Rectus Abdominis Plication during tummy tuck for diastasis and belly laxity
Official title: Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Run by Research Inc · NCT07805915 · Data updated 2026-11-12
This study tests a surgeon-developed technique to tighten the middle abdominal muscles during abdominoplasty in adults with diastasis recti.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Research Inc Industry-sponsored |
| Locations | 1 site (Medellín) |
| Status | Recruiting |
| Started | January 12, 2024 |
| Main results expected | September 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07805915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with rectus diastasis undergoing primary abdominoplasty and meeting ultrasound-confirmed criteria, who are weight-stable and able to attend 12-month follow-up.
✕Probably not a fit
Individuals with prior significant abdominal wall surgery, hernias requiring separate repair, pregnancy during the study, or BMI above 35 kg/m2 (unless included by protocol) may not benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-group study will apply a standardized rectus abdominis plication during primary abdominoplasty and track outcomes for one year. Ultrasound measurements of inter-rectus distance will be taken before surgery, at 3 months, and at 12 months to assess anatomical changes. Secondary outcomes include recurrence, abdominal wall function, patient satisfaction, and surgical complications to provide safety and effectiveness estimates. Data on operative variables and protocol adherence will help identify factors associated with recurrence.
Why it matters
Potential benefit: If successful, the procedure could improve abdominal wall function and appearance for people with diastasis recti undergoing abdominoplasty.
How similar studies have gone: Prior studies of rectus plication during abdominoplasty have shown variable durability; this trial seeks to provide standardized safety and one-year effectiveness data for a standardized technique.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
IQ interquirofanos
Medellín, Colombia Recruiting
Study contacts
- Principal investigator: jose D Salazar
- Study coordinator: jose D Salazar, MD, Plastic surgeon
- Email: heimdal007@gmail.com
- Phone: +57 311 6058486
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.