Not provided
Not provided
Not provided
Not provided
Not provided
Karolinska University Hospital unable to support the clinical trial as anticipated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominoplasty | Active Comparator | Standard abdominoplasty |
|
| Lipo-abdominoplasty | Experimental | Abdominoplasty plus liposuction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipo-abdominoplasty | Procedure | Abdominoplasty plus liposuction |
| |
| 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 |
| 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. |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ebba Lindqvist, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reconstructive Plastic Surgery, Karolinska University Hospital | Stockholm | 171 76 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D061645 | Abdominoplasty |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Abdominoplasty |
| Procedure |
Abdominoplasty |
|
| 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 |