Stratafix Vs. Vicryl OAGB / MGB Suture Study

St. Franziskus Hospital

Status: Completed

Conditions: Anastomotic Stenosis; Morbid Obesity; Hemorrhage Postoperative; Anastomotic Leak

Treatments: Device: Vicryl; Device: Stratafix

Study type: Interventional

Funder types: Other

Identifiers

NCT04613635

20191020

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Stratafix

Experimental group

Treatment:

Device: Stratafix

Vicryl

Active Comparator group

Treatment:

Device: Vicryl