Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease
7. september 2026 oppdatert av: Research Inc
This prospective paired diagnostic-impact study will compare conventional qualitative MRI reporting with a new structured anatomic classification in adults undergoing surgery for gluteal permanent synthetic filler disease.
The structured report will document material effects across superficial, deep, muscular, regional, lymphatic, and interstitial compartments.
Standardized intraoperative mapping will serve as the reference standard.
The main outcome is the difference in sensitivity for surgically confirmed compartment involvement
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
Eligible participants will undergo a standardized pelvic and gluteal MRI before planned filler-removal surgery.
The same examination will be interpreted using two prespecified formats: a conventional qualitative report and a structured report that grades involvement of the fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal, ischial, trochanteric, and pelvic-ring regions, as well as lymphatic and interstitial pathways.
The operating surgeon will record a preliminary plan and utility rating after each report.
During surgery, actual compartment involvement will be documented using a standardized map and, when available, specimen and histopathologic findings.
Paired diagnostic performance, inter-reader agreement, change in surgical planning, and associations with operative complexity will be analyzed.
Studietype
Observasjonsmessig
Registrering (Antatt)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Edison Osorio, MD, Plastic surgeon
- Telefonnummer: +573226140611
- E-post: info@edisonosorio.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
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.
Beskrivelse
Inclusion Criteria:
- Age 18 years or older.
- History of gluteal injection with a permanent or unknown nonresorbable filler.
- Preoperative pelvic/gluteal MRI performed using the study acquisition protocol.
- Planned surgical removal, biopsy, or operative exploration within 90 days after MRI.
- Written informed consent for paired image interpretation and use of operative findings.
Exclusion Criteria:
- MRI contraindication or nondiagnostic imaging caused by motion or incomplete anatomic coverage.
- Prior extensive gluteal filler removal that prevents mapping of the predefined compartments.
- No operative procedure within 90 days after MRI and therefore no reference-standard assessment.
- Acute life-threatening infection or emergency surgery that prevents completion of the preoperative reporting sequence.
- Inability to provide consent.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Paired MRI Interpretation Cohort
Each participant has the same MRI interpreted with the conventional qualitative format and with the structured anatomic classification before the index operation.
|
The report records the presence or absence of injected foreign material in the gluteal region and any routinely reported findings.
A preliminary surgical plan is recorded after review of this report.
Linked arm/group(s): Paired MRI Interpretation Cohort.
The report records material distribution and severity in predefined compartments: fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal region, ischial region, trochanteric region, pelvic ring, lymphatic pathways, and interstitial involvement.
The final classification manual and grade definitions will be locked before enrollment.
Linked arm/group(s): Paired MRI Interpretation Cohort.
During the index operation, the surgeon documents actual involvement of each predefined compartment before reviewing the imaging accuracy analysis.
Operative photographs, specimen mapping, and histopathology may support the reference standard.
Linked arm/group(s): Paired MRI Interpretation Cohort.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity for Surgically Confirmed Anatomic Compartment Involvement
Tidsramme: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days
|
For each reporting method, sensitivity is the number of predefined compartments identified as involved on MRI divided by the number confirmed as involved during standardized intraoperative mapping.
The structured and conventional results will be compared within the same participant.
|
Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Specificity for Surgically Uninvolved Anatomic Compartments
Tidsramme: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 dys
|
For each method, specificity is the number of compartments correctly identified as uninvolved on MRI divided by the number documented as uninvolved at surgery.
|
Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 dys
|
|
Change in Preoperative Surgical Plan After Structured MRI Review
Tidsramme: Immediately after the conventional report and immediately after the structured report, both before surgery. 1 day
|
Proportion of participants for whom the recorded operative plan changes after the structured report, including planned incision, extent of excision, anticipated deep-plane dissection, lymphatic evaluation, or reconstruction strategy.
|
Immediately after the conventional report and immediately after the structured report, both before surgery. 1 day
|
|
Surgeon-Rated MRI Report Utility
Tidsramme: Immediately after review of each preoperative MRI report. 1 day
|
The operating surgeon rates completeness, anatomic clarity, confidence, and usefulness for planning on prespecified 0-to-10 scales after each report.
Higher scores indicate greater perceived utility.
|
Immediately after review of each preoperative MRI report. 1 day
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Edison Osorio, MD, plastic surgery
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
- Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.
- Yahyavi-Firouz-Abadi N, Menias CO, Bhalla S, Siegel C, Gayer G, Katz DS. Imaging of cosmetic plastic procedures and implants in the body and their potential complications. AJR Am J Roentgenol. 2015 Apr;204(4):707-15. doi: 10.2214/AJR.14.13516.
- Niasme E, Delattre BMA, Lenoir V, Modarressi A, Poletti PA, Becker M, Boudabbous S. Quantitative magnetic resonance imaging: differentiating soft tissue implants and fillers used in cosmetic and reconstructive surgery. Skeletal Radiol. 2021 Jan;50(1):231-237. doi: 10.1007/s00256-020-03564-z. Epub 2020 Aug 5.
- Soliman SB. Liquid silicone filler migration following illicit gluteal augmentation. Radiol Case Rep. 2023 Jan 5;18(3):984-990. doi: 10.1016/j.radcr.2022.12.049. eCollection 2023 Mar.
- Leyva A, Tran T, Cibulas AT, Warden D, Danger FJ, Scherer K, Wasyliw C. Filler Migration and Granuloma Formation After Gluteal Augmentation with Free-silicone Injections. Cureus. 2018 Sep 13;10(9):e3294. doi: 10.7759/cureus.3294.
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 (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
31. desember 2026
Datoer for studieregistrering
Først innsendt
1. september 2026
Først innsendt som oppfylte QC-kriteriene
7. 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
7. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 007
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
no, due the privacity and informed consents signed by the patients
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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