Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

Completed

• Conditions: Anastomotic Leak

• Registration Number: NCT05189574
• Lead Sponsor: Ruhr University of Bochum

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).

Study Timeline

• Study Start: 2020-01-03
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-17
• Study First Submitted: 2021-12-19
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-08
• Last Update Submitted: 2022-01-08
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of endoscopic interventions	up to 16 weeks	Number of endoscopic interventions in each patient
Hospital stay	up to 24 weeks	Time of hospital stay for each patient
Mortality	up to 24 weeks	Mortality rate during hospital stay

Trial Locations

Locations (1)

Klinikum Vest GmbH; 🇩🇪 Recklinghausen, NRW, Germany