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Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias

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ClinicalTrials.gov Identifier: NCT03793738
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : October 19, 2022
Sponsor:
Information provided by (Responsible Party):
Zaza Demetrashvili, Tbilisi State Medical University

Study Description
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Brief Summary:
This study evaluates effect of anterior component separation and posterior component separation and transversus abdominis muscle release methods for treatment of midline ventral hernias.

Condition or disease Intervention/treatment Phase
Large Midline Ventral Hernia Procedure: Anterior component separation Procedure: Posterior component separation Not Applicable

Detailed Description:

The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.

The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the posterior sheath back to the transversus abdominal muscle and accessed the space between muscle and trasversalis fascia.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study
Actual Study Start Date : December 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: anterior component separation
The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.
 Procedure: Anterior component separation
Active Comparator: posterior component separation
The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles.
 Procedure: Posterior component separation


Outcome Measures
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Primary Outcome Measures :
  1. Hernia recurrence [ Time Frame: during 3 year after surgery ]
    Develop of ventral hernia recurrence


Secondary Outcome Measures :
  1. Wound complications [ Time Frame: 30 day after surgery ]
    Develop of wound complications (seroma, hematoma, surgical site infection)


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:

  • subject has midline ventral hernia
  • patient's approval to participate in the study

Exclusion Criteria:

  • strangulated hernia
  • patient's preference for either operative technique
  • patient's refusal to participate in the study
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): NCT03793738


Contacts
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Contact: Zaza Demetrashvili, MD, PhD +995599217733 zdemetr@yahoo.com
Contact: George Kenchadze, MD +995599351249 gugaken@yahoo.com

Locations
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Georgia
Tbilisi State Medical University Recruiting
Tbilisi, Georgia, 0186
Contact: Zaza Demetrashvili       zdemetr@yahoo.com   
Principal Investigator: Zaza Demetrashvili         
Sponsors and Collaborators
Zaza Demetrashvili
Investigators
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Principal Investigator: Zaza Demetrashvili, PhD Tbilisi State Medical University
More Information
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Responsible Party: Zaza Demetrashvili, Associate Professor, Surgery Department, Tbilisi State Medical University
ClinicalTrials.gov Identifier: NCT03793738    
Other Study ID Numbers: 01004006344
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022
Keywords provided by Zaza Demetrashvili, Tbilisi State Medical University:
anterior component separation, TAR
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal