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Comparing a Randomised Controlled Intervention With Observational Data.

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ClinicalTrials.gov Identifier: NCT02763501
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
The Scandinavian Obesity Surgery Registry
Information provided by (Responsible Party):
Erik Stenberg, MD, Region Örebro County

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: closure of mesenteric defects Procedure: non-closure of mesenteric defects Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10992 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing a Randomised Controlled Intervention With Observational Data.
Study Start Date : May 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: 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

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

Active Comparator: 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)

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




Primary Outcome Measures :
  1. severe postoperative complications within 30 days [ Time Frame: 30 days ]
    Specified as Clavien-Dindo grade 3b or more

  2. reoperation for small bowel obstruction [ Time Frame: 4 years ]
    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


Secondary Outcome Measures :
  1. postoperative length of stay [ Time Frame: 30 days ]
  2. length of the operation [ Time Frame: intraoperative ]
  3. specific postoperative complications [ Time Frame: 30 days ]
    leakage or deep intra-abdominal infection, bleeding requiring intervention, small bowel obstruction/ileus, port-related complications, wound dehiscence, other wound complications (mainly superficial wound infections), anastomotic stricture, marginal ulcer, cardiovascular length of the operation event, pulmonary complication (other than pulmonary embolism), venous thromboembolism (including pulmonary embolism), urinary tract infection and other (in this case specified) complication

  4. weight-loss at 2 years after surgery [ Time Frame: 2 years ]
    specified as excessive weight-loss (% excess weight loss = 100 x [initial weight-postoperative weight]/[initial weight-weight corresponding to BMI 25 kg/m2])



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Additional Information:
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Responsible Party: Erik Stenberg, MD, DR, Region Örebro County
ClinicalTrials.gov Identifier: NCT02763501     History of Changes
Other Study ID Numbers: EPN 2015/097
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Group data will be published. Deidentified individual participant data for all primary and secondary outcomes will be available after study completion.
Keywords provided by Erik Stenberg, MD, Region Örebro County:
bariatric surgery
gastric bypass
intestinal obstruction
postoperative complication
methods
laparoscopy
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms