Techniques for Abdominoplasty After Massive Weight Loss

NCT ID: NCT04805424

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-06-30

Brief Summary

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Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial issues.

The investigators will conduct a randomized, controlled trial where individuals with excess skin on the abdomen will be randomized to either standard abdominoplasty or abdominoplasty in combination with liposuction. The investigators will examine the rate of complications, and the functional and aesthetical outcomes of the two methods.

Detailed Description

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Conditions

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Skin; Excess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Abdominoplasty

Standard abdominoplasty

Group Type ACTIVE_COMPARATOR

Abdominoplasty

Intervention Type PROCEDURE

Abdominoplasty

Lipo-abdominoplasty

Abdominoplasty plus liposuction

Group Type EXPERIMENTAL

Lipo-abdominoplasty

Intervention Type PROCEDURE

Abdominoplasty plus liposuction

Interventions

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Lipo-abdominoplasty

Abdominoplasty plus liposuction

Intervention Type PROCEDURE

Abdominoplasty

Abdominoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \< 30
* Stable BMI for \>= 6 months
* \>= 24 months since bariatric surgery, if applicable
* Skin fold of \>= 5 cm
* Functional and/or psychosocial issues due to abdominal skin excess

Exclusion Criteria

* Smoking
* Ongoing infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ebba Lindqvist

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebba Lindqvist, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Reconstructive Plastic Surgery, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2020-06151

Identifier Type: -

Identifier Source: org_study_id

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