Comparing a Randomised Controlled Intervention With Observational Data.

Region Örebro County

Status: Completed

Conditions: Obesity, Morbid

Treatments: Procedure: non-closure of mesenteric defects; Procedure: closure of mesenteric defects

Study type: Interventional

Funder types: Other

Identifiers

NCT02763501

EPN 2015/097

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,992 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,992 participants in 2 patient groups

RCT

Active Comparator group

Description:

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

Treatment:

Procedure: non-closure of mesenteric defects

Procedure: closure of mesenteric defects

non-RCT

Active Comparator group

Description:

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)

Treatment:

Procedure: non-closure of mesenteric defects

Procedure: closure of mesenteric defects