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

NCT07805915 | Recruiting

• 1 other identifier: 011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastasis Recti Abdominis; Abdominal Wall Laxity

Keywords

Abdominoplasty; Rectus Abdominis Plication; Diastasis Recti; Ultrasound; Abdominal Wall Function; Recurrence

Outcome Measures

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.

  Baseline and postoperative month 12. 12 months

Secondary Outcomes (4)

• Incidence of Plication-Related Major Complications

  From surgery through postoperative month 12.

• Change in Abdominal Wall Physical Function

  Baseline, postoperative month 3, and postoperative month 12.

• Change in BODY-Q Abdomen Satisfaction Score

  Baseline, postoperative month 6, and postoperative month 12.

• Incidence of Standard Abdominoplasty Complications

  From surgery through postoperative day 30. 30 days

Study Arms (2)

Investigator-Developed Rectus Plication

EXPERIMENTAL

Participants undergo abdominoplasty with the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.

Procedure: Investigator-Developed Rectus Abdominis Plication; Diagnostic Test: Standardized Abdominal Wall Ultrasound

abdominoplasty without plication

ACTIVE COMPARATOR

Participants undergo abdominoplasty without the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.

Diagnostic Test: Standardized Abdominal Wall Ultrasound

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.

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.

Investigator-Developed Rectus Plication; abdominoplasty without plication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

IQ interquirofanos

Medellín, Colombia

RECRUITING

Related Publications (6)

• Amro C, Ryan IA, Jog A, Broach RB, Fischer JP, Altieri MS, Azoury SC. Outcomes of Abdominal Contouring in Patients with and without Weight Loss Surgery: A Propensity-Matched Comparison Study. Plast Reconstr Surg. 2026 Mar 1;157(3):464-473. doi: 10.1097/PRS.0000000000012384. Epub 2025 Aug 13.

  PMID: 40801412 BACKGROUND

• Swanson E. Abdominal Fascial Plication and the Risk of Venous Thromboembolism in Abdominoplasty Patients: A Systematic Review of the Literature. Ann Plast Surg. 2025 Mar 1;94(3):378-383. doi: 10.1097/SAP.0000000000004149. Epub 2024 Nov 6.

  PMID: 39774064 BACKGROUND

• Restifo RJ. An In-Depth Analysis of 1370 Consecutive Abdominoplasties: Fascial Plication Increases Risk of Venous Thromboembolism, and Scoring for Plication Improves the Caprini Risk Assessment Model. Aesthet Surg J. 2024 Nov 15;44(12):NP870-NP882. doi: 10.1093/asj/sjae139.

  PMID: 38967610 BACKGROUND

• Marchica P, Costa AL, Brambullo T, Marini M, Masciopinto G, Gardener C, Grigatti M, Bassetto F, Vindigni V. Retrospective Analysis of Predictive Factors for Complications in Abdominoplasty in Massive Weight Loss Patients. Aesthetic Plast Surg. 2023 Aug;47(4):1447-1458. doi: 10.1007/s00266-022-03235-5. Epub 2023 Jan 6.

  PMID: 36609741 BACKGROUND

• Staalesen T, Olsen MF, Elander A. The Effect of Abdominoplasty and Outcome of Rectus Fascia Plication on Health-Related Quality of Life in Post-Bariatric Surgery Patients. Plast Reconstr Surg. 2015 Dec;136(6):750e-761e. doi: 10.1097/PRS.0000000000001772.

  PMID: 26595030 BACKGROUND

• Wilting R, Lier B, de Vries CE, Dalaei F, Poulsen L, Luketina R, Repo JP, Paul M, Hoogbergen M; BODY-Q Network. Health-Related Quality-of-Life Effects of Rectus Repair during Body Contouring Surgery in Postbariatric Patients: A Prospective Study. Plast Reconstr Surg. 2024 Oct 1;154(4):735-745. doi: 10.1097/PRS.0000000000011168. Epub 2023 Oct 30.

  PMID: 37903329 BACKGROUND

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jose D Salazar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jose D Salazar, MD, Plastic surgeon

CONTACT

+57 311 6058486; heimdal007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: January 12, 2024
• Primary Completion: September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)