Techniques for Abdominoplasty After Massive Weight Loss

NCT04805424 | Withdrawn

• 1 other identifier: 2020-06151
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin; Excess

Keywords

Randomized controlled trial; Abdominoplasty; Massive weight loss; Plastic surgery; Liposuction

Outcome Measures

Primary Outcomes (1)

• Number of and type of complications within 30 days

  Number of and type of complications occurring within 30 days of surgery

  30 days

Secondary Outcomes (4)

• Average need for analgesia in morphine equivalents

  Post-operative day 1

• Average score on BodyQ score

  At baseline, at 3 months post-operatively, at 12 months post-operatively

• Average score on aesthetic result

  At 12 months post-operatively

• Average days until discharge

  Days

Study Arms (2)

Abdominoplasty

ACTIVE COMPARATOR

Standard abdominoplasty

Procedure: Abdominoplasty

Lipo-abdominoplasty

EXPERIMENTAL

Abdominoplasty plus liposuction

Procedure: Lipo-abdominoplasty

Interventions

Lipo-abdominoplasty PROCEDURE

Abdominoplasty plus liposuction

Lipo-abdominoplasty

Abdominoplasty PROCEDURE

Abdominoplasty

Abdominoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smoking
• Ongoing infection

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Reconstructive Plastic Surgery, Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

MeSH Terms

Interventions

Abdominoplasty

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Ebba Lindqvist, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 18, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)