Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782648
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2021-02-27
Brief Title:
Transit Bipartition After Sleeve Gastrectomy
Sponsor:
Ruhr University of Bochum
Organization:
Ruhr University of Bochum
Study Overview
Official Title:
Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TB-LSG
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 kgqm with a body mass index BMI 30 kgqm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None