About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Investigator-Developed Rectus Abdominis Plication
Procedure/SurgeryA 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 testInter-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.
Treatment groups
Trial 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.
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.
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.
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.
Incidence of Standard Abdominoplasty Complications
Proportion with seroma requiring aspiration, hematoma, surgical-site infection, wound dehiscence, skin necrosis, venous thromboembolism, or unplanned reoperation.
Sponsors and contacts
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