Transit Bipartition After Sleeve Gastrectomy

NCT04782648 | Completed

• 1 other identifier: TB-LSG-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Morbid; Weight Gain; Bariatric Surgery Candidate

Keywords

obesity; weight regain; sleeve gastrectomy; SASI bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• number of patients with improvement of type 2 diabetes

  12 months

• number of patients with improvement of gastro-esophageal reflux (GERD)

  12 months

• number of patients with improvement of hypertension

  12 months

• number of patients with improvement of sleep apnoea

  12 months

Interventions

transit bipartition PROCEDURE

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

Also known as: SASI bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• endocrine disorders other than T2DM, major psychiatric disorders, ASA ≥ III, pregnancy.

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Klinikum Vest GmbH

Recklinghausen, North Rhine-Westphalia, 45657, Germany

Location

MeSH Terms

Conditions

Obesity, Morbid; Weight Gain; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Markus Reiser, M.D.

  Dept. Gastroenterology, Klinikum-Vest GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Dept. Gastroenterology

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 4, 2021
• Study Start: November 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: December 20, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

DE (1)