Long alimentary limb BPD-DS
ProcedureBPD-DS with a long strict alimentary limb and a 100-cm common channel.
NCT Number: NCT03097926
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BPD-DS with a long strict alimentary limb and a 100-cm common channel.
Time frame: 6, 12, 18, 24 months
Changes in total body weight, in kg, from baseline
Time frame: 6,12,18,24 months
Gastro-intestinal symptoms assessed by measuring changes in GI Score
Time frame: 6, 12, 18, 24 months
Measure of Quality of life using Short-Form 36
Time frame: 6,12,18,24 months
Resolution rate of T2DM (based on normalized HbA1c without medication)
Time frame: 6,12,18,24 months
Resolution rate of hypertension, base on normalized blood pressure without medication
Time frame: 6,12,18,24 months
Percentage of patients with normalized cholesterol without medication
Time frame: 6,12,18,24 months
Percentage of patients with normalized sleep apnea testing without airway support
Laval University
Other
Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.
Acronym: Long_limb_DS
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.
Published trials that share one or more normalized conditions with this study.
NCT03489538
Avitaminosis, Bariatric Surgery Candidate
Vienna, Austria
View Trial DetailsNCT03642197
Bariatric Surgery Candidate, Behavior
Columbus, Ohio, United States
View Trial DetailsNCT06297928
Bariatric Surgery Candidate, Body Weight
Barcelona, Spain
View Trial DetailsNCT05653115
Bariatric Surgery Candidate, Body Weight
Nice, France
View Trial Details