Function Following Laser for Anal Neoplasia (FLAN)
Research type
Research Study
Full title
Function following Laser for Anal Intraepithelial Neoplasia - a mixed methods feasibility study
IRAS ID
156771
Contact name
Tamzin Cuming
Contact email
Sponsor organisation
Homerton University Hospital Foundation NHS Trust
Duration of Study in the UK
1 years, 1 months, 28 days
Research summary
Anal intra-epithelial neoplasia (AIN) is recognised as a high risk disease that, if not treated, can progress to become anal cancer. Both AIN and anal cancer are becoming more common in HIV positive patients and in men who have sex with men (MSM). Long-term experience of treating AIN with laser has shown it removes AIN without major side effects. Laser treatment of AIN may also prevent it from progressing to become anal cancer. However, how laser treatment affects the function of the anus (ability to control bowel movement, avoid accidents/incontinence), and how undergoing laser treatment affects quality of life have not been studied before. This study is important because screening for AIN may be introduced in the future, and laser treatment suggested: the sexual preferences of some MSM may already have exposed them to damage to the back passage muscles (anal sphincters) and bowel function, and laser treatment to the anus may make it worse.
In this pilot study we will invite and recruit 20 HIV positive MSM patients recently diagnosed with AIN who have been recommended laser treatment. After full consent, patients will have anorectal physiology (ARP) and ultrasound scan tests before the laser treatment. Patients will fill in questionnaires relating to bowel function, sexual function and quality of life. The ARP tests and questionnaires will be repeated 4 weeks and 6 months after laser treatment. Detailed interviews will also be conducted at the same times after treatment. This will allow us to compare the effects of laser treatment on the function of anus before and after treatment in each participant, and explore the quality of life of patients after treatment. The results of this small study will help us to design a larger study to establish the full safety profile of laser treatment to the anus for AIN.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1432
Date of REC Opinion
24 Nov 2014
REC opinion
Further Information Favourable Opinion