NCT04109573

Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Homerton University Hospital NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anus Cancer
• Fecal Incontinence
• Anal Intraepithelial Neoplasia
• Post Operative Pain

Interventions

Type	Name	Description
PROCEDURE	high resolution anal manometry	functional studies before and after anal laser ablation

Timeline

• Start date: 2018-03-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-09-30
• Last updated: 2021-08-31

Locations

1 site across 1 country: United Kingdom