Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
1. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jose D Salazar, MD, Plastic surgeon
- Telefonnummer: +57 311 6058486
- E-post: heimdal007@gmail.com
Studiesteder
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Medellín, Colombia
- Rekruttering
- IQ interquirofanos
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Ta kontakt med:
- Jose D Salazar, MD, Plastic surgeon
- Telefonnummer: +57 311 6058486
- E-post: heimdal007@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Investigator-Developed Rectus Plication
Participants undergo abdominoplasty with the standardized investigator-developed plication and complete one-year anatomical, functional, and safety follow-up.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: jose D Salazar
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. januar 2024
Primær fullføring (Faktiske)
1. september 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
1. september 2026
Først innsendt som oppfylte QC-kriteriene
1. september 2026
Først lagt ut (Faktiske)
8. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 011 (Nahrain Medical Research Collective (NMRC))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
no contemplated in the patient informed consent
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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