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Stratafix vs. Vicryl OAGB / MGB Suture Study

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ClinicalTrials.gov Identifier: NCT04613635
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 9, 2020
Sponsor:
Collaborator:
RWTH Aachen University
Information provided by (Responsible Party):
Andreas Plamper, St. Franziskus Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Anastomotic Leak Anastomotic Stenosis Hemorrhage Postoperative Device: Stratafix Device: Vicryl Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : April 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Stratafix Device: Stratafix
Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Stratafix USP (United States Pharmacopoe) 2-0 thread
Other Name: monocrylic spiral knotless tissue control device
Active Comparator: Vicryl Device: Vicryl
Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread
Other Name: traditional polyglactin multifilament suture


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


Secondary Outcome Measures :
  1. anastomotic site perioperative morbidity [ Time Frame: 6 months ]
    Number of participants with hemorrhage, leakage or symptomatic strictures requiring further diagnostic or therapeutic measurements

  2. other anastomosis- related morbidity [ Time Frame: 6 months ]
    Number of participants with marginal ulcer or anastomotic stricture needing further diagnostic and/or interventions

  3. economical factors [ Time Frame: 6 months ]
    costs of treatment in case the above mentioned complications occur and require intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613635


Contacts
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Contact: Karl P Rheinwalt, MD +49-221-5591 ext 1128 karlpeter.rheinwalt@cellitinnen.de
Contact: Andreas Plamper, MD +49-221-5591 ext 1126 andreas.plamper@cellitinnen.de

Locations
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Germany
St. Franziskus-Hospital Recruiting
Cologne, Germany, 50825
Contact: Karl P Rheinwalt, MD    +49-221-5591 ext 1128    karlpeter.rheinwalt@cellitinnen.de   
Contact: Andreas Plamper, MD    +49-221-5591 ext 1126    andreas.plamper@cellitinnen.de   
Sponsors and Collaborators
St. Franziskus Hospital
RWTH Aachen University
More Information
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Publications of Results:

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Responsible Party: Andreas Plamper, Assistant Principal Investigator, St. Franziskus Hospital
ClinicalTrials.gov Identifier: NCT04613635    
Other Study ID Numbers: 20191020
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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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
Keywords provided by Andreas Plamper, St. Franziskus Hospital:
Mini-Gastric Bypass
One Anastomosis Gastric Bypass
Gastroenteral Anastomosis
MGB
OAGB
Additional relevant MeSH terms:
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Obesity, Morbid
Hemorrhage
Anastomotic Leak
Postoperative Hemorrhage
Pathologic Processes
Obesity
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Postoperative Complications