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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Bogota D.C.
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Bogotá, Bogota D.C., 콜롬비아, 110121
- Clinica INO
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Satisfaction of body results
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Safety Endpoint
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Hugo Aguilar, MD, plastic surgery, HAV Academy
- 연구 책임자: Brian Ramirez, MD, Aerospace medicine, MSc, P, Research Inc
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 002 (University of CT Health Center)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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