Duodenal Switch With a Standard Versus Long Alimentary Limb (Long_limb_DS)

Prospective Randomized Trial of 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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Bariatric Surgery Candidate; Metabolism Disorder
• Intervention / Treatment: Procedure: Long alimentary limb BPD-DS

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard BPD-DS; Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel	Procedure: Long alimentary limb BPD-DS; BPD-DS with a long strict alimentary limb and a 100-cm common channel.
Experimental: Long alimentary limb BPD-DS; BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel	Procedure: Long alimentary limb BPD-DS; BPD-DS with a long strict alimentary limb and a 100-cm common channel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total weight change	Changes in total body weight, in kg, from baseline	6, 12, 18, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gastro-intestinal side-effects scores	Gastro-intestinal symptoms assessed by measuring changes in GI Score	6,12,18,24 months
Changes in Quality of life	Measure of Quality of life using Short-Form 36	6, 12, 18, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of Type 2 Diabetes	Resolution rate of T2DM (based on normalized HbA1c without medication)	6,12,18,24 months
Resolution of Hypertension	Resolution rate of hypertension, base on normalized blood pressure without medication	6,12,18,24 months
Resolution of dyslipidemia	Percentage of patients with normalized cholesterol without medication	6,12,18,24 months
Resolution of sleep apnea	Percentage of patients with normalized sleep apnea testing without airway support	6,12,18,24 months

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Principal Investigator: Laurent Biertho, MD, Quebec Heart and Lung Institute

Publications and helpful links

General Publications

• Malo FC, Marion A, Rioux A, Lebel S, Hould F, Julien F, Marceau S, Lescelleur O, Lafortune A, Bouvet-Bouchard L, Biertho L. Long Alimentary Limb Duodenal Switch (LADS): an Exploratory Randomized Trial, Results at 2 Years. Obes Surg. 2020 Dec;30(12):5047-5058. doi: 10.1007/s11695-020-04968-5. Epub 2020 Sep 17.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: March 26, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; Metabolic Diseases
• Other Study ID Numbers: DS long Limb

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Publication in peer-reviewed journal