Clinical trial NCT04613635: Stratafix Vs. Vicryl OAGB / MGB Suture Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Anastomotic Leak
Anastomotic Stenosis
Hemorrhage Postoperative
Keywords: Mini-Gastric Bypass
One Anastomosis Gastric Bypass
Gastroenteral Anastomosis
MGB
OAGB
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
Collaborators: name: RWTH Aachen University
First posted: 2020-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Closure of gastrojejunostomy
timeFrame: The assessment of this surgical step will be completed during the operation.
Secondary outcomes:
measure: anastomotic site perioperative morbidity
timeFrame: 6 months
measure: other anastomosis- related morbidity
timeFrame: 6 months
measure: economical factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: St. Franziskus-Hospital
Study officials:
References:
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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.
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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. 2014 Jan;28(1):156-63. doi: 10.1007/s00464-013-3141-y. Epub 2013 Aug 28.
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.
citation: 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.
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.
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. doi: 10.1381/096089202762252334.