Emmeline G Peters1, Boudewijn J J Smeets2, Jesper Nors3, Christian M Back4, Jonas A Funder5, Thorbjørn Sommer6, Søren Laurberg5, Uffe S Løve4, Wouter K G Leclercq7, Gerrit D Slooter7, Tammo S de Vries Reilingh8, Johannes A Wegdam8, Grard A P Nieuwenhuijzen9, Mickaël Hiligsmann10, Marc P Buise11, Willem A Buurman12, Wouter J de Jonge13, Harm J T Rutten2, Misha D P Luyer14. 1. Department of Surgery, Catharina Hospital, Eindhoven, Netherlands; Tytgat Institute for Intestinal and Liver Research, Academic Medical Centre, Amsterdam, Netherlands. 2. Department of Surgery, Catharina Hospital, Eindhoven, Netherlands; GROW School of Oncology and Developmental Biology, Maastricht University, Maastricht, Netherlands. 3. Department of Surgery, Aarhus University Hospital, Aarhus, Denmark; Department of Surgery, Regionshospitalet Randers, Randers, Denmark. 4. Department of Surgery, Regionshospitalet Viborg, Viborg, Denmark. 5. Department of Surgery, Aarhus University Hospital, Aarhus, Denmark. 6. Department of Surgery, Regionshospitalet Randers, Randers, Denmark. 7. Department of Surgery, Máxima Medical Centre, Veldhoven, Netherlands. 8. Department of Surgery, Elkerliek Hospital, Helmond, Netherlands. 9. Department of Surgery, Catharina Hospital, Eindhoven, Netherlands. 10. Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands. 11. Department of Anaesthesiology, Catharina Hospital, Eindhoven, Netherlands. 12. School for Mental Health and Neuroscience, Maastricht University, Maastricht, Netherlands. 13. Tytgat Institute for Intestinal and Liver Research, Academic Medical Centre, Amsterdam, Netherlands. 14. Department of Surgery, Catharina Hospital, Eindhoven, Netherlands. Electronic address: misha.luyer@catharinaziekenhuis.nl.
Abstract
BACKGROUND:Postoperative ileus and anastomotic leakage severely impair recovery after colorectal resection. We investigated the effect of perioperative lipid-enriched enteral nutrition versus standard care on the risk of postoperative ileus, anastomotic leakage, and other clinical outcomes. METHODS: We did an international, multicentre, double-blind, randomised, controlled trial of patients (≥18 years) undergoing elective colorectal surgery with primary anastomosis at six clinical centres in the Netherlands and Denmark. Patients were randomly assigned (1:1), stratified by location (colonic and rectal) and type of surgery (laparoscopic and open), via online randomisation software, with block sizes of six, to receive either continuous lipid-enriched enteral tube feeding from 3 h before until 6 h after surgery (intervention) or no perioperative nutrition (control). Surgeons, patients, and researchers were masked to treatment allocation for the entire study period. The primary outcome was postoperative ileus. Secondary outcomes included anastomotic leakage, pneumonia, preoperative gastric volumes, time to functional recovery, length of hospital stay, the need for additional interventions, intensive care unit admission, postoperative inflammatory response, and surgical complications. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT02175979, and trialregister.nl, number NTR4670. FINDINGS:Between July 28, 2014, and February 20, 2017, 280 patients were randomly assigned, 15 of whom were excluded after random allocation because they fulfilled one or more exclusion criteria. 265 patients receivedperioperative nutrition (n=132) or standard care (n=133) and were included in the analyses. A postoperative ileus occurred in 37 (28%) patients in the intervention group versus 29 (22%) in the control group (risk ratio [RR] 1·09, 95% CI 0·95-1·25; p=0·24). Anastomotic leakage occurred in 12 (9%) patients in the intervention group versus 11 (8%) in the control group (RR 1·01, 95% CI 0·94-1·09; p=0·81). Pneumonia occurred in ten (8%) patients in the intervention group versus three (2%) in the control group (RR 1·06, 95% CI 1·00-1·12; p=0·051). All other secondary outcomes were similar between groups (all p>0·05). INTERPRETATION:Perioperative lipid-enriched enteral nutrition in patients undergoing elective colorectal surgery has no advantage over standard care in terms of postoperative complications. FUNDING: Netherlands Organisation for Health Research and Development (ZonMW), Fonds NutsOhra, and Danone Research.
RCT Entities:
BACKGROUND: Postoperative ileus and anastomotic leakage severely impair recovery after colorectal resection. We investigated the effect of perioperative lipid-enriched enteral nutrition versus standard care on the risk of postoperative ileus, anastomotic leakage, and other clinical outcomes. METHODS: We did an international, multicentre, double-blind, randomised, controlled trial of patients (≥18 years) undergoing elective colorectal surgery with primary anastomosis at six clinical centres in the Netherlands and Denmark. Patients were randomly assigned (1:1), stratified by location (colonic and rectal) and type of surgery (laparoscopic and open), via online randomisation software, with block sizes of six, to receive either continuous lipid-enriched enteral tube feeding from 3 h before until 6 h after surgery (intervention) or no perioperative nutrition (control). Surgeons, patients, and researchers were masked to treatment allocation for the entire study period. The primary outcome was postoperative ileus. Secondary outcomes included anastomotic leakage, pneumonia, preoperative gastric volumes, time to functional recovery, length of hospital stay, the need for additional interventions, intensive care unit admission, postoperative inflammatory response, and surgical complications. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT02175979, and trialregister.nl, number NTR4670. FINDINGS: Between July 28, 2014, and February 20, 2017, 280 patients were randomly assigned, 15 of whom were excluded after random allocation because they fulfilled one or more exclusion criteria. 265 patients received perioperative nutrition (n=132) or standard care (n=133) and were included in the analyses. A postoperative ileus occurred in 37 (28%) patients in the intervention group versus 29 (22%) in the control group (risk ratio [RR] 1·09, 95% CI 0·95-1·25; p=0·24). Anastomotic leakage occurred in 12 (9%) patients in the intervention group versus 11 (8%) in the control group (RR 1·01, 95% CI 0·94-1·09; p=0·81). Pneumonia occurred in ten (8%) patients in the intervention group versus three (2%) in the control group (RR 1·06, 95% CI 1·00-1·12; p=0·051). All other secondary outcomes were similar between groups (all p>0·05). INTERPRETATION: Perioperative lipid-enriched enteral nutrition in patients undergoing elective colorectal surgery has no advantage over standard care in terms of postoperative complications. FUNDING: Netherlands Organisation for Health Research and Development (ZonMW), Fonds NutsOhra, and Danone Research.
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