Techniques for Abdominoplasty After Massive Weight Loss

March 8, 2023 updated by: Ebba Lindqvist, Karolinska University Hospital

Different Techniques for Abdominoplasty After Massive Weight Loss: Safety and Outcomes

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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 Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Reconstructive Plastic Surgery, Karolinska University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

This study is open only to individuals who are residents in Sweden and qualify for government-funded, inpatient, non-emergency health care within the Stockholm Region.

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abdominoplasty
Standard abdominoplasty
Procedure: Abdominoplasty
Abdominoplasty
Experimental: Lipo-abdominoplasty
Abdominoplasty plus liposuction
Procedure: Lipo-abdominoplasty
Abdominoplasty plus liposuction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of and type of complications within 30 days
Time Frame: 30 days
Number of and type of complications occurring within 30 days of surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average need for analgesia in morphine equivalents
Time Frame: Post-operative day 1
Average need for analgesia in morphine equivalents during post-operative day 1
Post-operative day 1
Average score on BodyQ score
Time Frame: At baseline, at 3 months post-operatively, at 12 months post-operatively
Average score on BodyQ score including subscales. BodyQ is developed and owned by Memorial Sloan Kettering Cancer Center. The BODY-Q is composed of 27 independently functioning scales that measure 3 overarching constructs Appearance, Quality of Life and Experience of Care. Scales are translated to a 0-100 score where a lower score means worse outcome.
At baseline, at 3 months post-operatively, at 12 months post-operatively
Average score on aesthetic result
Time Frame: At 12 months post-operatively
Average score on aesthetic result on a 1-10 scale where a lower score means worse outcome.
At 12 months post-operatively
Average days until discharge
Time Frame: Days
Average days until discharge post-operatively
Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

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 (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-06151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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