Skin; Excess Clinical Trial
Official title:
Different Techniques for Abdominoplasty After Massive Weight Loss: Safety and Outcomes
| NCT number | NCT04805424 |
| Other study ID # | 2020-06151 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2023 |
| Est. completion date | June 2025 |
| Verified date | March 2023 |
| Source | Karolinska University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2025 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Reconstructive Plastic Surgery, Karolinska University Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of and type of complications within 30 days | Number of and type of complications occurring within 30 days of surgery | 30 days | |
| Secondary | Average need for analgesia in morphine equivalents | Average need for analgesia in morphine equivalents during post-operative day 1 | Post-operative day 1 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Average days until discharge | Average days until discharge post-operatively | Days |