A double-blind randomised controlled trial comparing porcine dermal collagen patch saphenoplasty with conventional saphenofermoral ligation to prevent recurrent saphenofemoral incompetence

Not Applicable

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery; Surgery; Varicose vein

• Registration Number: ISRCTN43505974
• Lead Sponsor: orthern Lincolnshire and Goole Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-21
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Not provided at time of registration

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
50% reduction in the clinical presence of recurrence at 5 years.

Secondary Outcome Measures

Name	Time	Method
1. Annual clinical recurrence rates<br>2. Local complication rate - fistula, haematoma, groin wound infection<br>3. Radiographically demonstrable recurrence rates at 1 year and 5 years<br>4. Serious adverse event rates<br>5. 36-item short form health survey (SF-36) and EUROQOL questionnaire scores<br>6. Visual analogue pain scores