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Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial
Örebro University, School of Health Sciences. Department of Surgery.ORCID iD: 0000-0003-4958-1611
Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
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2016 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 387, no 10026, 1397-1404 p.Article in journal (Refereed) Published
Resource type
Text
Abstract [en]

Background: Small bowel obstruction due to internal hernia is a common and potentially serious complication after laparoscopic gastric bypass surgery. Whether closure of surgically created mesenteric defects might reduce the incidence is unknown, so we did a large randomised trial to investigate.

Method: This study was a multicentre, randomised trial with a two-arm, parallel design done at 12 centres for bariatric surgery in Sweden. Patients planned for laparoscopic gastric bypass surgery at any of the participating centres were off ered inclusion. During the operation, a concealed envelope was opened and the patient was randomly assigned to either closure of mesenteric defects beneath the jejunojejunostomy and at Petersen's space or non-closure. After surgery, assignment was open label. The main outcomes were reoperation for small bowel obstruction and severe postoperative complications. Outcome data and safety were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials. gov, number NCT01137201.

Findings: Between May 1, 2010, and Nov 14, 2011, 2507 patients were recruited to the study and randomly assigned to closure of the mesenteric defects (n= 1259) or non-closure (n= 1248). 2503 (99.8%) patients had follow-up for severe postoperative complications at day 30 and 2482 (99.0%) patients had follow-up for reoperation due to small bowel obstruction at 25 months. At 3 years after surgery, the cumulative incidence of reoperation because of small bowel obstruction was signifi cantly reduced in the closure group (cumulative probability 0.055 for closure vs 0.102 for non-closure, hazard ratio 0.56, 95% CI 0.41-0.76, p= 0.0002). Closure of mesenteric defects increased the risk for severe postoperative complications (54 [4.3%] for closure vs 35 [2.8%] for non-closure, odds ratio 1.55, 95% CI 1.01-2.39, p= 0.044), mainly because of kinking of the jejunojejunostomy.

Interpretation: The results of our study support the routine closure of the mesenteric defects in laparoscopic gastric bypass surgery. However, closure of the mesenteric defects might be associated with increased risk of early small bowel obstruction caused by kinking of the jejunojejunostomy.

Place, publisher, year, edition, pages
Elsevier, 2016. Vol. 387, no 10026, 1397-1404 p.
National Category
Family Medicine
Research subject
Family Medicine
Identifiers
URN: urn:nbn:se:oru:diva-50057DOI: 10.1016/S0140-6736(15)01126-5ISI: 000373217500032PubMedID: 26895675Scopus ID: 2-s2.0-84958064283OAI: oai:DiVA.org:oru-50057DiVA: diva2:925454
Note

Funding Agencies:

Örebro County Council

Stockholm City Council

Erling-Persson Family Foundation

Available from: 2016-05-02 Created: 2016-05-02 Last updated: 2016-09-08Bibliographically approved
In thesis
1. Preventing complications in bariatric surgery
Open this publication in new window or tab >>Preventing complications in bariatric surgery
2016 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Obesity is a major public health problem. Bariatric surgery is currently the only available treatment that offers sufficient weight-loss and metabolic benefits over time. Although bariatric surgery is considered safe now, serious complications still occur. The aim of this thesis was to identify factors associated with an increased risk for postoperative complication after laparoscopic gastric bypass surgery.

Study I included patients operated with laparoscopic gastric bypass surgery in Sweden from May 2007 until September 2012. The risk for serious complication was low (3.4%). Suffering an intraoperative adverse event or conversion of the operation to open surgery were the strongest risk factors for postoperative complication. The annual operative volume and experience of the procedure at the institution were also important risk factors. Patient-specific risk factors appeared to be less important although age was associated with an increased risk. In Study II, a raised glycated haemoglobin A1c (HbA1c) was evaluated as a risk factor for serious postoperative complications in non-diabetics. A higher incidence of serious postoperative complications was seen with elevated HbA1c values, even at levels classified as ‘‘pre-diabetic’’.

Study III was a multicentre, randomised clinical trial (RCT). 2507 patients planned for laparoscopic gastric bypass surgery were randomised to either mesenteric defects closure or non-closure. Closure of the mesenteric defects reduced the rate of reoperation for small bowel obstruction from 10.2% to 5.5% at 3 years after surgery. A small increase in the rate of serious postoperative complication within the first 30 days was seen with mesenteric defects closure. This relatively small increase in risk was however outweighed by the marked reduction of later reoperations for small bowel obstruction.

Study IV was a comparison between study III and an observational study on the same population under the same period of time. Although the observational study reached the same conlusion as the RCT, the efficacy of mesenteric defects closure was less pronounced. Observational studies may thus be an alternative to RCTs under situations when RCTs are not feasible. The efficacy may however be underestimated.

Place, publisher, year, edition, pages
Örebro: Örebro university, 2016. 103 p.
Series
Örebro Studies in Medicine, ISSN 1652-4063 ; 147
Keyword
postoperative complications, bariatric surgery, morbid obesity, risk factor, randomised clinical trial, haemoglobin A1c, prevention
National Category
Surgery
Research subject
Surgery
Identifiers
urn:nbn:se:oru:diva-50649 (URN)978-91-7529-149-9 (ISBN)
Public defence
2016-10-07, Campus USÖ, hörsal C1, Södra Grev Rosengatan 32, Örebro, 09:00 (English)
Opponent
Supervisors
Available from: 2016-06-09 Created: 2016-06-09 Last updated: 2017-05-09Bibliographically approved

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