Transit Bipartition After Sleeve Gastrectomy

NCT ID: NCT04782648

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-12-20

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

transit bipartition

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

Intervention Type: PROCEDURE

Other Intervention Names

SASI bypass

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Markus Reiser, M.D.

Chief Dept. Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Reiser, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. Gastroenterology, Klinikum-Vest GmbH

Locations

Klinikum Vest GmbH

Recklinghausen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

TB-LSG-01

Identifier Type: -

Identifier Source: org_study_id