NCT04613635Completed
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
Source: ClinicalTrials.gov · Last updated 17 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 21 Oct 2020
- Start date
- 6 Nov 2020
- Primary completion date
- 27 Oct 2023
- Lead sponsor
- St. Franziskus Hospital
- Diseases
- Obesity
- NCT number
- NCT04613635
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 6 Nov 2020 to the primary completion date, 27 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- operation intended as open procedure(extensive previous surgeries),
- operation performed under corticoid-medication
Other
- severe language problems
- revisional or redo-procedures
- operation performed under full-dose anticoagulants
- operation performed by another surgeon than one of the 3 experienced MGB-surgeons of the Department
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Franziskus-Hospital Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.