Techniques for Abdominoplasty After Massive Weight Loss

Study Overview
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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.

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

Conditions
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Skin; Excess

Intervention / Treatment
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* Procedure: Lipo-abdominoplasty
* Procedure: Abdominoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abdominoplasty<br>Standard abdominoplasty | Procedure: Abdominoplasty<br>* Abdominoplasty<br>|
| Experimental: Lipo-abdominoplasty<br>Abdominoplasty plus liposuction | Procedure: Lipo-abdominoplasty<br>* Abdominoplasty plus liposuction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of and type of complications within 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 | Average need for analgesia in morphine equivalents during post-operative day 1 | 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. | At baseline, at 3 months post-operatively, at 12 months post-operatively | 
| Average score on aesthetic result | 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 | Average days until discharge post-operatively | Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Abdominoplasty, Massive weight loss, Plastic surgery, Liposuction