Back to resultsStratafix vs. Vicryl OAGB / MGB Suture Study
Primary Purpose
Morbid Obesity, Anastomotic Leak, Anastomotic Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Stratafix
Vicryl
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Mini-Gastric Bypass, One Anastomosis Gastric Bypass, Gastroenteral Anastomosis, MGB, OAGB
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
Sites / Locations
- St. Franziskus-HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stratafix
Vicryl
Arm Description
Outcomes
Primary Outcome Measures
Closure of gastrojejunostomy
time needed to perform this specific surgical step, i.e. the ventral defect closure of the (otherwise stapled) gastrojejunostomy
Secondary Outcome Measures
anastomotic site perioperative morbidity
Number of participants with hemorrhage, leakage or symptomatic strictures requiring further diagnostic or therapeutic measurements
other anastomosis- related morbidity
Number of participants with marginal ulcer or anastomotic stricture needing further diagnostic and/or interventions
economical factors
costs of treatment in case the above mentioned complications occur and require intervention
Full Information
NCT ID
NCT04613635
First Posted
October 21, 2020
Last Updated
October 3, 2023
Sponsor
St. Franziskus Hospital
Collaborators
RWTH Aachen University
1. Study Identification
Unique Protocol Identification Number
NCT04613635
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
November 5, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Franziskus Hospital
Collaborators
RWTH Aachen University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Anastomotic Leak, Anastomotic Stenosis, Hemorrhage Postoperative
Keywords
Mini-Gastric Bypass, One Anastomosis Gastric Bypass, Gastroenteral Anastomosis, MGB, OAGB
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stratafix
Arm Type
Experimental
Arm Title
Vicryl
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Stratafix
Other Intervention Name(s)
monocrylic spiral knotless tissue control device
Intervention Description
Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Stratafix USP (United States Pharmacopoe) 2-0 thread
Intervention Type
Device
Intervention Name(s)
Vicryl
Other Intervention Name(s)
traditional polyglactin multifilament suture
Intervention Description
Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread
Primary Outcome Measure Information:
Title
Closure of gastrojejunostomy
Description
time needed to perform this specific surgical step, i.e. the ventral defect closure of the (otherwise stapled) gastrojejunostomy
Time Frame
The assessment of this surgical step will be completed during the operation.
Secondary Outcome Measure Information:
Title
anastomotic site perioperative morbidity
Description
Number of participants with hemorrhage, leakage or symptomatic strictures requiring further diagnostic or therapeutic measurements
Time Frame
6 months
Title
other anastomosis- related morbidity
Description
Number of participants with marginal ulcer or anastomotic stricture needing further diagnostic and/or interventions
Time Frame
6 months
Title
economical factors
Description
costs of treatment in case the above mentioned complications occur and require intervention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl P Rheinwalt, MD
Phone
+49-221-5591
Ext
1128
Email
karlpeter.rheinwalt@cellitinnen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Plamper, MD
Phone
+49-221-5591
Ext
1126
Email
andreas.plamper@cellitinnen.de
Facility Information:
Facility Name
St. Franziskus-Hospital
City
Cologne
ZIP/Postal Code
50825
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl P Rheinwalt, MD
Phone
+49-221-5591
Ext
1128
Email
karlpeter.rheinwalt@cellitinnen.de
First Name & Middle Initial & Last Name & Degree
Andreas Plamper, MD
Phone
+49-221-5591
Ext
1126
Email
andreas.plamper@cellitinnen.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
23011462
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.
Results Reference
result
PubMed Identifier
16259892
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.
Results Reference
result
PubMed Identifier
24682767
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.
Results Reference
result
PubMed Identifier
25585612
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. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z.
Results Reference
result
PubMed Identifier
22411569
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.
Results Reference
result
PubMed Identifier
23982648
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.
Results Reference
result
PubMed Identifier
28303503
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.
Results Reference
result
PubMed Identifier
27783366
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.
Results Reference
result
PubMed Identifier
18193178
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.
Results Reference
result
PubMed Identifier
12194550
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.
Results Reference
result
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Stratafix vs. Vicryl OAGB / MGB Suture Study
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