Techniques for Abdominoplasty After Massive Weight Loss

Not Applicable

Withdrawn

• Conditions: Skin; Excess
• Interventions: Procedure: Lipo-abdominoplasty; Procedure: Abdominoplasty

• Registration Number: NCT04805424
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-18
• Study Start: 2023-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Primary Completion: 2025-01
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipo-abdominoplasty	Lipo-abdominoplasty	Abdominoplasty plus liposuction
Abdominoplasty	Abdominoplasty	Standard abdominoplasty

Primary Outcome Measures

Name	Time	Method
Number of and type of complications within 30 days	30 days	Number of and type of complications occurring within 30 days of surgery

Secondary Outcome Measures

Name	Time	Method
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
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 need for analgesia in morphine equivalents	Post-operative day 1	Average need for analgesia in morphine equivalents during post-operative day 1

Trial Locations

Locations (1)

Reconstructive Plastic Surgery, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden