostomie (FKJ) erfolgen (BM). (modifiziert, Stand 2017)

Empfehlungsgrad B, Starker Konsens 100 % Zustimmung

Kapitel 5.3, S. 259

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Klinische Ernährung in der Chirurgie der Deutschen Gesellschaft für Ernährungsmedizin (DGEM) e. V.

Version 3.0, Stand: 31.10.2022; https://register.awmf.org/de/leitlinien/detail/073-005

Aktuelle Ernährungsmedizin 2023; 48(04): 237-290; DOI: 10.1055/a-2104-9792

https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2104-9792

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 77%
Domäne 6: 86%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Die Leitlinie gibt die PICO-Fragestellung in Form einer Schlüsselfrage an:

Welche Patienten profitieren von einer enteralen Sondennahrung?  

Datum der Recherche

01.01.2016 - 27.12.2020

Anzahl der Studien, Studientyp, Referenzierung

9 Studien: 5 SR/MA; 2 RCT; 2 Beobachtungsstudien

• 5 Systematische Reviews/Meta-Analysen:
• Li HN, Chen Y, Dai L et al. A Meta-analysis of Jejunostomy Versus Nasoenteral Tube for Enteral Nutrition Following Esophagectomy. J Surg Res 2021; 264: 553–561. DOI: 10.1016/j.jss.2021.02.027
• Shen X, Zhuo ZG, Li G et al. Is the routine placement of a feeding jejunostomy during esophagectomy worthwhile? - a systematic review and meta-analysis. Annals of palliative medicine 2021; 10: 4232–4241. DOI: 10.21037/apm-20-2519
• Tanaka M, Heckler M, Mihaljevic AL et al. Meta-analysis of effect of routine enteral nutrition on postoperative outcomes after pancreatoduodenectomy. Br J Surg 2019; 106: 1138-1146. doi:10.1002/bjs.11217 (SR, LoE 1++)
• Gerritsen A, Besselink MG, Gouma DJ, Steenhagen E, Borel Rinkes IH, Molenaar IQ Systematic review of five feeding routes after pancreatoduodenectomy. Br J Surg 2013; 100:589-598. (Review, LoE 1+)
• Markides GA, Alkhaffaf B, Vickers Nutritional access routes following oesophagectomy--a systematic review. Eur J Clin Nutr 2011; 65:565-573. (MA, LoE 1++)

• 2 RCT:
• Zhu X, Wu Y, Qiu Y, Jiang C, Ding Y Comparative analysis of the efficacy and complications of nasojejunal and jejunostomy on patients undergoing pancreaticoduodenectomy. JPEN J Parenter Enteral Nutr;2014; 38: 996-1002. [391] (RCT, LoE 1+)
• Han-Geurts IJ, Hop WC, Verhoef C, Tran KT, Tilanus HW Randomized clinical trial comparing feeding jejunostomy with nasoduodenal tube placement in patients undergoing oesophagectomy. Br J Surg 2007; 94:31-35. (RCT, LoE 1+)

• 3 Beobachtungsstudien:
• Holmén A, Hayami M, Szabo E et al. Nutritional jejunostomy in esophagectomy for cancer, a national register-based cohort study of associations with postoperative outcomes and survival. Langenbecks Arch Surg 2021; 406: 1415–1423. DOI: 10.1007/s00423-020-02037-0
• Gerritsen A, Besselink MG, Cieslak KP et al. Efficacy and complications of nasojejunal, jejunostomy and parenteral feeding after pancreaticoduodenectomy. J Gastrointest Surg 2012; 16: 1144–1151. DOI: 10.1007/s11605-012-1887-5
• Gupta V. Benefits versus risks: a prospective audit. Feeding jejunostomy during esophagectomy. World J Surg 2009; 33: 1432–1438. DOI: 10.1007/s00268-009-0019-1

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

Zusätzliches Material 1: Evidenztabellen

https://www.thieme-connect.de/media/akternmed/202304/supmat/10-1055-a-2104-9792-21049792-0001.pdf

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

Graduierung in der adaptierten Leitlinie nach SIGN (2014)

--> Level of Evidence nach Oxford 2011 neu eingeschätzt: LoE 1

Ggfs. Interpretation der Evidenz/ Evidence to decision

NA

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

☒ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Eventuell redaktionelle Änderungen.

Wortlaut der Empfehlung: Bei Patienten mit Mangelernährung und/oder hohem metabolischen Risiko sollte insbesondere bei Ösophagus- und Magenresektion sowie partieller Duodenopankreatektomie die intraoperative Platzierung einer nasojejunalen Sonde oder Feinnadelkatheterjejunostomie (FKJ) erfolgen (BM).

☐ adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

NA

Begründung für Modifikation

NA

Wortlaut der Empfehlung:

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen.

Informationen zur Quelle

Text der Original-Empfehlung (ggf. Nr. Seite, Link)

Empfehlung 25: Bei Patienten, die perioperativ einer Ernährungstherapie bedurften, sollte die regelmäßige Erfassung des Ernährungsstatus während des Krankenhausaufenthaltes mit poststationärer Fortsetzung einschließlich Ernährungsberatung sowie ggf. oraler/enterale Supplementierung erfolgen. (BM) (modifiziert, Stand 2017)

Empfehlungsgrad B, Starker Konsens 100 % Zustimmung

Kapitel 5.4, S. 261

Quell-Leitlinie
(Titel, Versionsnummer, Zitation, ggf. Link,)

S3-Leitlinie Klinische Ernährung in der Chirurgie der Deutschen Gesellschaft für Ernährungsmedizin (DGEM) e. V.

Version 3.0, Stand: 31.10.2022; https://register.awmf.org/de/leitlinien/detail/073-005

Aktuelle Ernährungsmedizin 2023; 48(04): 237-290; DOI: 10.1055/a-2104-9792

https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2104-9792

AGREE II-Bewertung Domäne 3 + 6

Domäne 3: 77%
Domäne 6: 86%

Informationen zur Evidenzgrundlage in der Quell-Leitlinie

PICO-Fragestellung in der Quell­Leitlinie

Die Leitlinie gibt die PICO-Fragestellung in Form einer Schlüsselfrage an:

Welchen Patienten nutzt eine enterale Ernährung nach der Entlassung aus dem Krankenhaus?  

Datum der Recherche

01.01.2016 - 27.12.2020

Anzahl der Studien, Studientyp, Referenzierung

3 Studien: 

• 3 RCT:
• Meng Q, Tan S, Jiang Y et al. Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial. Clin Nutr 2021; 40: 40-46. doi:10.1016/j.clnu.2020.04.043 (RCT, LoE 1-)
• Hatao F, Chen KY, Wu JM et al. Randomized controlled clinical trial assessing the effects of oral nutritional supplements in postoperative gastric cancer patients. Langenbecks Arch Surg 2017; 402: 203-211. doi:10.1007/s00423-016-1527-8 (RCT, LoE 1-)
• Kong SH, Lee HJ, Na JR et al. Effect of perioperative oral nutritional supplementation in malnourished patients who undergo gastrectomy: A prospective randomized trial. Surgery 2018; 164: 1263-1270. doi:10.1016/j.surg.2018.05.017 (RCT, LoE 1-)

Link zu Evidenztabellen/ zusammenfassenden Evidenz­darstellung einschließlich Angabe LoE/Quality of Evidence

Zusätzliches Material 1: Evidenztabellen

https://www.thieme-connect.de/media/akternmed/202304/supmat/10-1055-a-2104-9792-21049792-0001.pdf

Sofern nicht Oxford LoE-Klassifikation bzw. GRADE-Methodik in der Quell-LL angewendet wurde: Übertragung der Evidenz­graduierung

Graduierung in der adaptierten Leitlinie nach SIGN (2014)

--> Level of Evidence nach Oxford 2011 neu eingeschätzt: LoE 2

Ggfs. Interpretation der Evidenz/ Evidence to decision

NA

Informationen zum Umgang in der Ziel-Leitlinie

Empfehlung wurde …

☐ adoptiert (Keine Modifikation der Empfehlung; 1:1-Übersetzung; ggf. Anpassung an ‚Leitliniensprache‘ in Dtl. (soll/sollte/kann). Eventuell redaktionelle Änderungen.

☒ adaptiert

Welche Modifikationen der Empfehlung wurden vorgenommen?

Hochstufung des Empfehlungsgrades von „sollte“ auf „soll“.

Begründung für Modifikation

Die adaptierte S3-Leitlinie „Klinische Ernährung in der Chirurgie“ gab aufgrund der vorliegenden Evidenz eine „sollte“-Empfehlung ab. Auf Wunsch der Patientenvertreter und der Experten dieser Leitlinie wurde in der Konsensuskonferenz (17.10.2024) abgestimmt, dass der Empfehlungsgrad von „sollte“ auf „soll“ geändert wird.

Die Erhöhung des Empfehlungsgrads wurde damit begründet, dass das Erfahrungswissen, insbesondere der Patientenvertreter aus der Selbsthilfe, aber auch der Experten zeigt, dass beim Übergang von der stationären zur ambulanten Versorgung ein Versorgungsdefizit besteht. Diese Empfehlung zielt darauf ab, eine sektorenübergreifende Versorgung sicherzustellen.

Wortlaut der Empfehlung: Bei Patienten mit onkochirurgischen Eingriffen, die stationär einer Ernährungstherapie bedurften, soll die regelmäßige Erfassung des Ernährungsstatus während des Krankenhausaufenthaltes mit poststationärer Fortsetzung einschließlich Ernährungsberatung sowie ggf. Supplementierung erfolgen.

Datum der Einschätzung

Finale Auswahl und Besprechung der zu adaptierenden Empfehlungen wurde im AG-Treffen am 02.09.2024 besprochen sowie in der Konsensuskonferenz am 17.10.2024 (Änderung des Empfehlungsgrades).