Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
1. september 2026 opdateret af: Research Inc
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jose D Salazar, MD, Plastic surgeon
- Telefonnummer: +57 311 6058486
- E-mail: heimdal007@gmail.com
Studiesteder
-
-
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Medellín, Colombia
- Rekruttering
- IQ interquirofanos
-
Kontakt:
- Jose D Salazar, MD, Plastic surgeon
- Telefonnummer: +57 311 6058486
- E-mail: heimdal007@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Investigator-Developed Rectus Plication
Participants undergo abdominoplasty with the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.
|
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.
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Aktiv komparator: abdominoplasty without plication
Participants undergo abdominoplasty without the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Mean waist perimeter
Tidsramme: Baseline and postoperative month 12. 12 months
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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.
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Baseline and postoperative month 12. 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Plication-Related Major Complications
Tidsramme: From surgery through postoperative month 12.
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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.
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From surgery through postoperative month 12.
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Change in Abdominal Wall Physical Function
Tidsramme: Baseline, postoperative month 3, and postoperative month 12.
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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.
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Baseline, postoperative month 3, and postoperative month 12.
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Change in BODY-Q Abdomen Satisfaction Score
Tidsramme: Baseline, postoperative month 6, and postoperative month 12.
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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.
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Baseline, postoperative month 6, and postoperative month 12.
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Incidence of Standard Abdominoplasty Complications
Tidsramme: From surgery through postoperative day 30. 30 days
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Proportion with seroma requiring aspiration, hematoma, surgical-site infection, wound dehiscence, skin necrosis, venous thromboembolism, or unplanned reoperation.
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From surgery through postoperative day 30. 30 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: jose D Salazar
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. januar 2024
Primær færdiggørelse (Faktiske)
1. september 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
1. september 2026
Først indsendt, der opfyldte QC-kriterier
1. september 2026
Først opslået (Faktiske)
8. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 011 (Nahrain Medical Research Collective (NMRC))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
no contemplated in the patient informed consent
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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