Stratafix Vs. Vicryl OAGB / MGB Suture Study

NCT04613635 | Completed

• 1 other identifier: 20191020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity; Anastomotic Leak; Anastomotic Stenosis; Hemorrhage Postoperative

Keywords

Mini-Gastric Bypass; One Anastomosis Gastric Bypass; Gastroenteral Anastomosis; MGB; OAGB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• anastomotic site perioperative morbidity

  6 months

• other anastomosis- related morbidity

  6 months

• economical factors

  6 months

Study Arms (2)

Stratafix

EXPERIMENTAL

Device: Stratafix

Vicryl

ACTIVE COMPARATOR

Device: Vicryl

Interventions

Stratafix DEVICE

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

Also known as: monocrylic spiral knotless tissue control device

Stratafix

Vicryl DEVICE

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

Also known as: traditional polyglactin multifilament suture

Vicryl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Franziskus Hospital: lead
• RWTH Aachen University: collaborator

Study Sites (1)

St. Franziskus-Hospital

Cologne, 50825, Germany

Location

Related Publications (10)

• 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.

  PMID: 23011462 BACKGROUND

• 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.

  PMID: 16259892 BACKGROUND

• 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.

  PMID: 24682767 BACKGROUND

• 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.

  PMID: 25585612 BACKGROUND

• 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.

  PMID: 22411569 BACKGROUND

• 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.

  PMID: 23982648 BACKGROUND

• 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.

  PMID: 28303503 BACKGROUND

• 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.

  PMID: 27783366 BACKGROUND

• 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.

  PMID: 18193178 BACKGROUND

• 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.

  PMID: 12194550 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Anastomotic Leak; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Principal Investigator

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 3, 2020
• Study Start: November 6, 2020
• Primary Completion: October 27, 2023
• Study Completion: April 30, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

DE (1)