NCT07590492

Brief Summary

This study evaluates the safety and outcomes of combining liposuction with varying degrees of abdominal flap undermining during abdominoplasty. Patients were randomly anssigned into three groups based on the extent of undermining and use of liposuction. Outcomes assessed included complication rates, horizontal laxity, and aesthetic results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

May 7, 2026

Last Update Submit

May 12, 2026

Conditions

Abdominal Wall LaxityAbdominal LipodystrophyAbdominal Wall Viability

Keywords

AbdominoplastyLiposuctionUndermining

Outcome Measures

Primary Outcomes (2)

  • Aesthetic outcome

    The postoperative aesthetic outcome was assessed using four predefined criteria by three independent surgeons in a double-blinded fashion. Each patient was assigned a postoperative score, with 1 representing the poorest outcome and 5 the best outcome. The mean score of all reviewers was then calculated for each case. These criteria included waist contour, residual adiposity (central), skin flaccidity, and the overall aesthetic appearance.

    6 months postoperatively

  • Postoperative complication rate (e.g., seroma, necrosis, infection)

    Within 6 months postoperatively

Secondary Outcomes (3)

  • Horizontal laxity

    6 months postoperatively

  • Change in BMI

    6 months postoperatively

  • Epigastric pinch

    6 months postoperatively

Study Arms (3)

Group A: limited undermining + liposuction

EXPERIMENTAL
Procedure: LiposuctionProcedure: Limited undermining

Group B: Wide undermining without liposuction

EXPERIMENTAL
Procedure: Wide undermining

Group C: Wide undermining + liposuction

EXPERIMENTAL
Procedure: LiposuctionProcedure: Wide undermining

Interventions

LiposuctionPROCEDURE

Liposuction of the abdominal flap

Group A: limited undermining + liposuctionGroup C: Wide undermining + liposuction
Wide underminingPROCEDURE

Wide undermining of the abdominal flap

Group B: Wide undermining without liposuctionGroup C: Wide undermining + liposuction
Limited underminingPROCEDURE

Limited undermining of the abdominal flap

Group A: limited undermining + liposuction

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients undergoing
  • Patients fit for elective surgery
  • BMI less than 35 kg/m2

You may not qualify if:

  • Significant uncontrolled comorbidities
  • Previous major abdominal surgery affecting flap vascularity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of plastic surgery

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 15, 2026

Study Start

July 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations

EG(1)