Prospective Evaluation of Body Image, Physical, Psychological, Sexual, and Social Outcomes After Posterior Aesthetic Rib Remodeling
1. september 2026 oppdatert av: Research Inc
This prospective observational cohort will evaluate patient-reported and anthropometric outcomes after posterior aesthetic rib remodeling.
Selected BODY-Q scales will measure body image, physical, psychological, sexual, and social function before surgery and through 12 months.
Standardized waist and hip measurements will be collected at the same visits.
The primary outcome is change in BODY-Q Body Image score at one year, and analyses will assess whether patient-reported improvement is associated with sustained waist reduction.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Adults who independently elect posterior rib remodeling will be enrolled before surgery.
The study will administer a prespecified subset of licensed BODY-Q scales and will obtain standardized anthropometric and photographic measurements at baseline and at 1, 3, 6, and 12 months.
Each BODY-Q scale will be scored independently.
Mixed-effects models will estimate change in body image and other functional domains, and regression analyses will assess whether changes correspond to objective waist reduction.
Complications and major weight change will be incorporated into the interpretation of outcomes.
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: hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 301 6918526
- E-post: havplasticacademy@gmail.com
Studiesteder
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Bogotá, Colombia
- Rekruttering
- Clinica INO
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Ta kontakt med:
- hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 3016918526
- E-post: havplasticacademy@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
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults who independently elect posterior aesthetic rib remodeling and agree to longitudinal anthropometric and patient-reported outcome assessment.
Beskrivelse
Inclusion Criteria:
- Age 18 to 65 years.
- Scheduled for posterior aesthetic rib remodeling after an independent clinical decision.
- Ability to complete validated Spanish-language BODY-Q scales and follow-up visits.
- Stable body weight for at least 3 months before surgery.
- Written informed consent for prospective data collection.
Exclusion Criteria:
- Prior posterior rib remodeling or rib resection.
- Planned pregnancy during the 12-month follow-up.
- Major weight-loss intervention planned during follow-up.
- Psychiatric or cognitive condition preventing reliable completion of patient-reported measures.
- Inability to complete baseline BODY-Q or standardized waist measurement.
- Participation in another intervention expected to independently alter body image outcomes during follow-up.
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 |
|---|---|
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Posterior Rib Remodeling Cohort
Participants undergo the clinically selected posterior rib remodeling procedure and complete prospective BODY-Q and anthropometric assessments.
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Posterior rib remodeling is performed according to the treating surgeon's standardized RIBOSS technique and clinical indications.
The research protocol does not assign surgery; it observes outcomes after the independent treatment decision.
Linked arm/group(s): Posterior Rib Remodeling Cohort.
Selected licensed BODY-Q scales will be administered using the authorized Spanish translation and Rasch transformation.
Proposed scales are Body Image, Physical Function, Psychological Function, Sexual Function, Social Function, and Body or Abdomen appearance satisfaction.
Linked arm/group(s): Posterior Rib Remodeling Cohort.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in BODY-Q Body Image Score
Tidsramme: Baseline and postoperative month 12. 1 year
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Rasch-transformed 0-to-100 BODY-Q Body Image score; higher scores indicate a more positive body image.
Change is the postoperative month-12 score minus baseline.
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Baseline and postoperative month 12. 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in BODY-Q Sexual Function Score
Tidsramme: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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Rasch-transformed 0-to-100 BODY-Q Sexual Function score; higher scores indicate better self-reported sexual function and comfort with body appearance.
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Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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Change in BODY-Q Physical, Psychological, and Social Function Scores
Tidsramme: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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Each selected BODY-Q scale is independently transformed to 0 to 100, with higher scores indicating better function.
Scores will not be combined into an unvalidated total.
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Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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Change in Waist Circumference
Tidsramme: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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Waist circumference in centimeters will be measured at a fixed anatomical landmark at end-expiration, using three repeated measurements averaged at each visit.
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Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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Association Between Waist Reduction and BODY-Q Improvement
Tidsramme: Baseline and postoperative month 12. 1 year
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Correlation and adjusted regression between change in waist circumference and change in each prespecified BODY-Q domain.
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Baseline and postoperative month 12. 1 year
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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: Hugo Aguilar, 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
- Onate Valdivieso C, Onate Valdivieso D, Hoyos AE, Perez Pachon ME, Aguilar Villa H, Michels PJA, Viera A, Benavides JE, Villabona SJ, Ramirez B. Ultrasonic- and Ultrasound-assisted Improvement of Silhouette of the Torso: Bone Structure High-definition Remodeling (Part I). Plast Reconstr Surg Glob Open. 2024 Jan 10;12(1):e5513. doi: 10.1097/GOX.0000000000005513. eCollection 2024 Jan.
- Aguilar Villa H, Villabona-Florez SJ, Hoyos AE, Perez Pachon ME, Serrano-Reyes HM, Diaz Sandoval CJ. Aesthetic Rib Cage Remodeling with Osteosynthesis: Body Structural High-Definition Reshaping (Rib Osteotomy with Osteosynthesis Stabilization). Plast Reconstr Surg. 2025 Feb 1;155(2):279-288. doi: 10.1097/PRS.0000000000011512. Epub 2024 May 6.
- Manzaneda Cipriani RM, Duran Vega H, Cala Uribe L, Viaro M, Adrianzen GA, Botelho DL. Waist Remodeling without Incision, with Ultrasound-guided Monocortical Fracture. Plast Reconstr Surg Glob Open. 2023 Dec 19;11(12):e5499. doi: 10.1097/GOX.0000000000005499. eCollection 2023 Dec.
- Aguilar HA, Hoyos AE, Ramirez B, Kazbek K, Viacheslav N, Villabona SJ, Serrano HM, Perez Pachon ME, Valdivieso DO, Valdivieso CO, Kazbek G, Proto R, Verdugo JP, Varela A. Global Survey on Rib Remodeling Techniques: Assessing Complications and Safety in Waistline Contouring. Plast Reconstr Surg Glob Open. 2026 Apr 13;14(4):e7609. doi: 10.1097/GOX.0000000000007609. eCollection 2026 Apr.
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)
1. februar 2024
Primær fullføring (Faktiske)
1. mai 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
Andre studie-ID-numre
- 014 (Nahrain Medical Research Collective (NMRC))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
NOT CONTEMPLED 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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