Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

NCT ID: NCT05189574

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-03

Study Completion Date

2021-12-17

Brief Summary

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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

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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).

Conditions

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Anastomotic Leak

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Endoscopic negative pressure therapy

Endoscopic placement of a sponge in/at staple line leaks under negative pressure.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Markus Reiser, M.D.

Chief Dept. Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Reiser, MD

Role: PRINCIPAL_INVESTIGATOR

Chief Dept. Medicine and Gastroenterology

Locations

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Klinikum Vest GmbH

Recklinghausen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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EVac-LSGL

Identifier Type: -

Identifier Source: org_study_id

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