CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Stratafix +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04613635
NCT04613635N/ACompleted
CompareCT.gov

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

St. Franziskus Hospital·interventional·Posted Nov 3, 2020·Updated Dec 17, 2024

In Brief

A clinical study evaluating Stratafix and Vicryl for Morbid Obesity and 3 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity, Anastomotic Leak, Anastomotic Stenosis, Hemorrhage Postoperative
CountriesGermany
CollaboratorsRWTH Aachen University

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 3, 2020
Enrollment StartNov 6, 2020
Primary CompletionOct 27, 2023
Study CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.7 years ago

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