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RECRUITING
NCT07805915
NA

Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty

Sponsor: Research Inc

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-01-12

Completion Date

2026-12-01

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

PROCEDURE

Investigator-Developed Rectus Abdominis Plication

A standardized plication is performed during abdominoplasty. The locked operative appendix will specify patient position, exposure, cranial and caudal limits, suture material, number of layers, stitch configuration, target tension, intraoperative measurements, and management of associated hernia if permitted. Linked arm/group(s): Investigator-Developed Rectus Plication.

DIAGNOSTIC_TEST

Standardized Abdominal Wall Ultrasound

Inter-rectus distance will be measured at fixed levels during a standardized respiratory phase and abdominal muscle state. Three measurements per level will be averaged by a trained assessor. Linked arm/group(s): Investigator-Developed Rectus Plication.

Locations (1)

IQ interquirofanos

Medellín, Colombia