search
Back to results

Abdominoplasty With Ventral Hernia Repair Versus Hernioplasty .

Primary Purpose

Abdominal Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abdominoplasty with ventral hernia repair versus ventral hernioplasty.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Hernia focused on measuring Ventral hernia, Abdominoplasty, Hernioplasty

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Concomitant abdominoplasty with ventral hernia repair .

    Ventral Hernioplasty

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Recurrence rate
    Comparison between the two procedures regarding the rate of recurrence within the two patients groups.
    Umbilical ischaemic changes
    Detection of post operative ishaemia and necrosis of umbilicus as a known complication of abdominoplasty procedure.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    March 20, 2023
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05792839
    Brief Title
    Abdominoplasty With Ventral Hernia Repair Versus Hernioplasty .
    Official Title
    Concomitant Abdominoplasty With Ventral Hernia Repair Versus Ventral Hernioplasty . A Randomized Comparative Prospective Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Hernia
    Keywords
    Ventral hernia, Abdominoplasty, Hernioplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Repair of ventral hernia with hernioplasty or abdominoplasty.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Concomitant abdominoplasty with ventral hernia repair .
    Arm Type
    Active Comparator
    Arm Description
    We do abdominoplasty with concomitant repair of the hernial defect and abdominal wall muscles in the same setting.
    Arm Title
    Ventral Hernioplasty
    Arm Type
    Active Comparator
    Arm Description
    We do hernioplasty with mesh placement for a surgical treatment for ventral hernia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Abdominoplasty with ventral hernia repair versus ventral hernioplasty.
    Intervention Description
    We do surgical treatment for ventral hernia in the form of hernioplasty with surgical mesh placement or by means of abdominoplasty surgical technique.
    Primary Outcome Measure Information:
    Title
    Recurrence rate
    Description
    Comparison between the two procedures regarding the rate of recurrence within the two patients groups.
    Time Frame
    Baseline
    Title
    Umbilical ischaemic changes
    Description
    Detection of post operative ishaemia and necrosis of umbilicus as a known complication of abdominoplasty procedure.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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: -

    12. IPD Sharing Statement

    Learn more about this trial

    Abdominoplasty With Ventral Hernia Repair Versus Hernioplasty .

    We'll reach out to this number within 24 hrs