Comparing a Randomised Controlled Intervention With Observational Data.
NCT ID: NCT02763501
Last Updated: 2016-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10992 participants
INTERVENTIONAL
2010-05-31
2016-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
non-closure of mesenteric defects
Mesenteric defects are left open
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)
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
non-closure of mesenteric defects
Mesenteric defects are left open
Interventions
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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
non-closure of mesenteric defects
Mesenteric defects are left open
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* previous bariatric procedures
* primary open procedures
* missing data on handling of the mesenteric defects
18 Years
ALL
Yes
Sponsors
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The Scandinavian Obesity Surgery Registry
UNKNOWN
Region Örebro County
OTHER
Responsible Party
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Erik Stenberg, MD
DR
Related Links
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The Scandinavian Obesity Surgery Registry
Other Identifiers
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EPN 2015/097
Identifier Type: -
Identifier Source: org_study_id
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