Stratafix vs. Vicryl OAGB / MGB Suture Study

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of 2 Suture Materials for Closure of Ventral Defect at the Gastrojejunostomy in One-Anastomosis-Gastric Bypass / Mini-Gastric Bypass (OAGB / MGB): a Randomized Short Term Study With Monocrylic Spiral Knotless Tissue Control Device vs. Traditional Polyglactin Multifilament Suture

Conditions
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Morbid Obesity, Anastomotic Leak, Anastomotic Stenosis, Hemorrhage Postoperative

Intervention / Treatment
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* Device: Stratafix
* Device: Vicryl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stratafix<br> | Device: Stratafix<br>* Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Stratafix USP (United States Pharmacopoe) 2-0 thread<br>* Other names: monocrylic spiral knotless tissue control device;|
| Active Comparator: Vicryl<br> | Device: Vicryl<br>* Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread<br>* Other names: traditional polyglactin multifilament suture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of gastrojejunostomy | time needed to perform this specific surgical step, i.e. the ventral defect closure of the (otherwise stapled) gastrojejunostomy | The assessment of this surgical step will be completed during the operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic site perioperative morbidity | Number of participants with hemorrhage, leakage or symptomatic strictures requiring further diagnostic or therapeutic measurements | 6 months | 
| other anastomosis- related morbidity | Number of participants with marginal ulcer or anastomotic stricture needing further diagnostic and/or interventions | 6 months | 
| economical factors | costs of treatment in case the above mentioned complications occur and require intervention | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mini-Gastric Bypass, One Anastomosis Gastric Bypass, Gastroenteral Anastomosis, MGB, OAGB