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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorResearch Inc

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Investigator-Developed Rectus Abdominis Plication

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Investigator-Developed Rectus PlicationExperimental treatment 2 interventions
Group B: abdominoplasty with linear rectus plicationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.
4

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

Other outcomes

Sponsors and contacts

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