Avulsion or ligation - small tributaries of long saphenous vein in groin, does it really matter?
| ISRCTN | ISRCTN57635230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57635230 |
| Protocol serial number | N0557093656 |
| Sponsor | Department of Health (UK) |
| Funder | The Dudley Group of Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Mr Ajantha P Jayatunga
Scientific
Scientific
Consultant General Surgeon
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Avulsion or ligation - small tributaries of long saphenous vein in groin, does it really matter? |
| Study objectives | Simple avulsion rather than ligation of the small tributaries of the long saphenous vein in the groin reduces time for groin surgery, causes no more pain and produces no increase in the incidence of groin haematoma. Does avulsion rather than ligation of small tributaries reduce the incidence of recurrence? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Long saphenous vein |
| Intervention | Randomised controlled trial - envelope opened by anaesthetist after patient is anaesthetised for operation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Groin bruising or haematoma; sign of infection; pain; other adverse events - proforma to be filled in by single nursing sister who is 'blinded' to the patient's randomisation group. Follow up at 24 h and 1 week by nurse. Surgeon sees patient for 6 and 12 month follow up to check for recurrence in groin (avulsion reduces incidence of groin recurrence). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | Patients with saphenous vein junction incompetence |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/08/1999 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
DY1 2HQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/02/2018: No publications found, verifying study status with principal investigator.
26/01/2016: no publications found on PubMed.
