Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease
7 september 2026 bijgewerkt door: 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
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Geschat)
200
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Edison Osorio, MD, Plastic surgeon
- Telefoonnummer: +573226140611
- E-mail: info@edisonosorio.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Adults with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sensitivity for Surgically Confirmed Anatomic Compartment Involvement
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Specificity for Surgically Uninvolved Anatomic Compartments
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Edison Osorio, MD, plastic surgery
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 oktober 2026
Primaire voltooiing (Geschat)
1 december 2026
Studie voltooiing (Geschat)
31 december 2026
Studieregistratiedata
Eerst ingediend
1 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 september 2026
Eerst geplaatst (Werkelijk)
8 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 september 2026
Laatste update ingediend die voldeed aan QC-criteria
7 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 007
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
no, due the privacity and informed consents signed by the patients
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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