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Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

R

Ruhr University of Bochum

Status

Completed

Conditions

Anastomotic Leak

Treatments

Procedure: Endoscopic negative pressure therapy

Study type

Observational

Funder types

Other

Identifiers

NCT05189574
EVac-LSGL

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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