Diastasis Recti AbdominisNCT07805915
Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
A study testing Investigator-Developed Rectus Abdominis Plication and Standardized Abdominal Wall Ultrasound in people with Diastasis Recti Abdominis and Abdominal Wall Laxity, run by Research Inc at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastasis Recti Abdominis, Abdominal Wall Laxity
- What is being tested?
- Investigator-Developed Rectus Abdominis Plication and Standardized Abdominal Wall Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
IQ interquirofanos
Medellín
Jose D Salazar, MD, Plastic surgeon, +57 311 6058486, heimdal007@gmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Diastasis Recti Abdominis, Abdominal Wall Laxity
- Being tested
- Investigator-Developed Rectus Abdominis Plication, Standardized Abdominal Wall Ultrasound
- Keywords
- Abdominoplasty, Rectus Abdominis Plication, Diastasis Recti, Ultrasound, Abdominal Wall Function, Recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigator-Developed Rectus Abdominis PlicationProcedure or 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 UltrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Investigator-Developed Rectus Plication | Experimental | Participants undergo abdominoplasty with the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up. Receives: Procedure: Investigator-Developed Rectus Abdominis Plication; Diagnostic Test: Standardized Abdominal Wall Ultrasound |
| abdominoplasty with linear rectus plication | Active comparator | Participants undergo abdominoplasty with linear rectus plication the standardized control; investigator-perform plication and complete one-year anatomical, functional, and safety follow-up. Receives: Diagnostic Test: Standardized Abdominal Wall Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and postoperative month 12. 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From surgery through postoperative day 30. 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start12 Jan 2024
- Primary completion1 Sep 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diastasis Recti AbdominisStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jose D Salazar, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805915
- Sponsor's protocol ID
- 011
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no contemplated in the patient informed consent
Publications
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.
PubMed 40801412Swanson 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.
PubMed 39774064Restifo 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.
PubMed 38967610Marchica 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.
PubMed 36609741Staalesen 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.
PubMed 26595030Wilting 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.
PubMed 37903329
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
- ClinicalTrials.gov ID
- NCT07805915
- Acronym / sponsor ID
- 011
- Conditions
- Diastasis Recti Abdominis, Abdominal Wall Laxity
- Keywords
- Abdominoplasty, Rectus Abdominis Plication, Diastasis Recti, Ultrasound, Abdominal Wall Function, Recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigator-Developed Rectus Plication | Experimental | Procedure: Investigator-Developed Rectus Abdominis Plication, Diagnostic Test: Standardized Abdominal Wall UltrasoundParticipants undergo abdominoplasty with the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up. |
| abdominoplasty with linear rectus plication | Active comparator | Diagnostic Test: Standardized Abdominal Wall UltrasoundParticipants undergo abdominoplasty with linear rectus plication the standardized control; investigator-perform plication and complete one-year anatomical, functional, and safety follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigator-Developed Rectus Abdominis PlicationA 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. | Procedure or surgery | Investigator-Developed Rectus Plication |
| Standardized Abdominal Wall UltrasoundInter-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. | Diagnostic test | Investigator-Developed Rectus Plication, abdominoplasty with linear rectus plication |
Primary outcome
Change in Mean waist perimeter
Time frame: Baseline and postoperative month 12. 12 months
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.
4 secondary outcomes
Incidence of Plication-Related Major Complications
Time frame: From surgery through postoperative month 12.
Change in Abdominal Wall Physical Function
Time frame: Baseline, postoperative month 3, and postoperative month 12.
Change in BODY-Q Abdomen Satisfaction Score
Time frame: Baseline, postoperative month 6, and postoperative month 12.
Incidence of Standard Abdominoplasty Complications
Time frame: From surgery through postoperative day 30. 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 40801412Amro 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.
- Background: PubMed 39774064Swanson 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.
- Background: PubMed 38967610Restifo 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.
- Background: PubMed 36609741Marchica 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.
- Background: PubMed 26595030Staalesen 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.
- Background: PubMed 37903329Wilting 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.
- Individual participant dataSharing planned: No. no contemplated in the patient informed consent
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jose D Salazar principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigator-Developed Rectus Abdominis Plication and Standardized Abdominal Wall Ultrasound in people with Diastasis Recti Abdominis and Abdominal Wall Laxity, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jose D Salazar, MD, Plastic surgeon (+57 311 6058486, heimdal007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean waist perimeter (time frame: Baseline and postoperative month 12. 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805915, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.