Post Operative Pain Clinical Trial
— FLANOfficial title:
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
NCT number | NCT04109573 |
Other study ID # | R&DCL1403 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | December 2022 |
High-grade squamous intraepithelial lesions (HSIL) and anal cancer are rising in incidence and at highest risk are HIV positive men who have sex with men (MSM). This pilot study assessing anal function and patient-reported outcomes before and after laser ablation of HSIL will add to the evidence that such a therapy is an acceptable and safe treatment to offer in a preventative setting.We will be recruting HIV positive and negative MSM.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: MSM >18 years of age if HIV positive, CD4 count of over 350; if less, been on highly active antiretroviral treatment for at least 3 months Histologically proven high-grade squamous anal intraepithelial neoplasia lesion (HSIL) Anal canal disease with or without perianal disease Written informed consent Exclusion Criteria: Previous laser or other ablative treatment for HSIL (previous topical treatment is not excluded) Any treatment for HSIL in the previous six months Previous or current diagnosis of anal cancer Concurrent or previous (if severe) perianal inflammatory bowel disease, complex fistula or other significant perianal condition requiring surgery including fissures, current fistula in ano and Grade III or IV haemorrhoids Perianal sepsis Perianal disease only without anal canal HSIL |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Homerton University Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Homerton University Hospital NHS Foundation Trust | Barts & The London NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Manometric indices | Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values | Six months | |
Secondary | Anal mucosal sensitivity | Changes in sensitivity as measured against patients own pre treatment perception | 6 months | |
Secondary | Endoanal ultrasound abnormalities | Changes in endoanal ultrasound abnormalities compared to pre-treatment findings | 6 months | |
Secondary | Physical and psychological well-being | Qualitative subjective physical and psychological well-being 4 weeks and 6 months after procedure of laser mucosal ablation of AIN | 4 weeks 6 months | |
Secondary | Patient reported outcomes | Patient reported outcomes, particularly with regard to sexual function and bowel function | 6 months |
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