Stratafix Vs. Vicryl OAGB / MGB Suture Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04613635

Enrollment

100

Registered

2020-11-03

Start date

2020-11-06

Completion date

2024-04-30

Last updated

2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Anastomotic Stenosis, Hemorrhage Postoperative, Morbid Obesity

Keywords

Mini-Gastric Bypass, One Anastomosis Gastric Bypass, Gastroenteral Anastomosis, MGB, OAGB

Brief 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.

Interventions

DEVICEStratafix

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

DEVICEVicryl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026