Feasibilty study on HELICA ablative treatment for VAIN
Research type
Research Study
Full title
Feasibilty study for HELICA ablation for the treatment of VAIN
IRAS ID
204223
Contact name
jonathan pepper
Contact email
Sponsor organisation
walsall manor hospital
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Vaginal intrepithelial neoplasia (VAIN) is a pre-malignancy condition caused mainly by HPV, similar to CIN on the cervix. The best treatment of patients with this condition is unknown. Surgery including vaginectomy can be associated with multiple co-morbidities. Destructive treatment with laser is expensive and not available in every unit. Diathermy can be performed under GA but there is no robust evidence on its efficacy and safety. Destructive treatment is associated with high level of relapse (up to 30% within 6 months).
HELICA treatment has a recognised place in the treatment of many surgical conditions and has an excellent safety profile. There is evidence that HELICA treatment is useful for treating oral HPV premalignant conditions. We would like to determine if it is feasible to use the HELICA to treat VAIN patients in the future. To do this we need to measure the depth of tissue destruction on vaginal skin by HELICA.
Patients who are undergoing routine vaginal prolapse repairs have excess vaginal skin removed and thrown away. This 'dead' or waste tissue can be used and ablated with HELICA and then histologically measure depth of tissue destruction. We propose using the 'dead' tissue from 10 patients undergoing prolapse repairs as multiple areas on each bit of skin removed can be ablated for analysis. Any patient volunteering to let us use the tissue will in no way have her management changed as removing the skin is a routine part of the procedure.
The results from this study would tell us if HELICA has the potential to be used on patients who have the condition.REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/0733
Date of REC Opinion
15 Jun 2016
REC opinion
Further Information Favourable Opinion