Transit Bipartition After Sleeve Gastrectomy (TB-LSG)

Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Weight Gain; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: transit bipartition

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Recklinghausen, NRW, Germany, 45657
      • Klinikum VEST GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Morbidly obese patients (BMI > 30) who underwent transit bipartition (SASI bypass) for inadequate weight loss or weight regain after laparoscopic sleeve gastrectomy

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Markus Reiser, M.D., Dept. Gastroenterology, Klinikum-Vest GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: obesity; sleeve gastrectomy; weight regain; SASI bypass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Obesity, Morbid; Weight Gain
• Other Study ID Numbers: TB-LSG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No