Clinical trial NCT04782648: Transit Bipartition After Sleeve Gastrectomy
Official title: Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Weight Gain
Bariatric Surgery Candidate
Keywords: obesity
weight regain
sleeve gastrectomy
SASI bypass
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Primary outcomes:
measure: percent excess weight loss (EWL)
timeFrame: 12 months
Secondary outcomes:
measure: number of patients with improvement of type 2 diabetes
timeFrame: 12 months
measure: number of patients with improvement of gastro-esophageal reflux (GERD)
timeFrame: 12 months
measure: number of patients with improvement of hypertension
timeFrame: 12 months
measure: number of patients with improvement of sleep apnoea
timeFrame: 12 months
Other outcomes:
Locations:
city: Recklinghausen
country: Germany
facility: Klinikum Vest GmbH
state: NRW
Study officials:
affiliation: Dept. Gastroenterology, Klinikum-Vest GmbH
name: Markus Reiser, M.D.
role: PRINCIPAL_INVESTIGATOR
References: