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Completed

NCT Number: NCT02763501

Comparing a Randomised Controlled Intervention With Observational Data.

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.

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Key information

Conditions

Obesity, Morbid Body Weight Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

closure of mesenteric defects

Procedure

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

Procedure

Mesenteric defects are left open

Primary outcomes

  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 outcomes

  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])

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • The Scandinavian Obesity Surgery Registry

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
May 5, 2016
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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