A double-blind randomised controlled trial comparing porcine dermal collagen patch saphenoplasty with conventional saphenofermoral ligation to prevent recurrent saphenofemoral incompetence
| ISRCTN | ISRCTN43505974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43505974 |
| Secondary identifying numbers | 6006 |
- Submission date
- 21/10/2010
- Registration date
- 21/10/2010
- Last edited
- 18/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof A K Samy
Scientific
Scientific
Diana, Princess of Wales Hospital
Scartho Road
Grimsby
DN33 2BA
United Kingdom
Study information
| Study design | Multicentre non-randomised observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A double-blind randomised controlled trial comparing porcine dermal collagen patch saphenoplasty with conventional saphenofermoral ligation to prevent recurrent saphenofemoral incompetence |
| Study objectives | 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 Permacol™ in this setting, and shall use the following endpoints to test the given null hypothesis. |
| Ethics approval(s) | MREC approved, ref: 06/Q1105/27 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/07/2006 |
| Completion date | 09/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 100 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/07/2006 |
| Date of final enrolment | 09/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diana, Princess of Wales Hospital
Grimsby
DN33 2BA
United Kingdom
DN33 2BA
United Kingdom
Sponsor information
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
England
United Kingdom
| Website | http://www.nlg.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01ep18d71 |
Funders
Funder type
Industry
Tissue Science Laboratories PLC (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/04/2017: No publications found, verifying study status with principal investigator.
