Trials / Completed
CompletedNCT05189574
Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks
Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- Ruhr University of Bochum · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- —
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Endoscopic negative pressure therapy | Endoscopic placement of a sponge in/at staple line leaks under negative pressure. |
Timeline
- Start date
- 2020-01-03
- Primary completion
- 2021-06-30
- Completion
- 2021-12-17
- First posted
- 2022-01-12
- Last updated
- 2022-01-12
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05189574. Inclusion in this directory is not an endorsement.