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Stratafix vs. Vicryl OAGB / MGB Suture Study

Recruiting
18 years of age
Both
Phase N/A

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Overview

To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.

Eligibility

Inclusion Criteria:

  • adult patients selected for primary Mini-Gastric bypass to treat obesity (BMI>30)
  • laparoscopic access feasable (intention to treat laparoscopically)
  • failed conservative treatment (accepted by health insurance companies)
  • relevant co-morbidities in cases with BMI <40
  • age 18 years or elder

Exclusion Criteria:

  • severe language problems
  • revisional or redo-procedures
  • operation intended as open procedure(extensive previous surgeries),
  • operation performed under corticoid-medication
  • operation performed under full-dose anticoagulants
  • operation performed by another surgeon than one of the 3 experienced MGB-surgeons of the Department

Study details

Morbid Obesity, Anastomotic Leak, Anastomotic Stenosis, Hemorrhage Postoperative

NCT04613635

St. Franziskus Hospital

25 January 2024

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