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临床试验/NCT02676908
NCT02676908Unknown不适用

A Randomised Controlled Trial Comparing Duration of Compression Hosiery After Endovenous Ablation of Varicose Veins

St. James's Hospital, Ireland2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
110
试验地点
2
主要终点
Pain Scores on the Visual Analog Scale

研究概览

简要总结

Compression stockings are traditionally worn for a period of time after varicose vein surgery to reduce pain and bruising. The investigators provide an ambulatory endovenous ablation service. Patients come to the Veins Unit, receive oral sedation, have their veins treated with either laser or radiofrequency ablation plus phlebectomies* under local anaesthetic, recover for an hour and then go home. *Phlebectomy describes the technique of pulling out small varicose veins through small incisions in the overlying skin. The standard practice of the Veins Unit is to advise patients to wear class two compression stockings for four weeks post-operatively. Many patients would prefer a shorter period of time in stockings.

The Nice Guidelines for Varicose Veins has posed the question: 'How long should stockings be worn for after endovenous ablation?'

Three trials have addressed this issue:

Bakker looked at patients who wore stockings for either two or seven days after laser ablation only; the group who wore stockings for seven days fared better.

Elderman looked at patients who either wore no stockings or stockings for two weeks after laser ablation only; the group who wore stockings for two weeks had less pain.

Krasznai looked at patients who wore stockings for either 4 hours or 72 hours after radiofrequency ablation only; there was no significant difference in post-op pain among groups.

None of these trials included patients who had phlebectomies at the same time. This study aims to answer the question 'How long is it necessary to wear compression stockings for after endovenous ablation (either laser or radiofrequency) plus concomitant phlebectomies?' The investigators plan to divide 110 patients into two groups- either 'stockings for 2 weeks' (trial group) or 'stockings for 4 weeks' (usual treatment group).

Pre-operatively, all patients will fill out a pain score and two short quality of life questionnaires, one specific to varicose veins. Post-operatively at home, all patients will be asked to keep a diary of pain and analgesia use. They will also document bruising at seven days on charts and on a visual scale. At their four week clinic review, all patients will be asked to fill out a pain and bruising score, a bruising chart and the two short quality of life questionnaires again.

The group with the best pain, bruising and quality of life scores post-operatively will help guide duration of compression therapy for future patients.

详细描述

The Nice Guidelines for Varicose Veins, published by the NHS in 2013, questioned the clinical benefit of stockings after endovenous ablation, and if there is benefit, how long the stockings should be worn for.

Three randomised controlled trials have addressed these issues:

Bakker and colleagues randomised 69 patients into two groups- stockings were worn for either two or seven days after laser ablation. The group who wore stockings for seven days had better pain and quality of life scores.

Elderman and colleagues randomised 111 patients who had laser ablation into two groups- a group who wore no stockings, or a group who wore stockings for two weeks. The group who wore stockings for two weeks had less pain and required less analgesia.

Krasznai and colleagues randomised 101 patients into two groups- stockings were worn for either 4 hours or 72 hours after radiofrequency ablation only; there was no significant difference in post-op pain among groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary or recurrent varicose veins
  • Diagnosis on duplex of truncal (GSV and/or SSV and/or AATV) insufficiency
  • Must be able to provide informed consent

排除标准

  • Patients who require long term compression (active ulcers/ deep venous incompetence)
  • Patients who have already had one leg enrolled in the study
  • Patients with congenital venous malformations
  • Patients who require avulsions only
  • Patients who are unable to complete the questionnaires due to a lack of command over the language or who have vision/ hearing disabilities
  • Patients who are unable to attend the hospital for follow-up

研究组 & 干预措施

4 weeks & EVLT

No Intervention

After endovenous laser therapy and avulsions, patients will wear compression socks for four weeks (usual care)

4 weeks & RFA

No Intervention

After radiofrequency ablation therapy and avulsions, patients will wear compression socks for four weeks (usual care)

2 weeks & EVLT

Experimental

After endovenous laser therapy and avulsions, patients will wear compression socks for two weeks (trial group)

干预措施: Compression socks for 2 weeks (Other)

2 weeks & RFA

Experimental

After radiofrequency ablation therapy and avulsions, patients will wear compression socks for two weeks (trial group)

干预措施: Compression socks for 2 weeks (Other)

结局指标

主要结局

Pain Scores on the Visual Analog Scale

时间窗: Change from baseline at four weeks

次要结局

  • Quality of Life (Veins Related)(Change from baseline at four weeks)
  • Quality of Life (General)(Change from baseline at four weeks)

研究者

发起方
St. James's Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caitriona Canning

Fellow in Vascular Medicine

St. James's Hospital, Ireland

研究点 (2)

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