NCT02763501

Comparing a Randomised Controlled Intervention With Observational Data.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,992 (actual)
• Sponsor: Region Örebro County · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-12-01
• Completion: 2016-05-01
• First posted: 2016-05-05
• Last updated: 2016-10-17