Impact of Monsplasty in Women Undergoing Abdominoplasty

December 26, 2022 updated by: Mostafa Mohamed Hassan, Assiut University

the Aesthetic and Functional Impact of Monsplasty in Women Undergoing Abdominoplasty

Evaluate The aesthetic and function satisfaction outcomes of different monsplasty surgery with or after abdominoplasty

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The high incidence of female obesity has resulted in common complaints of a large mons pubis and labia majora (outer labial lips) related to unsightly fat deposits. The mons and labia majora enlarge, protrude, descend, and hang. Even with dramatic weight loss, these areas remain descended and bulky, with excess fat and skin. The affected majora can cause difficulty with sexual intercourse and maintenance of hygiene, and result in discomfort when wearing pants and swimsuits. These unnatural .fat deposits can also severely affect self-esteem

The surgical treatment of the enlarged mons pubis and labia majora has been poorly understood and therefore often neglected. Traditionally, the mons has been treated by fat reduction, whether by liposuction or open excision, along with a pubic skin lift. However, skin elevation is usually unsatisfactory, because the mons will descend again upon standing. Many of these unsuccessful lifts present after a simultaneous abdominoplasty.

In many ways, the treatment of the mons pubis correlates with the treatment of the hidden penis in the obese or formerly obese male.1-3 Excess suprapubic skin and mons fat removal-along with tacking of the fibrofatty tissue of the pubic skin flap to the rectus fascia-are mandatory to achieve a lasting, successful mons pubis lift.4 Labia majora reduction. Depends on the surgically appropriate removal of fat and/or skin

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any adult married woman from 20 to 45 years old candidate for abdominoplasty with stable weight in last 6 months

Exclusion Criteria:

  • patients less than 20 years old and more than 45 years old
  • patients with medical conditions affecting wound healing
  • patients with skin infection in lower abdomen and pubic area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abdominoplasty with Monsplasty
Procedure: Monsplasty
liposuction assisted monsplasty
Active Comparator: Abdominoplasty without monsplasty
Procedure: Monsplasty
liposuction assisted monsplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine better result
Time Frame: 3 years
Determine which is bettereither abdominoplast with monsplasty or abdominoplasty alone by a questionnaire
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MMhassan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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