An observational study in Obesity, Morbid, Weight Gain and Bariatric Surgery Candidate, sponsored by Ruhr University of Bochum. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by Ruhr University of Bochum · Observational
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.
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 100 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.
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Morbidly obese patients (BMI > 30) who underwent transit bipartition (SASI bypass) for inadequate weight loss or weight regain after laparoscopic sleeve gastrectomy
Exclusion Criteria:
transit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy
Also known as: SASI bypass
percent excess weight loss (EWL)
preoperative weight-current weight / preoperative weight-ideal weight x 100 (ideal weight defined as BMI 25 kg/qm
Time frame: 12 months
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 months
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Ruhr University of Bochum