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OpenTrials
Completed

NCT Number: NCT03097926

Duodenal Switch With a Standard Versus Long Alimentary Limb

The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein deficiency, vitamin and trace element deficit compared to standard BPD-DS.

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Key information

About this study

This two-group, randomized, single-blind pilot study is conducted in a university-affiliated tertiary care center. The study protocol was approved by our ethic committee. Enrollment and randomization of the patients occurred between May 20163 and June 2015. Patients are undergoing follow-up evaluation. Patients were initially referred to our center for a bariatric surgery evaluation. Eligible patients were 18 years of age or older and met the criteria for a laparoscopic biliopancreatic diversion. Patients were excluded if they had a BMI ≥ 50 mg/m², a pacemaker, cirrhosis or if they were planing pregnancy in the next 2 years. Each patient was required to provide written informed consent. Patients were randomly assigned in a 1:1 ratio to undergo a standard biliopancreatic diversion (control group) or a modified biliopancreatic diversion with a longer strict alimentary limb (study group). A sealed envelope with the assignation was given to the surgeon in the operation room just before the procedure. Patients are followed every 6 months after surgery, up to 24-months for clinical evaluation, resolution of comorbidities, evaluation of side-effects, quality of life, bioimpedance testing and bloodwork.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Candidates for a biliopancreatic diversion, BMI above 35 with comorbidities or above 40 without comorbidities

Exclusion criteria

  • BMI ≥ 50 mg/m², pacemaker, cirrhosis or planning pregnancy in the next 2 years, hypoalbuminemia, irritable bowel syndrome.

Treatment and study plan

Long alimentary limb BPD-DS

Procedure

BPD-DS with a long strict alimentary limb and a 100-cm common channel.

Primary outcomes

  1. Total weight change

    Time frame: 6, 12, 18, 24 months

    Changes in total body weight, in kg, from baseline

Secondary outcomes

  1. Changes in Gastro-intestinal side-effects scores

    Time frame: 6,12,18,24 months

    Gastro-intestinal symptoms assessed by measuring changes in GI Score

  2. Changes in Quality of life

    Time frame: 6, 12, 18, 24 months

    Measure of Quality of life using Short-Form 36

Other outcomes

  1. Resolution of Type 2 Diabetes

    Time frame: 6,12,18,24 months

    Resolution rate of T2DM (based on normalized HbA1c without medication)

  2. Resolution of Hypertension

    Time frame: 6,12,18,24 months

    Resolution rate of hypertension, base on normalized blood pressure without medication

  3. Resolution of dyslipidemia

    Time frame: 6,12,18,24 months

    Percentage of patients with normalized cholesterol without medication

  4. Resolution of sleep apnea

    Time frame: 6,12,18,24 months

    Percentage of patients with normalized sleep apnea testing without airway support

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.

Acronym: Long_limb_DS

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2017
Registry last updated
Mar 27, 2018

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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