Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Satisfaction of body results
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Satisfaction of body results
时间窗: 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
Body-QoL total score (0-100) from baseline to 6 months.
Change in waist circumference (cm)
时间窗: 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), reduction of the waist circumference
次要结局
- Safety Endpoint(1 week before surgery and 6 months after surgery)
研究者
Brian Ramirez, MD, MSc
MD, Aerospace medicine, MSc, PhD(c)
Research Inc