Status:
COMPLETED
Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks
Lead Sponsor:
Ruhr University of Bochum
Conditions:
Anastomotic Leak
Eligibility:
All Genders
18-70 years
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 d...
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 endosc...
Eligibility Criteria
Inclusion
- Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
- Age 18 years or older.
- Written informed consent.
Exclusion
- Declined informed consent.
- Leaks detected later than 30 days after surgery.
Key Trial Info
Start Date :
January 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05189574
Start Date
January 3 2020
End Date
December 17 2021
Last Update
January 12 2022
Active Locations (1)
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1
Klinikum Vest GmbH
Recklinghausen, North Rhine-Westphalia, Germany, 45657