E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Superficial Venous Insufficiency |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Clinical outcomes when utilising the tumescent infiltration technique |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
No infiltration in control group |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |