Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Post Operative Pain Clinical Trial

— FLAN  

Official title:

Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109573
• Other study ID #: R&DCL1403
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Homerton University Hospital NHS Foundation Trust
• Contact: Tamzin Cuming, FRCS
• Phone: 02085105555
• Email: Tamzin.cuming[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anal Intraepithelial Neoplasia
• Anus Cancer
• Anus Neoplasms
• Carcinoma in Situ
• Fecal Incontinence
• Neoplasms
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• high resolution anal manometry
functional studies before and after anal laser ablation

Locations

Country	Name	City	State
United Kingdom	Homerton University Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Homerton University Hospital NHS Foundation Trust	Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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