Status:

COMPLETED

Comparing a Randomised Controlled Intervention With Observational Data.

Lead Sponsor:

Region Örebro County

Collaborating Sponsors:

The Scandinavian Obesity Surgery Registry

Conditions:

Obesity, Morbid

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 f...

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 objecti...

Eligibility Criteria

Inclusion

  • The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement

Exclusion

  • retrocolic gastric bypass procedure
  • previous bariatric procedures
  • primary open procedures
  • missing data on handling of the mesenteric defects

Key Trial Info

Start Date :

May 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2016

Estimated Enrollment :

10992 Patients enrolled

Trial Details

Trial ID

NCT02763501

Start Date

May 1 2010

End Date

May 1 2016

Last Update

October 17 2016

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