An interventional study of Investigator-Developed Rectus Abdominis Plication and Standardized Abdominal Wall Ultrasound in Diastasis Recti Abdominis and Abdominal Wall Laxity, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Research Inc · Not applicable, Interventional, and Treatment
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.
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.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants undergo abdominoplasty with linear rectus plication the standardized control; investigator-perform plication and complete one-year anatomical, functional, and safety follow-up.
Diagnostic Test: Standardized Abdominal Wall Ultrasound
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.
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.
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
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.
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.
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.
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
Plan to share: No — no contemplated in the patient informed consent
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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