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Techniques for Abdominoplasty After Massive Weight Loss

Primary Purpose

Skin; Excess

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lipo-abdominoplasty
Abdominoplasty
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin; Excess focused on measuring Randomized controlled trial, Abdominoplasty, Massive weight loss, Plastic surgery, Liposuction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reconstructive Plastic Surgery, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Abdominoplasty

Lipo-abdominoplasty

Arm Description

Standard abdominoplasty

Abdominoplasty plus liposuction

Outcomes

Primary Outcome Measures

Number of and type of complications within 30 days
Number of and type of complications occurring within 30 days of surgery

Secondary Outcome Measures

Average need for analgesia in morphine equivalents
Average need for analgesia in morphine equivalents during post-operative day 1
Average score on BodyQ score
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.
Average score on aesthetic result
Average score on aesthetic result on a 1-10 scale where a lower score means worse outcome.
Average days until discharge
Average days until discharge post-operatively

Full Information

First Posted
March 10, 2021
Last Updated
March 8, 2023
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04805424
Brief Title
Techniques for Abdominoplasty After Massive Weight Loss
Official Title
Different Techniques for Abdominoplasty After Massive Weight Loss: Safety and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Karolinska University Hospital unable to support the clinical trial as anticipated.
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin; Excess
Keywords
Randomized controlled trial, Abdominoplasty, Massive weight loss, Plastic surgery, Liposuction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abdominoplasty
Arm Type
Active Comparator
Arm Description
Standard abdominoplasty
Arm Title
Lipo-abdominoplasty
Arm Type
Experimental
Arm Description
Abdominoplasty plus liposuction
Intervention Type
Procedure
Intervention Name(s)
Lipo-abdominoplasty
Intervention Description
Abdominoplasty plus liposuction
Intervention Type
Procedure
Intervention Name(s)
Abdominoplasty
Intervention Description
Abdominoplasty
Primary Outcome Measure Information:
Title
Number of and type of complications within 30 days
Description
Number of and type of complications occurring within 30 days of surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Average need for analgesia in morphine equivalents
Description
Average need for analgesia in morphine equivalents during post-operative day 1
Time Frame
Post-operative day 1
Title
Average score on BodyQ score
Description
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.
Time Frame
At baseline, at 3 months post-operatively, at 12 months post-operatively
Title
Average score on aesthetic result
Description
Average score on aesthetic result on a 1-10 scale where a lower score means worse outcome.
Time Frame
At 12 months post-operatively
Title
Average days until discharge
Description
Average days until discharge post-operatively
Time Frame
Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebba Lindqvist, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reconstructive Plastic Surgery, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Techniques for Abdominoplasty After Massive Weight Loss

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