Clinical Research Directory

Prevalence of Pelvic Venous Congestion Syndrome in Female Patients With Lower Extremity Varicose Veins and Its Impact on Postoperative Quality of Life Improvement Following Radiofrequency Ablation: A Single-Center Prospective Cohort Study（PCSRFStudy）

Sponsor: Chengdu University of Traditional Chinese Medicine

Summary

Research Summary: Impact of Pelvic Congestion Syndrome on Lower Limb Varicose Vein Treatment This prospective cohort study investigates the prevalence of Pelvic Congestion Syndrome (PCS) among women undergoing lower limb varicose vein ablation and its impact on post-operative quality of life. Background PCS, a significant cause of chronic pelvic pain, results from pelvic venous insufficiency and hypertension. This pressure can transmit to the leg veins via pelvic-lower limb collaterals, potentially causing or exacerbating varicose veins. Despite this pathophysiological link, systematic PCS screening is absent in pre-operative assessments for lower limb venous surgery, leading to underdiagnosis and untreated root causes. Objectives Primary: Determine the prevalence of PCS in symptomatic women scheduled for radiofrequency ablation, using the latest international diagnostic criteria requiring both specific symptoms and imaging evidence while excluding other pathologies. Secondary: Compare post-operative quality-of-life improvement between PCS-positive and PCS-negative patients and identify predictors of poorer outcomes. Methodology This single-center prospective observational study enrolls women aged 20-60 with CEAP C2-C6 varicose veins planned for ablation. All patients undergo mandatory gynecological evaluation to rule out other pelvic diseases and a standardized pelvic MRI. PCS diagnosis follows strict composite criteria: Symptom Criteria: Presence of ≥2 typical symptoms (e.g., chronic pelvic pain \>6 months) with a clear "venous pattern" (worsening with prolonged standing/sitting, relief with recumbency). Imaging Criteria: MRI confirmation of significant pelvic venous dilation and tortuosity (e.g., ovarian/internal iliac veins). Patients meeting both criteria form the PCS-positive cohort; others form the control group. Crucially, diagnosed PCS is not treated during the study phase. All receive only standard lower limb radiofrequency ablation. Follow-ups occur at 1, 6, and 12 months post-operation, with the primary outcome being the change in the vein-specific quality of life score (CIVIQ-20). Innovation and Value This study innovates by systematically applying the latest multidisciplinary diagnostic consensus for PCS within a large venous surgery cohort and prioritizing patient-reported outcomes. Its expected value is threefold: To provide high-level evidence on the true prevalence of PCS in this population. To inform clinical practice, potentially establishing a pre-operative PCS screening pathway to enable comprehensive treatment and avoid ineffective isolated leg vein procedures. To identify PCS-positive patients as a high-risk subgroup, laying the essential groundwork for future randomized controlled trials comparing combined pelvic-lower limb interventions versus isolated leg vein treatment. Conclusion By elucidating the association between PCS and lower limb venous disease outcomes, this study aims to shift the treatment paradigm from isolated management of leg veins to a holistic approach addressing the entire venous system in women.

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