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Withdrawn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
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
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
NCT ID
NCT04805424
First Posted
March 10, 2021
Last Updated
March 8, 2023
Sponsor
Karolinska University Hospital
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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