Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins (PESIV)
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- STATUS
- Recruiting
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- End date
- Dec 30, 2023
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- participants needed
- 84
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- sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.
Description
Background: Incompetent perforating vein (IPV) is one of the important causes of persistent venous ulcers of lower extremities and recurrence after operation of varices which is a hot button issue worth discussing in clinical practice. Minimally invasive surgery has become the trend of IPVs' treatment. Currently, sclerotherapy can be performed to treat incompetent perforating veins, which showed a 90% occlusion rate after three or fewer sessions, the recurrence was present nearly 1/3 of cases. While electrocoagulation has a reliable effect on the closure of incompetent perforating veins and simplify treatment. No comparative studies of different PAPS modalities are currently available. Therefore, this study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforating veins. Methods:This study is a multicenter, randomized controlled trial. We will recruit 84 patients with IPVs from five hospitals. Moreover, these patients will be randomized to either the experimental group (electrocoagulation) or the control group (sclerotherapy). The primary outcome is incompetent perforating veins occlusion rate in the 12th month. Secondary outcomes are quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score), skin ulcer recurrence rate, deep venous Thrombosis, hemorrhage, all-cause mortality, and other vascular events and serious complications.Discussion:This study will provide reliable, evidence-based clinical evidence for the efficacy of electrocoagulation therapy for incompetent perforating veins.
Details
| Condition | Incompetent Perforating Veins |
|---|---|
| Treatment | treatment: puncture of coagulation, treatment: sclerosing agent injected |
| Clinical Study Identifier | NCT04686097 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Last Modified on | 7 October 2022 |
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