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NCT Number: NCT04782648

Transit Bipartition After 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.

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Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Vest GmbH

Recklinghausen, North Rhine-Westphalia, 45657, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transit bipartition

Procedure

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

Other names: SASI bypass

Primary outcomes

  1. percent excess weight loss (EWL)

    Time frame: 12 months

    preoperative weight-current weight / preoperative weight-ideal weight x 100 (ideal weight defined as BMI 25 kg/qm

Secondary outcomes

  1. number of patients with improvement of type 2 diabetes

    Time frame: 12 months

    number of patients with HbA1c <6 %, fasting blood glucose <100 mg/dL in the absence of antidiabetic medications

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

    Time frame: 12 months

    number of patients with no GERD symptoms, reflux symptom score (RSI) < 13 in the absence of medication

  3. number of patients with improvement of hypertension

    Time frame: 12 months

    number of patients with normotensive blood pressure (<120/80 mmHg) in the absence of antihypertensive medication

  4. number of patients with improvement of sleep apnoea

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy

Acronym: TB-LSG

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 4, 2021
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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