Lipoabdominoplasty With Anatomic Definition Versus Traditional Abdominoplasty

September 5, 2022 updated by: Mohamed Salah El Din Mohamed Hassan, Assiut University
A tummy tuck also known as abdominoplasty is a cosmetic surgical procedure to improve the shape and appearance of the abdomen.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lipoabdominoplasty guarantees a safe combination of abdominoplasty and liposuction while minimizing the risk of ischemic flap complications. This is because of the limited undermining performed and the liposuction adjunct, both of which minimize perforator injury. In the last several years, the integration of anatomic definition through the use of liposuction has further refined the procedure, led to improved results, and increased patient satisfaction. The more natural results of the anatomic abdominal definition is a next step in abdominal contour refinement.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

  • Egypt
      • Asyut, Egypt, 75555
        • Recruiting
        • Asyut University Hospital
        • Contact:
          • Mohamed Salah
          • Phone Number: 01028284928

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

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients between 25 to 60 with redundant abdominal wall.
  • BMI less than 35.

Exclusion Criteria:

  • Patients younger than 25 or older than 60.
  • BMI more than 35.
  • Hernias and scars interfering with abdominal vascularity.
  • Patients smoking or with comorbidities (DM, HTN, ...etc).
  • Patients seeking for another pregnancies.
  • Any causes that may interfere with general anaesthesia. Refusal for any part of the written conset

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lipoabdominoplasty with anatomic definition
Lipoabdominoplasty with anatomic definition without over dissection on the lateral recti region
Procedure: modified saldhana's technique
tummy tuck with anatomic definition using liposuction
Sham Comparator: traditional abdominoplasty
abdominoplasty with dissection in v- shaped pattern till coastal margin
Procedure: Traditional abdominoplasty
uses the traditional technique of abdominoplasty with liposuction with v-shaped dissection till the coastal margin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetically
Time Frame: 6 months post op
natural look, patient satisfaction on scale (Rosenberg self esteem scale, it uses scale 0-30, where score less than 15 indicate low self esteem problem) with 10 items 6 months post operative and compare it with the preoperative results of the same patient, patient sexual satisfaction after 6 months in comparison with the preoperative results, doctors opinion and natural curves at the muscle insertion sites
6 months post op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: up to 2 weeks post operatively
the usual complications of abdominoplasty
up to 2 weeks post operatively

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)

May 1, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

May 1, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Lipoabdominoplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Lipoadominoplasty with anatomin definition versus traditional abdominoplasty

IPD Sharing Time Frame

it will be available after the study is complete in approximately two years

IPD Sharing Access Criteria

access for every one

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

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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