Comparing a Randomised Controlled Intervention With Observational Data.

Obesity, Morbid Clinical Trial

Official title:

Comparing a Randomised Controlled Intervention With Observational Data.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763501
• Other study ID #: EPN 2015/097
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: October 13, 2016
• Start date: May 2010
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10992
• Est. completion date: May 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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
• non-closure of mesenteric defects
Mesenteric defects are left open

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	The Scandinavian Obesity Surgery Registry

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severe postoperative complications within 30 days	Specified as Clavien-Dindo grade 3b or more	30 days
Primary	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	postoperative length of stay		30 days
Secondary	length of the operation		intraoperative
Secondary	specific postoperative complications	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	30 days
Secondary	weight-loss at 2 years after surgery	specified as excessive weight-loss (% excess weight loss = 100 x [initial weight-postoperative weight]/[initial weight-weight corresponding to BMI 25 kg/m2])	2 years

External Links

•   The Scandinavian Obesity Surgery Registry