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OpenTrials
Completed

NCT Number: NCT04613635

Stratafix vs. Vicryl OAGB / MGB Suture Study

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.

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Key information

Conditions

Morbid Obesity Anastomotic Leak Anastomotic Stenosis Body Weight Hemorrhage Hemorrhage Postoperative Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Franziskus-Hospital

Cologne, 50825, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stratafix

Device

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

Other names: monocrylic spiral knotless tissue control device

Vicryl

Device

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

Other names: traditional polyglactin multifilament suture

Primary outcomes

  1. Closure of gastrojejunostomy

    Time frame: 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 outcomes

  1. anastomotic site perioperative morbidity

    Time frame: 6 months

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

  2. other anastomosis- related morbidity

    Time frame: 6 months

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

  3. economical factors

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

St. Franziskus Hospital

Other

Collaborators

  • RWTH Aachen University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Nov 3, 2020
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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