Skin; Excess
Conditions
Keywords
Randomized controlled trial, Abdominoplasty, Massive weight loss, Plastic surgery, Liposuction
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.
Interventions
PROCEDURELipo-abdominoplasty
Abdominoplasty plus liposuction
PROCEDUREAbdominoplasty
Abdominoplasty
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of and type of complications within 30 days | 30 days | Number of and type of complications occurring within 30 days of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average need for analgesia in morphine equivalents | Post-operative day 1 | Average need for analgesia in morphine equivalents during post-operative day 1 |
| Average score on BodyQ score | 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. |
| Average score on aesthetic result | At 12 months post-operatively | Average score on aesthetic result on a 1-10 scale where a lower score means worse outcome. |
| Average days until discharge | Days | Average days until discharge post-operatively |
Countries
Sweden
Outcome results
None listed