Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Sponsor

Homerton University Hospital NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04109573

Collaborator

Barts & The London NHS Trust (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anus Cancer Fecal Incontinence Anal Intraepithelial Neoplasia Post Operative Pain	Procedure: high resolution anal manometry	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Actual Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anorectal function post anal laser Intervention: Device: laser	Procedure: high resolution anal manometry functional studies before and after anal laser ablation Other Names: endoanal ultrasound gastrointestinal physiology

Arm

Intervention/Treatment

Experimental: Anorectal function post anal laser

Intervention: Device: laser

Procedure: high resolution anal manometry

functional studies before and after anal laser ablation

Other Names:

endoanal ultrasound

gastrointestinal physiology

Outcome Measures

Primary Outcome Measures

Manometric indices [Six months]
Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values

Secondary Outcome Measures

Anal mucosal sensitivity [6 months]
Changes in sensitivity as measured against patients own pre treatment perception
Endoanal ultrasound abnormalities [6 months]
Changes in endoanal ultrasound abnormalities compared to pre-treatment findings
Physical and psychological well-being [4 weeks 6 months]
Qualitative subjective physical and psychological well-being 4 weeks and 6 months after procedure of laser mucosal ablation of AIN
Patient reported outcomes [6 months]
Patient reported outcomes, particularly with regard to sexual function and bowel function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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