CompletedNot Applicable

Stratafix vs. Vicryl OAGB / MGB Suture Study

Germany100 participantsStarted 2020-11-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Closure of gastrojejunostomy

Timeframe: The assessment of this surgical step will be completed during the operation.

Trial details

NCT IDNCT04613635

SponsorSt. Franziskus Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-27

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