Reducing the discomfort of Varicose Vein Surgery

Phase 1

• Conditions: Superficial Venous Insufficiency; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2011-005574-39-GB
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-05
• Study Completion: 2015-01-30
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients aged 18 or over • Primary symptomatic superficial venous insufficiency, CEAP grades C2-C6 • SFJ and/or GSV reflux on DUS o Defined as retrograde flow = 1second in duration on spectral Doppler analysis • Suitable to undergo open surgical ligation of the SFJ and stripping of the GSV, with or without ambulatory phlebectomies. • Willing and able to participate and able to give valid, informed written consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

• Unsuitability to undergo surgery • Unwillingness/ inability to comply with the requirements for follow-up visits • Known allergy or contraindication to receive any constituents of the study anaesthesia • Varicose veins not due to SFJ or truncal GSV reflux • Pregnant/lactating women • Active Deep Venous Thrombosis/post-thrombotic syndrome of treatment leg • Active or recent (within last 6 weeks) thrombophlebitis of the treatment • Previous ipsilateral varicose vein treatment • Patients with impalpable foot pulses and Ankle-Brachial Pressure Index (ABPI) less than 0.8

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The principle research objective is to determine whether the addition of tumescent anaesthesia to conventional surgical ligation and stripping of the great saphenous vein results in less postoperative pain, than conventional surgery alone;Secondary Objective: The secondary research objectives are to see whether this new technique also has other benefits over conventional surgery, such as reduced requirements for pain-killers, less bruising and other complications, improved quality of life and quicker return to full activity.;Primary end point(s): The principal research objective is to assess whether the addition of tumescent anaesthesia to conventional surgery for varicose veins results in less pain, as determined by the bodily pain” domain of the SF36 questionnaire at 1 week.;Timepoint(s) of evaluation of this end point: One Week post procedure

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary outcomes cover a number of clinical and Quality of Life measures commonly utilised in the assessment of interventions for Varicose Veins:- 1. Patient-reported pain on 100mm Visual Analogue Scale (VAS), daily for the first post-operative week 2. Analgesia requirements for the first post-operative week 3. Severity of bruising assessed using 100mm VAS 4. Patient- and investigator-percieved bruising (on 100mm VAS) at one, six and twelve weeks 5. Incidence of haematoma formation 6. Generic and Disease-specific QoL at 1,6 and 12 weeks 7. Time to return to work/usual activities 8. Patient rating scales of overall satisfaction and cosmesis (100mm VAS);Timepoint(s) of evaluation of this end point: As outlined above