Abdominal Wall Laxity, Diastasis Recti Abdominis
Conditions
Keywords
Abdominoplasty, Rectus Abdominis Plication, Diastasis Recti, Ultrasound, Abdominal Wall Function, Recurrence
Brief 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.
Detailed description
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.
Interventions
PROCEDUREInvestigator-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_TESTStandardized 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.
Sponsors
Research Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean waist perimeter | Baseline and postoperative month 12. 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Plication-Related Major Complications | From surgery through postoperative month 12. | 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 | Baseline, postoperative month 3, and postoperative month 12. | 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 | Baseline, postoperative month 6, and postoperative month 12. | 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 | From surgery through postoperative day 30. 30 days | Proportion with seroma requiring aspiration, hematoma, surgical-site infection, wound dehiscence, skin necrosis, venous thromboembolism, or unplanned reoperation. |
Countries
Colombia
Contacts
CONTACTjose D Salazar, MD, Plastic surgeon
PRINCIPAL_INVESTIGATORjose D Salazar
Outcome results
None listed