NCT05792839

Brief Summary

Comparison between hernioplasty alone versus concomitant abdominoplasty with ventral hernia repair regarding efficacy and post-operative recurrence of hernia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

Same day

First QC Date

March 20, 2023

Last Update Submit

December 15, 2024

Conditions

Keywords

Ventral herniaAbdominoplastyHernioplasty

Outcome Measures

Primary Outcomes (2)

  • Recurrence rate

    Comparison between the two procedures regarding the rate of recurrence within the two patients groups.

    Baseline

  • Umbilical ischaemic changes

    Detection of post operative ishaemia and necrosis of umbilicus as a known complication of abdominoplasty procedure.

    Baseline

Study Arms (2)

Concomitant abdominoplasty with ventral hernia repair .

ACTIVE COMPARATOR

We do abdominoplasty with concomitant repair of the hernial defect and abdominal wall muscles in the same setting.

Procedure: Abdominoplasty with ventral hernia repair versus ventral hernioplasty.

Ventral Hernioplasty

ACTIVE COMPARATOR

We do hernioplasty with mesh placement for a surgical treatment for ventral hernia.

Procedure: Abdominoplasty with ventral hernia repair versus ventral hernioplasty.

Interventions

We do surgical treatment for ventral hernia in the form of hernioplasty with surgical mesh placement or by means of abdominoplasty surgical technique.

Concomitant abdominoplasty with ventral hernia repair .Ventral Hernioplasty

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with age more than 20 years and less than 60 years old.
  • Female patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, AbdominalHernia, Ventral

Interventions

Abdominoplasty

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Mark Natey Abdo, Master degree

CONTACT

Miar Adel Fransis, Master degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Repair of ventral hernia with hernioplasty or abdominoplasty.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at general and laparoscopic surgery department , assiut university hospital.

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 31, 2023

Study Start

March 1, 2025

Primary Completion

March 1, 2025

Study Completion

October 1, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share