Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

January 8, 2022 updated by: Markus Reiser, M.D., Ruhr University of Bochum

Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Recklinghausen, NRW, Germany, 45657
        • Klinikum VEST GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of endoscopic interventions
Time Frame: up to 16 weeks
Number of endoscopic interventions in each patient
up to 16 weeks
Hospital stay
Time Frame: up to 24 weeks
Time of hospital stay for each patient
up to 24 weeks
Mortality
Time Frame: up to 24 weeks
Mortality rate during hospital stay
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Markus Reiser, MD, Chief Dept. Medicine and Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2020

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

December 17, 2021

Study Registration Dates

First Submitted

December 19, 2021

First Submitted That Met QC Criteria

January 8, 2022

First Posted (ACTUAL)

January 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2022

Last Update Submitted That Met QC Criteria

January 8, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVac-LSGL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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