Prospective Assessment of Quality of Life Following Radiofrequency Ablation for Chronic Venous Insufficiency in Kinshasa

Prospective Assessment of Quality of Life and Clinical Outcomes Following Endovenous Radiofrequency Ablation for Chronic Venous Insufficiency: A Single-Center Cohort Study in Kinshasa, DR Congo

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202603746307779

Enrollment

Registered

2026-03-24

Start date

2026-03-09

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory System Skin and Connective Tissue Diseases Surgery

Interventions

Endovenous Radiofrequency Ablation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must meet all of the following: - Age = 18 years - Clinical diagnosis of chronic venous insufficiency (CEAP class C3..C6) with documented reflux in the GSV, SSV, or AAGSV. - Currently receiving or eligible for standard-of-care adjuvant therapy (e.g., compression therapy or wound care). - Able to finance the intervention - Able to understand and complete quality-of-life questionnaire in French - Able to provide written informed consent

Exclusion criteria

Exclusion criteria: Participants meeting any of the following are excluded: • Acute deep vein thrombosis or thrombophlebitis within 3 months prior to RFA • Non-necrotizing dermohypodermitis (cellulitis/erysipelas) within 1 month prior to RFA • Known arterial insufficiency (ABI < 0.9). • Pregnancy or breastfeeding • Participation in another interventional trial • Severe comorbidities that limit expected 12-month follow-up (e.g. terminal illness) • Known allergy or contraindication to procedural materials (e.g. anesthetics, catheter components)

Design outcomes

Primary

Measure	Time frame
Change in VEINES-QOL score from baseline (pre-intervention) () to 12 months (+/- 4 weeks) post-intervention. () Baseline: This is defined as the morning of the intervention (Radiofrequency Ablation). Baseline measurement for VEINES-QOL will be collected immediately prior to the procedure. In this study, we define 3 time points i.e. T0 as the baseline, T1 as 3 months post-intervention, and T2 as 12 months post-intervention.	—

Measure

Time frame

Change in VEINES-QOL score from baseline (pre-intervention) (*) to 12 months (+/- 4 weeks) post-intervention. (*) Baseline: This is defined as the morning of the intervention (Radiofrequency Ablation). Baseline measurement for VEINES-QOL will be collected immediately prior to the procedure. In this study, we define 3 time points i.e. T0 as the baseline, T1 as 3 months post-intervention, and T2 as 12 months post-intervention.

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Secondary

Measure	Time frame
Change in VEINES-QOL score from baseline (pre-intervention) to 3 months post-intervention (+/- 2 weeks).;Change in VEINES-Sym scores from baseline (pre-intervention) () to 3 months (+/- 2 weeks) and 12 months (+/- 4 weeks) post-intervention. () Baseline: This is defined as the morning of the intervention (Radiofrequency Ablation). Baseline measurement for VEINES-Sym will be collected immediately prior to the procedure. ;Change in VCSS (Venous Clinical Severity Score) score from baseline (pre-intervention) () to 3 months (+/- 2 weeks) and 12 months (+/- 4 weeks) post-intervention () Baseline: This is defined as the morning of the intervention (Radiofrequency Ablation). Baseline measurement for VCSS will be collected immediately prior to the procedure.	—

Measure

Time frame

Change in VEINES-QOL score from baseline (pre-intervention) to 3 months post-intervention (+/- 2 weeks).;Change in VEINES-Sym scores from baseline (pre-intervention) (*) to 3 months (+/- 2 weeks) and 12 months (+/- 4 weeks) post-intervention. (*) Baseline: This is defined as the morning of the intervention (Radiofrequency Ablation). Baseline measurement for VEINES-Sym will be collected immediately prior to the procedure. ;Change in VCSS (Venous Clinical Severity Score) score from baseline (pre-intervention) (*) to 3 months (+/- 2 weeks) and 12 months (+/- 4 weeks) post-intervention (*) Baseline: This is defined as the morning of the intervention (Radiofrequency Ablation). Baseline measurement for VCSS will be collected immediately prior to the procedure.

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Countries

Democratic Republic of the Congo

Contacts

Public ContactBenjamin TATETE OKITASOMBO

Vascular Surgeon

drtatete@gmail.com+32485873527

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Jun 29, 2026