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Abdominal HerniaNCT05792839

Abdominoplasty with Ventral Hernia Repair Versus Hernioplasty .

A study testing Abdominoplasty with ventral hernia repair versus ventral hernioplasty. in people with Abdominal Hernia, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 20 to 60 years, women only
Conditions the study is for
Abdominal Hernia
What is being tested?
Abdominoplasty with ventral hernia repair versus ventral hernioplasty.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 1 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with age more than 20 years and less than 60 years old.
  • Female patients.
  • Patients having ventral hernias with BM more than 25 kg/m2. Patients with floppy abdomen Patients with divercation of recti Patients with an (ASA) classification of 3 or less with no history of DM or other major comorbidities as cardiopulmonary, hepatic, or renal impairment.Exclusion Criteria:
  • -

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mark Natey Abdo, Master degree contact

+201205913392

Markabdo309@gmail.com

Miar Adel Fransis, Master degree contact

+01205913392

Miaradel186@gmail.com

About this study

Official title: Concomitant Abdominoplasty with Ventral Hernia Repair Versus Ventral Hernioplasty . a Randomized Comparative Prospective Study.

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

Read the detailed description

Ventral hernias are very common and do present a challenge because of the risk of recurrence.

Ventral hernias of the abdomen are defined as a non-inguinal, nonhiatal defect in the fascia of the abdominal wall. Annually, there are about 350,000 ventral hernia operations. The repair of these abdominal wall defects is a common surgery performed by general surgeons. Surgery is typically recommended for individuals with acceptable operative risk, symptomatic hernias, or those at elevated risk of developing complications from a hernia. They can affect an individual's quality of life and can lead to hospitalizations and even death in some cases.[1][2][3] Common causes of acquired ventral hernias include previous surgery causing an incisional hernia, trauma, and repetitive stress on naturally weak points of the abdominal wall. These naturally occurring weak points in the abdominal wall include the umbilicus, semilunar line, ostomy sites, bilateral inguinal regions, and esophageal hiatus. Obesity is a large component of hernias as well because it stretches the fascia of the abdomen causing it to weaken. Specifically, the action of repetitive weight gain and loss leads to weakening.[4] Reported recurrence rates after VHR in the literature vary widely and range from 2.7% to 20% for primary ventral hernia (umbilical and epigastric) to 32-37% for incisional hernia repairs, depending on the series in question. (5) Abdominoplasty can be performed in combination with hernia repair in patients with ventral hernias, especially when associated with large midline ventral hernias, diastasis of recti and the associated laxity and abdominal shape deformity, represent aesthetic and functional problems for the patients. So, the surgical treatment of both pathologies at the same time is highly recommended if the patient's general condition permits. This can be achieved by a comprehensive technique incorporating abdominoplasty performed by a transverse lower abdominal incision into any of the hernia repair techniques.(6) The procedure continues to become increasingly popular, and this is attributed to the increasing rates of obesity and subsequent use of weight loss surgery

Aim(s) of the Research (50 words max):

Is to compare the outcome and efficacy of the combined procedure of (abdominoplasty and hernioplasty) to hernioplasty alone according to rate of post operative recurrence of hernia .

Being tested
Abdominoplasty with ventral hernia repair versus ventral hernioplasty.
Keywords
Ventral hernia, Abdominoplasty, Hernioplasty
Medical subject headings
Hernia, Abdominal, Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominoplasty with ventral hernia repair versus ventral hernioplasty.Procedure or surgery

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

Study groups in NCT05792839
Study groupRoleWhat they receive
Concomitant abdominoplasty with ventral hernia repair .Active comparatorWe do abdominoplasty with concomitant repair of the hernial defect and abdominal wall muscles in the same setting.
Receives: Procedure: Abdominoplasty with ventral hernia repair versus ventral hernioplasty.
Ventral HernioplastyActive comparatorWe do hernioplasty with mesh placement for a surgical treatment for ventral hernia.
Receives: Procedure: Abdominoplasty with ventral hernia repair versus ventral hernioplasty.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence rate

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

    Measured: Baseline

  2. Umbilical ischaemic changes

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2023
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Repair of ventral hernia with hernioplasty or abdominoplasty.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05792839
Sponsor's protocol ID
Abdominoplasty & hernia
Status last verified
Dec 2024
First submitted
20 Mar 2023
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Abdominoplasty with ventral hernia repair versus ventral hernioplasty. in people with Abdominal Hernia, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mark Natey Abdo, Master degree (+201205913392, Markabdo309@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

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