Comparing a Randomised Controlled Intervention With Observational Data.

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: closure of mesenteric defects; Procedure: non-closure of mesenteric defects

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10992
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RCT; 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; 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; Procedure: non-closure of mesenteric defects; Mesenteric defects are left open
Active Comparator: non-RCT; 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; 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; Procedure: non-closure of mesenteric defects; Mesenteric defects are left open

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: The Scandinavian Obesity Surgery Registry

Publications and helpful links

Helpful Links

• The Scandinavian Obesity Surgery Registry

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: postoperative complication; bariatric surgery; laparoscopy; gastric bypass; methods; intestinal obstruction
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: EPN 2015/097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Group data will be published. Deidentified individual participant data for all primary and secondary outcomes will be available after study completion.