Skip to content

Duodenal Switch With a Standard Versus Long Alimentary Limb

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03097926
Acronym
Long_limb_DS
Enrollment
20
Registered
2017-03-31
Start date
2013-05-31
Completion date
2018-03-31
Last updated
2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Metabolism Disorder, Obesity, Morbid

Brief 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.

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.

Interventions

PROCEDURELong alimentary limb BPD-DS

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

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total weight change6, 12, 18, 24 monthsChanges in total body weight, in kg, from baseline

Secondary

MeasureTime frameDescription
Changes in Gastro-intestinal side-effects scores6,12,18,24 monthsGastro-intestinal symptoms assessed by measuring changes in GI Score
Changes in Quality of life6, 12, 18, 24 monthsMeasure of Quality of life using Short-Form 36

Other

MeasureTime frameDescription
Resolution of sleep apnea6,12,18,24 monthsPercentage of patients with normalized sleep apnea testing without airway support
Resolution of dyslipidemia6,12,18,24 monthsPercentage of patients with normalized cholesterol without medication
Resolution of Type 2 Diabetes6,12,18,24 monthsResolution rate of T2DM (based on normalized HbA1c without medication)
Resolution of Hypertension6,12,18,24 monthsResolution rate of hypertension, base on normalized blood pressure without medication

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026