Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery

NCT02676908 | Unknown

• 1 other identifier: SJH-01-VV
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicose Veins

Keywords

endovenous ablation; laser; radiofrequency; stockings

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Visual Analog Scale

  Change from baseline at four weeks

Secondary Outcomes (2)

• Quality of Life (Veins Related)

  Change from baseline at four weeks

• Quality of Life (General)

  Change from baseline at four weeks

Study Arms (4)

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)

Other: Compression socks for 2 weeks

2 weeks & RFA

EXPERIMENTAL

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

Other: Compression socks for 2 weeks

Interventions

Compression socks for 2 weeks OTHER

Patients in the intervention group will be asked to wear compression stockings for two weeks post-operatively

2 weeks & EVLT; 2 weeks & RFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead

Study Sites (1)

St James's Hospital

Dublin, 8, Ireland

RECRUITING

Related Publications (2)

• Bakker NA, Schieven LW, Bruins RM, van den Berg M, Hissink RJ. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg. 2013 Nov;46(5):588-92. doi: 10.1016/j.ejvs.2013.08.001. Epub 2013 Sep 5.

  PMID: 24012465 BACKGROUND

• Krasznai AG, Sigterman TA, Troquay S, Houtermans-Auckel JP, Snoeijs M, Rensma HG, Sikkink C, Bouwman LH. A randomised controlled trial comparing compression therapy after radiofrequency ablation for primary great saphenous vein incompetence. Phlebology. 2016 Mar;31(2):118-24. doi: 10.1177/0268355514568658. Epub 2015 Jan 23.

  PMID: 25616874 BACKGROUND

Related Links

• Elderman JH, Krasznai AG, Voogd AC, Hulsewé KWE, Sikkink CJJM. Role of compression stockings after endovenous laser therapy for primary varicosis. JVS Venous and Lymphatic Disorders. 2014 2(3): 289-296

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Vascular Medicine

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: February 8, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)