Lipoabdominoplasty With Anatomic Definition Versus Traditional Abdominoplasty

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05361525

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A tummy tuck also known as abdominoplasty is a cosmetic surgical procedure to improve the shape and appearance of the abdomen.

Condition or Disease	Intervention/Treatment	Phase
Abdomen Enlarged	Procedure: modified saldhana's technique Procedure: Traditional abdominoplasty	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Lipoabdominoplasty With Anatomic Definition Versus Traditional Abdominoplasty

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Aesthetically [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

Secondary Outcome Measures

complications [up to 2 weeks post operatively]
the usual complications of abdominoplasty

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Salah El Din Mohamed Hassan, principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05361525

Other Study ID Numbers:

Lipoabdominoplasty

First Posted:

May 4, 2022

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 10, 2022