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Comparing a Randomised Controlled Intervention With Observational Data.

NCT02763501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10992

Last updated 2016-10-17

No results posted yet for this study

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.

Conditions

  • Obesity, Morbid

Interventions

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

Sponsors & Collaborators

  • The Scandinavian Obesity Surgery Registry

    collaborator UNKNOWN

  • Region Örebro County

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-12-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763501 on ClinicalTrials.gov