Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Study Overview
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Brief Summary
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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.

Detailed Description
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High resolution anoscopy with targeted laser ablation is one of the therapies currently employed to treat HSIL of the anus to prevent progression to anal cancer. The functional outcome of this procedure has not previously been formally assessed. HIV and negative positive MSM in whom HSIL has been detected will form the study population, as HSIL is prevalent in these patients and intervention is felt to be indicated. Functional assessments will be carried out prior to initial treatment and then repeated six months after laser ablation therapy. The structure, function and sensitivity of the anal canal will be evaluated using endoanal ultrasound, high-resolution anal manometry and anal mucosal electrosensitivity measurements respectively. Patient-reported outcomes will be assessed using questionnaires and semi-structured interviews at baseline, 4 weeks and 6 months post-treatment.

Official Title
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Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Conditions
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Anus Cancer, Fecal Incontinence, Anal Intraepithelial Neoplasia, Post Operative Pain

Intervention / Treatment
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* Procedure: high resolution anal manometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anorectal function post anal laser<br>Intervention: Device: laser | Procedure: high resolution anal manometry<br>* functional studies before and after anal laser ablation<br>* Other names: gastrointestinal physiology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manometric indices | Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal mucosal sensitivity | Changes in sensitivity as measured against patients own pre treatment perception | 6 months | 
| Endoanal ultrasound abnormalities | Changes in endoanal ultrasound abnormalities compared to pre-treatment findings | 6 months | 
| 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 | 
| Patient reported outcomes | Patient reported outcomes, particularly with regard to sexual function and bowel function | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser ablation, anal intraepithelial neoplasia, AIN, fecal incontinence, anal function