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

Sponsor: Research Inc • ClinicalTrials.gov ID: NCT07805915

Registry updated: 2026-10-07

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Description

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.

Interventions

Investigator-Developed Rectus Abdominis Plication (Procedure)
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.
Standardized Abdominal Wall Ultrasound (Diagnostic test)
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.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Prior major abdominal wall reconstruction or mesh repair that prevents standardized plication assessment. * Ventral or incisional hernia requiring a separate reconstructive procedure. * Pregnancy, breastfeeding, or planned pregnancy during the 12-month follow-up. * Uncontrolled systemic disease or contraindication to elective abdominoplasty. * BMI greater than 35 kg/m2 unless the final operative protocol intentionally includes this population. * Inability to obtain technically adequate baseline ultrasound measurements.

Conditions

Diastasis Recti Abdominis Abdominal Wall Laxity

Locations

IQ interquirofanos — Medellín, Colombia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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