Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Rate of re-hospitalization within 30 days after surgery
研究概览
简要总结
Functional popliteal artery entrapment syndrome (FPAES) is a rare and under-diagnosed clinical entity characterized by dynamic compression of the popliteal artery during exercise in the absence of a visible anatomic abnormality at rest. It preferentially affects young, otherwise healthy athletes (3,4). Although surgical release is the reference treatment, the literature relies mainly on small case series, surgical management is poorly standardized, and data on early post-operative morbidity (complications, re-hospitalization) are often lacking. This prospective, single-center, non-interventional study aims to describe the safety of the surgical management of FPAES as performed in routine care in the vascular surgery department of Ambroise Paré Hospital (AP-HP), a national reference center for this condition. The primary endpoint is the rate of re-hospitalization within 30 days of surgery. Secondary objectives address risk factors for re-hospitalization, minor adverse events, and the clinical and functional outcome of patients, including return to sport, assessed using the Lower Extremity Functional Scale (LEFS).
详细描述
This is a prospective, single-center, non-interventional study conducted in the vascular surgery department of Ambroise Paré Hospital (AP-HP). Adult patients undergoing surgical management for FPAES are enrolled prospectively over a 24-month inclusion period (target: 138 patients) and followed for 36 months. Eligible patients are identified at the pre-operative consultation. Demographic, surgical, and clinical data are collected from the medical record at follow-up visits (M1, M3, M6, M12, M24, M36). The primary outcome is the rate of re-hospitalization within 30 days of surgery; post-operative adverse events (hematoma, surgical-site infection, deep vein thrombosis, and re-hospitalization) are recorded through day 30. Patient-reported lower-extremity function is assessed with the Lower Extremity Functional Scale (LEFS; validated French version), self-completed on paper the day before surgery and again at 6 months. Statistical analyses will be performed in R: the 30-day re-hospitalization proportion will be estimated with its 95% confidence interval (Wilson method), risk factors will be examined by univariate then multivariate logistic regression, and the change in LEFS impairment categories between baseline and 6 months will be compared using a test for paired data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Patients with documented functional popliteal artery entrapment syndrome (FPAES).
- •Patients undergoing surgical management of FPAES in the vascular surgery department of Ambroise Paré Hospital (AP-HP).
- •Having received the information note and not having expressed opposition to participation in the study.
排除标准
- •Anatomical popliteal artery entrapment syndrome.
- •Patient refusal.
- •Inability to understand the proposed research and/or to express non-opposition.
结局指标
主要结局
Rate of re-hospitalization within 30 days after surgery
时间窗: at 30 days
The primary endpoint is the proportion of patients re-hospitalized for any cause within the 30 days following the surgical procedure.
次要结局
- Demographic data, surgery-related data, and associated medical and surgical history associated with re-hospitalization within 30 days post-surgery.(at 30 days)
- Change in patient-reported lower-extremity function and impairment category, assessed with the Lower Extremity Functional Scale(at baseline and 6 months)
- Clinical evolution(at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36)
- Return to sporting activities(at Month 1, Month 3, Mounth 6, Mmonth 12, Month 24 and Month36)