Transit Bipartition After Sleeve Gastrectomy | NCT04782648

Studies
Transit Bipartition After Sleeve Gastrectomy

NCT04782648

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Mar 4, 2021Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Obesity, Morbid
Weight Gain
Bariatric Surgery Candidate

Interventions

transit bipartition

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Dec 20, 2020Actual

First Submitted Date

Feb 27, 2021

First Submission Date that Met QC Criteria

Mar 3, 2021

First Posted Date

Mar 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2021

Last Update Posted Date

Mar 4, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Markus Reiser, M.D., Chief Dept. Gastroenterology, Ruhr University of BochumPrincipal Investigator

Lead Sponsor

Ruhr University of BochumOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transit bipartition	Procedure	transit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy		SASI bypass

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percent excess weight loss (EWL)	preoperative weight-current weight / preoperative weight-ideal weight x 100 (ideal weight defined as BMI 25 kg/qm	12 months

Secondary Outcomes

Measure	Description	Time Frame
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	12 months
number of patients with improvement of gastro-esophageal reflux (GERD)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Morbidly obese patients (BMI > 30) who underwent transit bipartition (SASI bypass) for inadequate weight loss or weight regain after laparoscopic sleeve gastrectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus Reiser, M.D.	Dept. Gastroenterology, Klinikum-Vest GmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Vest GmbH		Recklinghausen	North Rhine-Westphalia	45657	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D015430	Weight Gain
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

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