Comparing a Randomised Controlled Intervention With Observational Data.
1 other identifier
interventional
10,992
0 countries
N/A
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 from a complex surgical intervention from RCT and observational data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedOctober 17, 2016
October 1, 2016
4.6 years
May 3, 2016
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
severe postoperative complications within 30 days
Specified as Clavien-Dindo grade 3b or more
30 days
reoperation for small bowel obstruction
Efficacy outcome: Number of participants with reoperation due to small bowel obstruction defined as acute symptoms of bowel obstruction with findings suggestive of small bowel obstruction during surgery
4 years
Secondary Outcomes (4)
postoperative length of stay
30 days
length of the operation
intraoperative
specific postoperative complications
30 days
weight-loss at 2 years after surgery
2 years
Study Arms (2)
RCT
ACTIVE COMPARATORpatients 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
non-RCT
ACTIVE COMPARATORpatients 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)
Interventions
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
Eligibility Criteria
You may qualify if:
- The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement
You may not qualify if:
- retrocolic gastric bypass procedure
- previous bariatric procedures
- primary open procedures
- missing data on handling of the mesenteric defects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Örebro Countylead
- The Scandinavian Obesity Surgery Registrycollaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR
Study Record Dates
First Submitted
May 3, 2016
First Posted
May 5, 2016
Study Start
May 1, 2010
Primary Completion
December 1, 2014
Study Completion
May 1, 2016
Last Updated
October 17, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share
Group data will be published. Deidentified individual participant data for all primary and secondary outcomes will be available after study completion.