Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This prospective single-group study will evaluate an investigator-developed rectus abdominis plication performed during abdominoplasty. Standardized ultrasound will measure inter-rectus distance before surgery and at 3 and 12 months. The primary outcome is change in mean inter-rectus distance at one year. Recurrence, abdominal wall function, BODY-Q satisfaction, surgical complications, and reoperation will also be assessed.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 to 65 years.
• Scheduled for primary abdominoplasty with rectus plication.
• Rectus diastasis documented clinically or by baseline ultrasound.
• Stable body weight for at least 3 months before surgery.
• Ability to complete ultrasound and clinical follow-up through 12 months.
• Written informed consent.
Locations
Other Locations
Colombia
IQ interquirofanos
RECRUITING
Medellín
Contact Information
Primary
jose D Salazar, MD, Plastic surgeon
heimdal007@gmail.com
+57 311 6058486
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 100
Treatments
Experimental: Investigator-Developed Rectus Plication
Participants undergo abdominoplasty with the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.
Active_comparator: abdominoplasty without plication
Participants undergo abdominoplasty without the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.
Related Therapeutic Areas
Sponsors
Leads: Research Inc