NCT05680324

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

December 26, 2022

Last Update Submit

December 26, 2022

Conditions

Keywords

monsplasty

Outcome Measures

Primary Outcomes (1)

  • Determine better result

    Determine which is bettereither abdominoplast with monsplasty or abdominoplasty alone by a questionnaire

    3 years

Study Arms (2)

Abdominoplasty with Monsplasty

ACTIVE COMPARATOR
Procedure: Monsplasty

Abdominoplasty without monsplasty

ACTIVE COMPARATOR
Procedure: Monsplasty

Interventions

MonsplastyPROCEDURE

liposuction assisted monsplasty

Abdominoplasty with MonsplastyAbdominoplasty without monsplasty

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 11, 2023

Study Start

October 10, 2021

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

January 11, 2023

Record last verified: 2022-12

Locations