Stratafix vs. Vicryl OAGB / MGB Suture Study

Morbid Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613635
• Other study ID #: 20191020
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: St. Franziskus Hospital
• Contact: Karl P Rheinwalt, MD
• Phone: +49-221-5591
• Email: karlpeter.rheinwalt[@]cellitinnen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Stenosis
• Hemorrhage
• Hemorrhage Postoperative
• Morbid Obesity
• Obesity, Morbid
• Postoperative Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Germany	St. Franziskus-Hospital	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
St. Franziskus Hospital	RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (10)

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/s — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 201 — View Citation

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. — View Citation

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. — View Citation

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. d — View Citation

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. — View Citation

Outcome

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