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

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 Overview

• Status: Completed
• Conditions: Anastomotic Leak; Morbid Obesity; Anastomotic Stenosis; Hemorrhage Postoperative
• Intervention / Treatment: Device: Stratafix; Device: Vicryl

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50825
    • St. Franziskus-Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vicryl	Device: Vicryl; Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread; Other Names: traditional polyglactin multifilament suture
Experimental: Stratafix	Device: Stratafix; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Franziskus Hospital
• Collaborators: RWTH Aachen University

Publications and helpful links

General Publications

• Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.
• Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
• Noun R, Skaff J, Riachi E, Daher R, Antoun NA, Nasr M. One thousand consecutive mini-gastric bypass: short- and long-term outcome. Obes Surg. 2012 May;22(5):697-703. doi: 10.1007/s11695-012-0618-z.
• Skroubis G, Sakellaropoulos G, Pouggouras K, Mead N, Nikiforidis G, Kalfarentzos F. Comparison of nutritional deficiencies after Roux-en-Y gastric bypass and after biliopancreatic diversion with Roux-en-Y gastric bypass. Obes Surg. 2002 Aug;12(4):551-8. doi: 10.1381/096089202762252334.
• Kular KS, Manchanda N, Rutledge R. A 6-year experience with 1,054 mini-gastric bypasses-first study from Indian subcontinent. Obes Surg. 2014 Sep;24(9):1430-5. doi: 10.1007/s11695-014-1220-3.
• Chevallier JM, Arman GA, Guenzi M, Rau C, Bruzzi M, Beaupel N, Zinzindohoue F, Berger A. One thousand single anastomosis (omega loop) gastric bypasses to treat morbid obesity in a 7-year period: outcomes show few complications and good efficacy. Obes Surg. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z.
• Musella M, Susa A, Greco F, De Luca M, Manno E, Di Stefano C, Milone M, Bonfanti R, Segato G, Antonino A, Piazza L. The laparoscopic mini-gastric bypass: the Italian experience: outcomes from 974 consecutive cases in a multicenter review. Surg Endosc. 2014 Jan;28(1):156-63. doi: 10.1007/s00464-013-3141-y. Epub 2013 Aug 28.
• Taha O, Abdelaal M, Abozeid M, Askalany A, Alaa M. Outcomes of Omega Loop Gastric Bypass, 6-Years Experience of 1520 Cases. Obes Surg. 2017 Aug;27(8):1952-1960. doi: 10.1007/s11695-017-2623-8.
• Carbajo MA, Luque-de-Leon E, Jimenez JM, Ortiz-de-Solorzano J, Perez-Miranda M, Castro-Alija MJ. Laparoscopic One-Anastomosis Gastric Bypass: Technique, Results, and Long-Term Follow-Up in 1200 Patients. Obes Surg. 2017 May;27(5):1153-1167. doi: 10.1007/s11695-016-2428-1.
• Lee WJ, Wang W, Lee YC, Huang MT, Ser KH, Chen JC. Laparoscopic mini-gastric bypass: experience with tailored bypass limb according to body weight. Obes Surg. 2008 Mar;18(3):294-9. doi: 10.1007/s11695-007-9367-9. Epub 2008 Jan 12.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Mini-Gastric Bypass; One Anastomosis Gastric Bypass; OAGB; Gastroenteral Anastomosis; MGB
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid; Hemorrhage; Anastomotic Leak; Postoperative Hemorrhage
• Other Study ID Numbers: 20191020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No