NCT03793738

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

6.5 years

First QC Date

December 27, 2018

Last Update Submit

October 18, 2022

Conditions

Large Midline Ventral Hernia

Keywords

anterior component separation, TAR

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence

    Develop of ventral hernia recurrence

    during 3 year after surgery

Secondary Outcomes (1)

  • Wound complications

    30 day after surgery

Study Arms (2)

anterior component separation

ACTIVE COMPARATOR

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

posterior component separation

ACTIVE COMPARATOR

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

Interventions

Anterior component separationPROCEDURE
anterior component separation
Posterior component separationPROCEDURE
posterior component separation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tbilisi State Medical University

Tbilisi, 0186, Georgia

RECRUITING

MeSH Terms

Conditions

Absent radii and thrombocytopenia

Study Officials

  • Zaza Demetrashvili, PhD

    Tbilisi State Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaza Demetrashvili, MD, PhD

CONTACT

+995599217733zdemetr@yahoo.com

George Kenchadze, MD

CONTACT

+995599351249gugaken@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Surgery Department

Study Record Dates

First Submitted

December 27, 2018

First Posted

January 4, 2019

Study Start

December 1, 2016

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

GE(1)