Condition category
Surgery
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
28/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof A K Samy

ORCID ID

Contact details

Diana
Princess of Wales Hospital
Scartho Road
Grimsby
DN33 2BA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6006

Study information

Scientific title

Acronym

Study hypothesis

The study aims to compare the use of porcine dermal collagen patch saphenoplasty with standard saphenofemoral flush ligation in primary and recurrent varicose vein surgery. Post-operative subjective and objective measures of presence and severity of varicosity recurrence shall be compared. This shall be the first study to establish the efficacy of Permacolâ„¢ in this setting, and shall use the following endpoints to test the given null hypothesis.

Ethics approval

MREC approved, ref: 06/Q1105/27

Study design

Multicentre non-randomised observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Condition

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

Intervention

1. Imaging investigations (non-radiation): Patients need to undergo a handheld Doppler ultrasound examination of the saphenofemoral junction to document the presence of radiologically apparent recurrence.
2. Other examinations: Patients shall be clinically examined for evidence of recurrent varicose veins
3. Questionnaire: A research nurse assessor, blinded to the technique used, shall administer a questionnaire at 1 and 5 years follow-up

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

10/07/2006

Overall trial end date

09/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/07/2006

Recruitment end date

09/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diana, Princess of Wales Hospital
Grimsby
DN33 2BA
United Kingdom

Sponsor information

Organisation

Northern Lincolnshire and Goole Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Sponsor type

Government

Website

http://www.nlg.nhs.uk

Funders

Funder type

Industry

Funder name

Tissue Science Laboratories PLC (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes