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

NCT ID: NCT03793738

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Large Midline Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Anterior component separation

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Posterior component separation

Intervention Type PROCEDURE

Interventions

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Anterior component separation

Intervention Type PROCEDURE

Posterior component separation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zaza Demetrashvili

OTHER

Sponsor Role lead

Responsible Party

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Zaza Demetrashvili

Associate Professor, Surgery Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zaza Demetrashvili, PhD

Role: PRINCIPAL_INVESTIGATOR

Tbilisi State Medical University

Locations

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Tbilisi State Medical University

Tbilisi, , Georgia

Site Status RECRUITING

Countries

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Georgia

Central Contacts

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Zaza Demetrashvili, MD, PhD

Role: CONTACT

+995599217733

George Kenchadze, MD

Role: CONTACT

+995599351249

Facility Contacts

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Zaza Demetrashvili

Role: primary

Other Identifiers

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01004006344

Identifier Type: -

Identifier Source: org_study_id

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