Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Homerton University Hospital NHS Foundation Trust20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Anus Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Manometric indices

Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values

Time frame: Six months

Secondary Outcomes

Anal mucosal sensitivity

Changes in sensitivity as measured against patients own pre treatment perception

Time frame: 6 months

Endoanal ultrasound abnormalities

Changes in endoanal ultrasound abnormalities compared to pre-treatment findings

Time frame: 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

Time frame: 4 weeks 6 months

Patient reported outcomes

Patient reported outcomes, particularly with regard to sexual function and bowel function

Time frame: 6 months

Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts