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

Primary Purpose

Anus Cancer, Fecal Incontinence, Anal Intraepithelial Neoplasia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
high resolution anal manometry
Sponsored by
Homerton University Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anus Cancer focused on measuring laser ablation, anal intraepithelial neoplasia, AIN, fecal incontinence, anal function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Homerton University Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anorectal function post anal laser

Arm Description

Intervention: Device: laser

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2016
Last Updated
August 25, 2021
Sponsor
Homerton University Hospital NHS Foundation Trust
Collaborators
Barts & The London NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04109573
Brief Title
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
Acronym
FLAN
Official Title
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Homerton University Hospital NHS Foundation Trust
Collaborators
Barts & The London NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anus Cancer, Fecal Incontinence, Anal Intraepithelial Neoplasia, Post Operative Pain
Keywords
laser ablation, anal intraepithelial neoplasia, AIN, fecal incontinence, anal function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anorectal function post anal laser
Arm Type
Experimental
Arm Description
Intervention: Device: laser
Intervention Type
Procedure
Intervention Name(s)
high resolution anal manometry
Other Intervention Name(s)
endoanal ultrasound, gastrointestinal physiology
Intervention Description
functional studies before and after anal laser ablation
Primary Outcome Measure Information:
Title
Manometric indices
Description
Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Anal mucosal sensitivity
Description
Changes in sensitivity as measured against patients own pre treatment perception
Time Frame
6 months
Title
Endoanal ultrasound abnormalities
Description
Changes in endoanal ultrasound abnormalities compared to pre-treatment findings
Time Frame
6 months
Title
Physical and psychological well-being
Description
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
Title
Patient reported outcomes
Description
Patient reported outcomes, particularly with regard to sexual function and bowel function
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamzin Cuming, FRCS
Phone
02085105555
Email
Tamzin.cuming@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Inwang, MSc
Phone
02085105134
Email
christine.mitchell-inwang@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamzin Cuming, FRCS
Organizational Affiliation
Homerton University Hospital NHS Trust
Official's Role
Study Director
Facility Information:
Facility Name
Homerton University Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamzin Cuming, FRCS, MBBS
Phone
02085105555
Email
tamzin.cuming@nhs.net
First Name & Middle Initial & Last Name & Degree
Mayura Nathan, FRCS
Phone
02085105555
Ext
7979
Email
mayura.nathan@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

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