Comparing a Randomised Controlled Intervention With Observational Data.

Study Overview
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Brief Summary
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Comparison of participants in a randomised controlled trial (RCT) with observational data from patients operated in Sweden during the same period of time. The primary objective is to compare effects from a complex surgical intervention from RCT and observational data.

Detailed Description
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Randomised controlled trials (RCT) are golden standard for assessing interventions in medical science. Due to ethical or practical reasons, RCTs may however not always be feasible. The study objective was to test if the results from the RCT differ from observational data in a setting with a complex surgical intervention. Using the Scandinavian Obesity Surgery Registry database we intend to compare patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011, with all patients operated with the same procedure registered in the database during the same period of time. Primary end-point measures are severe complications within 30 days (safety outcome) and surgery for small bowel obstruction (efficacy outcome) within 4 years.

Official Title
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Comparing a Randomised Controlled Intervention With Observational Data.

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: closure of mesenteric defects
* Procedure: non-closure of mesenteric defects


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement Exclusion Criteria: retrocolic gastric bypass procedure previous bariatric procedures primary open procedures missing data on handling of the mesenteric defects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RCT<br>patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011. 1:1 randomization to closure of mesenteric defects by running, non-absorbable sutures | Procedure: closure of mesenteric defects<br>* Closure of mesenteric defects by use of non-absorbable running sutures in RCT; and according to the choice of the surgeon in the non-RCT<br>Procedure: non-closure of mesenteric defects<br>* Mesenteric defects are left open<br>|
| Active Comparator: non-RCT<br>patients operated with laparoscopic gastric bypass surgery outside of the RCT from May 1st 2010 until Nov 14th 2011. Intervention of mesenteric defects according to local tradition or choice of surgeon (non-randomized) | Procedure: closure of mesenteric defects<br>* Closure of mesenteric defects by use of non-absorbable running sutures in RCT; and according to the choice of the surgeon in the non-RCT<br>Procedure: non-closure of mesenteric defects<br>* Mesenteric defects are left open<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe postoperative complications within 30 days | Specified as Clavien-Dindo grade 3b or more | 30 days | 
| reoperation for small bowel obstruction | Efficacy outcome: Number of participants with reoperation due to small bowel obstruction defined as acute symptoms of bowel obstruction with findings suggestive of small bowel obstruction during surgery | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative length of stay |  | 30 days | 
| length of the operation |  | intraoperative | 
| specific postoperative complications | leakage or deep intra-abdominal infection, bleeding requiring intervention, small bowel obstruction/ileus, port-related complications, wound dehiscence, other wound complications (mainly superficial wound infections), anastomotic stricture, marginal ulcer, cardiovascular length of the operation event, pulmonary complication (other than pulmonary embolism), venous thromboembolism (including pulmonary embolism), urinary tract infection and other (in this case specified) complication | 30 days | 
| weight-loss at 2 years after surgery | specified as excessive weight-loss (% excess weight loss = 100 x [initial weight-postoperative weight]/[initial weight-weight corresponding to BMI 25 kg/m2]) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, gastric bypass, intestinal obstruction, postoperative complication, methods, laparoscopy