Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this observational study is to learn about the long-term effects of RIBOSS intervention and demonstrate non-inferiority of postoperative respiratory function (FEV1, FVC, FEV1/FVC) at 6 months in the RIBOSS group compared with controls, using a non-inferiority margin of ≤0.10 L for FEV1 and FVC, and ≤0.05 for the ratio.
Secondary Objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| Control Arm | Standard liposculpture (VASER and/or MicroAire-assisted) without rib osteosynthesis. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of body results | Body-QoL total score (0-100) from baseline to 6 months. | 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 |
| Change in waist circumference (cm) | Change in waist circumference (cm), reduction of the waist circumference | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | spirometry values (FEV1, FVC, FEV1/FVC) from before surgery to 6 months after surgery | 1 week before surgery and 6 months after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hugo Aguilar, MD, plastic surgery | HAV Academy | Principal Investigator |
| Brian Ramirez, MD, Aerospace medicine, MSc, P | Research Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica INO | Bogotá | Bogota D.C. | 110121 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39838130 | Background | 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. | |
| 38204869 |
Not provided
Not provided
It only be able if it is required by someone
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: old one | Feb 20, 2026 |
Not provided
Not provided
Not provided
Not provided
| Background |
| 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. |
| 36891563 | Background | 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. |
| 38710099 | Background | 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. |
| 40874070 | Background | 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. |
| 34262840 | Background | 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. |
| Feb 21, 2026 |
| Prot_SAP_ICF_000.pdf |
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: new one with committe approval | Jul 9, 2026 | Jul 10, 2026 | Prot_SAP_ICF_001.pdf |