Duodenal Switch With a Standard Versus Long Alimentary Limb

Bariatric Surgery Candidate Clinical Trial

— Long_limb_DS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097926
• Other study ID #: DS long Limb
• Status: Completed
• Phase: N/A
• First received: January 2, 2017
• Last updated: March 23, 2018
• Start date: May 2013
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Metabolic Diseases
• Metabolism Disorder
• Obesity, Morbid

Intervention

Procedure:
• Long alimentary limb BPD-DS
BPD-DS with a long strict alimentary limb and a 100-cm common channel.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resolution of Type 2 Diabetes	Resolution rate of T2DM (based on normalized HbA1c without medication)	6,12,18,24 months
Other	Resolution of Hypertension	Resolution rate of hypertension, base on normalized blood pressure without medication	6,12,18,24 months
Other	Resolution of dyslipidemia	Percentage of patients with normalized cholesterol without medication	6,12,18,24 months
Other	Resolution of sleep apnea	Percentage of patients with normalized sleep apnea testing without airway support	6,12,18,24 months
Primary	Total weight change	Changes in total body weight, in kg, from baseline	6, 12, 18, 24 months
Secondary	Changes in Gastro-intestinal side-effects scores	Gastro-intestinal symptoms assessed by measuring changes in GI Score	6,12,18,24 months
Secondary	Changes in Quality of life	Measure of Quality of life using Short-Form 36	6, 12, 18, 24 months