NCT04782648

Transit Bipartition After Sleeve Gastrectomy

Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Retrospective analysis of 100 morbidly obese patients who underwent a transit bipartition (TB) procedure ("Single Anastomosis Sleeve Ileal bypass") for inadequate weight loss or weight recidivism after a previous sleeve gastrectomy. Data were collected prospectively in strictly pseudonymous form. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux) as well as safety.

Detailed description

Prospective data base of 100 consecutive morbidly obese patients who had undergone transit bipartition (TB, also termed "Single Anastomosis Sleeve Ileal bypass") after a previous sleeve gastrectomy (LSG). Inclusion criteria were TB for excess weight loss (EWL) \< 50% ≥ 12 months post LSG or weight recidivism of \> 5 kg/qm with a body mass index (BMI) \> 30 kg/qm. Patients with endocrine disorders other than type 2 diabetes mellitus (T2D), major psychiatric disorders, American Society of Anesthesiologists (ASA) III and higher or pregnant patients were excluded from the study. Data were prospectively collected in strictly pseudonymous form. Follow up time points were at 1, 3, 6 and 12 months following TB. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities such as T2D, hypertension, sleep apnea, gastroesophageal reflux as well as safety.

Conditions

• Obesity, Morbid
• Weight Gain
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
PROCEDURE	transit bipartition	transit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-11-30
• Completion: 2020-12-20
• First posted: 2021-03-04
• Last updated: 2021-03-04

Locations

1 site across 1 country: Germany