Transit Bipartition After Sleeve Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy

Conditions
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Obesity, Morbid, Weight Gain, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: transit bipartition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: endocrine disorders other than T2DM, major psychiatric disorders, ASA ≥ III, pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: transit bipartition|transit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent excess weight loss (EWL) | preoperative weight-current weight / preoperative weight-ideal weight x 100 (ideal weight defined as BMI 25 kg/qm | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with improvement of type 2 diabetes | number of patients with HbA1c <6 %, fasting blood glucose <100 mg/dL in the absence of antidiabetic medications | 12 months | 
| number of patients with improvement of gastro-esophageal reflux (GERD) | number of patients with no GERD symptoms, reflux symptom score (RSI) < 13 in the absence of medication | 12 months | 
| number of patients with improvement of hypertension | number of patients with normotensive blood pressure (<120/80 mmHg) in the absence of antihypertensive medication | 12 months | 
| number of patients with improvement of sleep apnoea | number of patients with discontinued use of sleep apnea treatment (continuous positive airway pressure - CPAP) based on improved symptoms and Obstructive Sleep Apnoea (OSA) screening. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SASI bypass, obesity, weight regain, sleeve gastrectomy