Transit Bipartition After Sleeve Gastrectomy

Bariatric Surgery Candidate Clinical Trial

— TB-LSG  

Official title:

Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782648
• Other study ID #: TB-LSG-01
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: December 20, 2020

Study information

• Verified date: March 2021
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 20, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid
• Weight Gain

Intervention

Procedure:
• transit bipartition
transit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy

Locations

Country	Name	City	State
Germany	Klinikum Vest GmbH	Recklinghausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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