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

RecruitingNAAges 18 Years - anyAllResearch Inc
NCT07805915 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Investigator-Developed Rectus Abdominis Plication
  • Standardized Abdominal Wall Ultrasound
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Where

1 site
IQ interquirofanos
Medellín, Colombia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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