Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks | NCT05189574

Studies
Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

NCT05189574

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Jan 12, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Anastomotic Leak

Interventions

Endoscopic negative pressure therapy

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

Jan 2022

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

Jan 3, 2020Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Dec 17, 2021Actual

First Submitted Date

Dec 19, 2021

First Submission Date that Met QC Criteria

Jan 8, 2022

First Posted Date

Jan 12, 2022Actual

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

Jan 8, 2022

Last Update Posted Date

Jan 12, 2022Actual

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

Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.

Detailed Description

Clinical data of 40 cases of post-SG proximal staple line leak treated with ENPT are analysed. Success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).

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

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic negative pressure therapy	Procedure	Endoscopic placement of a sponge in/at staple line leaks under negative pressure.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with closure of staple line leak	Resolution of the fistula with no further need for intervention (surgical or endoscopic).	up to 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of endoscopic interventions	Number of endoscopic interventions in each patient	up to 16 weeks
Hospital stay	Time of hospital stay for each patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
Age 18 years or older.
Written informed consent.

Exclusion Criteria:

Declined informed consent.
Leaks detected later than 30 days after surgery.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients older 18 years who underwent laparoscopic sleeve gastrectomy for morbid obesity and developed a proximal staple line leak within 30 days.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus Reiser, MD	Chief Dept. Medicine and Gastroenterology	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057868	Anastomotic Leak

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided