Stratafix vs. Vicryl OAGB / MGB Suture Study

St. Franziskus Hospital100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Morbid Obesity Anastomotic Leak Anastomotic Stenosis Hemorrhage Postoperative

Interventions

StratafixDEVICE

Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Stratafix USP (United States Pharmacopoe) 2-0 thread

VicrylDEVICE

Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Franziskus-Hospital

Cologne, Germany

Outcomes

Primary Outcomes

Closure of gastrojejunostomy

time needed to perform this specific surgical step, i.e. the ventral defect closure of the (otherwise stapled) gastrojejunostomy

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

Secondary Outcomes

anastomotic site perioperative morbidity

Number of participants with hemorrhage, leakage or symptomatic strictures requiring further diagnostic or therapeutic measurements

Time frame: 6 months

other anastomosis- related morbidity

Number of participants with marginal ulcer or anastomotic stricture needing further diagnostic and/or interventions

Time frame: 6 months

economical factors

costs of treatment in case the above mentioned complications occur and require intervention

Time frame: 6 months

Data from ClinicalTrials.gov

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