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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 27, 2018
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date October 19, 2022
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)		 Hernia recurrence [ Time Frame: during 3 year after surgery ]
Develop of ventral hernia recurrence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2019)		 Wound complications [ Time Frame: 30 day after surgery ]
Develop of wound complications (seroma, hematoma, surgical site infection)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias
Official Title  ICMJE Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Large Midline Ventral Hernia
Intervention  ICMJE
  • Procedure: Anterior component separation
  • Procedure: Posterior component separation
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Procedure: Posterior component separation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2019)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zaza Demetrashvili, MD, PhD +995599217733 zdemetr@yahoo.com
Contact: George Kenchadze, MD +995599351249 gugaken@yahoo.com
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03793738
Other Study ID Numbers  ICMJE 01004006344
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Zaza Demetrashvili, Tbilisi State Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zaza Demetrashvili
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zaza Demetrashvili, PhD Tbilisi State Medical University
PRS Account Tbilisi State Medical University
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP