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NCT02671331 · ClinicalTrials.gov registry record
Loop Duodenal Switch Surgery in Morbidly Obese Patients
A clinical trial, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- 1
- Enrollment target
NCT02671331: Clinical Trial study, sponsored by Medical College of Wisconsin.
NCT02671331 is a clinical trial that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02671331 was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
Study Summary
The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS procedure is safer and easier to perform as it only requires one anastomosis compared to the BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic comorbidities, including type-2 diabetes mellitus. However, the initial publications of the loop DS still resulted in a small number of patients with total protein malnutrition. For this reason, the investigators will study the loop DS with a modification of the originally published technique with a longer common channel limb (300 cm) to reduce the risk of protein malnutrition For patients with a BMI \>50, many are limited to just a sleeve gastrectomy as other bariatric procedures are technically challenging with increased operative risk. A loop duodenal switch may be a safer operation with improved weight loss for the super-morbidly obese patient.
Primary Outcome
Excess weight loss is a common metric for reporting weight loss after bariatric surgery. The EWL is calculated from an ideal body mass index (BMI) of 25 kg/m\^2 and considers weight before surgery and at 12 months post-procedure.
Interventions
- PROCEDURE Loop duodenal switch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-07 |
Why NCT02671331 stopped before completion
NCT02671331 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Loop duodenal switch is the first listed.
NCT02671331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02671331 about?
NCT02671331 is a clinical study titled "Loop Duodenal Switch Surgery in Morbidly Obese Patients". The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Preliminary data from San...
What is the current status of trial NCT02671331?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2016-01. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02671331?
The interventions under investigation include: Loop duodenal switch (PROCEDURE).
Who is sponsoring clinical trial NCT02671331?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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