Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

Anastomotic Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05189574
• Other study ID #: EVac-LSGL
• Status: Completed
• Start date: January 3, 2020
• Est. completion date: December 17, 2021

Study information

• Verified date: January 2022
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 17, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

Procedure:
• Endoscopic negative pressure therapy
Endoscopic placement of a sponge in/at staple line leaks under negative pressure.

Locations

Country	Name	City	State
Germany	Klinikum Vest GmbH	Recklinghausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with closure of staple line leak	Resolution of the fistula with no further need for intervention (surgical or endoscopic).	up to 16 weeks
Secondary	Number of endoscopic interventions	Number of endoscopic interventions in each patient	up to 16 weeks
Secondary	Hospital stay	Time of hospital stay for each patient	up to 24 weeks
Secondary	Mortality	Mortality rate during hospital stay	up to 24 weeks