Anastomotic Leak
Conditions
Keywords
staple line leak, endoscopic vacuum therapy, endoscopic negative pressure therapy, laparoscopic sleeve gastrectomy
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).
Interventions
PROCEDUREEndoscopic negative pressure therapy
Endoscopic placement of a sponge in/at staple line leaks under negative pressure.
Sponsors
Ruhr University of Bochum
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed