Abdominoplasty With Ventral Hernia Repair Versus Hernioplasty .

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05792839

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Abdominal Hernia	Procedure: Abdominoplasty with ventral hernia repair versus ventral hernioplasty.	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Repair of ventral hernia with hernioplasty or abdominoplasty.Repair of ventral hernia with hernioplasty or abdominoplasty.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Concomitant Abdominoplasty With Ventral Hernia Repair Versus Ventral Hernioplasty . A Randomized Comparative Prospective Study.

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Concomitant abdominoplasty with ventral hernia repair . 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. We do surgical treatment for ventral hernia in the form of hernioplasty with surgical mesh placement or by means of abdominoplasty surgical technique.
Active Comparator: Ventral Hernioplasty We do hernioplasty with mesh placement for a surgical treatment for ventral hernia.	Procedure: Abdominoplasty with ventral hernia repair versus ventral hernioplasty. We do surgical treatment for ventral hernia in the form of hernioplasty with surgical mesh placement or by means of abdominoplasty surgical technique.

Arm

Intervention/Treatment

Active Comparator: Concomitant abdominoplasty with ventral hernia repair .

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.

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

Active Comparator: Ventral Hernioplasty

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

Procedure: Abdominoplasty with ventral hernia repair versus ventral hernioplasty.

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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: