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

Primary Purpose

Large Midline Ventral Hernia

Status

Recruiting

Phase

Not Applicable

Locations

Georgia

Study Type

Interventional

Intervention

Anterior component separation

Posterior component separation

About this trial

This is an interventional treatment trial for Large Midline Ventral Hernia focused on measuring anterior component separation, TAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tbilisi State Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

anterior component separation

posterior component separation

Arm 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.

Outcomes

Primary Outcome Measures

Hernia recurrence

Develop of ventral hernia recurrence

Secondary Outcome Measures

Wound complications

Develop of wound complications (seroma, hematoma, surgical site infection)

Full Information

NCT ID

NCT03793738

First Posted

December 27, 2018

Last Updated

October 18, 2022

Sponsor

Zaza Demetrashvili

1. Study Identification

Unique Protocol Identification Number

NCT03793738

Brief Title

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

Official Title

Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 2016 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zaza Demetrashvili

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Large Midline Ventral Hernia

Keywords

anterior component separation, TAR

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anterior component separation

Arm Type

Active Comparator

Arm 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.

Arm Title

posterior component separation

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Anterior component separation

Intervention Type

Procedure

Intervention Name(s)

Posterior component separation

Primary Outcome Measure Information:

Title

Hernia recurrence

Description

Develop of ventral hernia recurrence

Time Frame

during 3 year after surgery

Secondary Outcome Measure Information:

Title

Wound complications

Description

Develop of wound complications (seroma, hematoma, surgical site infection)

Time Frame

30 day after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zaza Demetrashvili, MD, PhD

Phone

+995599217733

zdemetr@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

George Kenchadze, MD

Phone

+995599351249

gugaken@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zaza Demetrashvili, PhD

Organizational Affiliation

Tbilisi State Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tbilisi State Medical University

City

Tbilisi

ZIP/Postal Code

0186

Country

Georgia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zaza Demetrashvili

zdemetr@yahoo.com

First Name & Middle Initial & Last Name & Degree

Zaza Demetrashvili

12. IPD Sharing Statement

Learn more about this trial

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

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