- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07705295
RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing ((RIBOSS))
Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Secondary Objectives:
- To quantify hip circumference, change and waist-hip ratio improvement.
- To compare intraoperative and postoperative pain levels (VAS) up to 1 month.
- To assess radiological consolidation and plate angulation at 3 and 6 months.
- To record early and late complications (Clavien-Dindo classification) up to 12 months.
- To measure time to return to physical activity and overall satisfaction.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110121
- Clinica INO
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
The study population will consist of adult male and female patients aged 18 to 45 years seeking elective waist narrowing through high-definition liposculpture at participating center in Bogotá, Colombia.
Eligible participants must have a body mass index (BMI) ≤30 kg/m² and demonstrate prominent projection of floating ribs (ribs XI-XII) ≥7 cm on preoperative computed tomography (CT), making them anatomically suitable candidates for structural waist modification. All participants must present with normal baseline spirometry values (FEV1, FVC, and FEV1/FVC within predicted limits) to ensure adequate pulmonary reserve prior to intervention.
Participants must be medically fit for elective surgery under general anesthesia and capable of providing written informed consent and completing patient-reported outcome measures, including the Body-QoL questionnaire.
Exclusion criteria include prior thoracic surgery or trauma, rib agenesis, osteoporosis or metabolic bone disease, c
Beskrivelse
Inclusion Criteria:
- Candidates for elective waist narrowing through high-definition liposculpture.
- Rib XI-XII projection ≥7 cm (CT-based).
- Baseline spirometry within predicted limits.
- Ability to provide informed consent and complete Body-QoL questionnaire.
Exclusion Criteria:
- Prior thoracic surgery, trauma, or rib agenesis.
- Osteoporosis or bone metabolic disease.
- Chronic pulmonary or systemic disease.
- Coagulopathy or psychiatric disorder limiting adherence.
- Pregnancy or lactation.
- Allergy to titanium implants.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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RIBOSS Arm (Intervention)
Rib Osteotomy with Osteosynthesis Stabilization (RIBOSS) plus liposculpture Procedure: 2-3 cm incision 7 cm lateral to the midline over ribs XI-XII. Periosteal elevation and monocortical osteotomy using piezotome (Cube, Finapolline, France). Controlled greenstick fracture, preserving pleura and neurovascular bundle. Internal fixation with pre-bent 1.5-mm titanium plates (MatrixRIB, Synthes) using 5-hole segments and 6-8 mm screws (two medial, two distal). Mean angulation: 45° (ribs X-XI), 55° (rib XII). Layered closure with absorbable sutures. No corset required postoperatively. |
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Control Arm
Standard liposculpture (VASER and/or MicroAire-assisted) without rib osteosynthesis.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Satisfaction of body results
Tidsramme: 1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
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Body-QoL total score (0-100) from baseline to 6 months.
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1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
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Change in waist circumference (cm)
Tidsramme: 1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
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Change in waist circumference (cm), reduction of the waist circumference
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1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Safety Endpoint
Tidsramme: 1 week before surgery and 6 months after surgery
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spirometry values (FEV1, FVC, FEV1/FVC) from before surgery to 6 months after surgery
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1 week before surgery and 6 months after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Hugo Aguilar, MD, plastic surgery, HAV Academy
- Studieleder: Brian Ramirez, MD, Aerospace medicine, MSc, P, Research Inc
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Ferreira LM, Bonin GS, Bernardes ABS, Dos Anjos GF, Tariki JY, Boechat C, Cunha MS, Cosac OM, Ferreira PEN, Aloe RC, Ikuta Y, Correa WEM, Felix GAA, Isoldi FC. Is There Scientific Evidence on the Practice of Rib Resection or Remodeling for Body Contouring Purposes?-A Systematic Review. Aesthetic Plast Surg. 2025 Apr;49(7):2007-2014. doi: 10.1007/s00266-025-04685-3. Epub 2025 Jan 21.
- 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.
- Chiu YH, Chiu YJ, Lee CC, Wang TH, Lee JL. Ant Waist Surgery: Aesthetic Removal of Floating Ribs to Decrease the Waist-hip Ratio. Plast Reconstr Surg Glob Open. 2023 Mar 6;11(3):e4852. doi: 10.1097/GOX.0000000000004852. eCollection 2023 Mar.
- 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.
- Hoyos AE, Perez Pachon ME, Duarte P, Aguilar Villa H, Proto R, Borras-Osorio M, Castiblanco MP, Leon-Machicado M. Waistline Aesthetic Slimming by Puncture and Parallel Approach for Rib Remodeling Procedures. Aesthet Surg J Open Forum. 2025 May 27;7:ojaf044. doi: 10.1093/asjof/ojaf044. eCollection 2025.
- Kudzaev KU, Kraiushkin IA. Waist Narrowing without Removal of Ribs. Plast Reconstr Surg Glob Open. 2021 Jul 12;9(7):e3680. doi: 10.1097/GOX.0000000000003680. eCollection 2021 Jul.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 002 (University of CT Health Center)
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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