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

Research Inc100 enrolled

Overview

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.

Adults undergoing primary abdominoplasty with rectus diastasis will receive a standardized plication described in a locked operative manual. Baseline and postoperative ultrasound will measure the inter-rectus distance at three fixed abdominal levels. Operative variables and protocol adherence will be recorded. Follow-up visits through month 12 will assess anatomical durability, recurrence, abdominal wall function, patient-reported satisfaction, and complications. The study is designed to generate reproducible one-year safety and effectiveness estimates and to identify factors associated with recurrence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Diastasis Recti Abdominis Abdominal Wall Laxity

Interventions

Investigator-Developed Rectus Abdominis PlicationPROCEDURE

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 UltrasoundDIAGNOSTIC_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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Mean waist perimeter

waist perimeter in cm will be measured by a meter at fixed supraumbilical levels. Change is 12-month minus baseline distance; a more negative value indicates greater narrowing.

Time frame: Baseline and postoperative month 12. 12 months

Secondary Outcomes

Incidence of Plication-Related Major Complications

Proportion of participants with abdominal compartment symptoms requiring intervention, plication disruption, symptomatic recurrence, reoperation, thromboembolic event, respiratory compromise attributed to increased abdominal pressure, or other serious event adjudicated as related to plication.

Time frame: From surgery through postoperative month 12.

Change in Abdominal Wall Physical Function

Change in the selected validated abdominal/core function instrument or BODY-Q Physical Function score. The final instrument and scoring rules will be locked before enrollment.

Time frame: Baseline, postoperative month 3, and postoperative month 12.

Change in BODY-Q Abdomen Satisfaction Score

Rasch-transformed 0-to-100 BODY-Q Abdomen score; higher values indicate greater satisfaction with abdominal appearance. Use requires the appropriate license and authorized translation.

Time frame: Baseline, postoperative month 6, and postoperative month 12.

Incidence of Standard Abdominoplasty Complications

Proportion with seroma requiring aspiration, hematoma, surgical-site infection, wound dehiscence, skin necrosis, venous thromboembolism, or unplanned reoperation.

Time frame: From surgery through postoperative day 30. 30 days