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Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

NCT04109573 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-31

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

high resolution anal manometry

functional studies before and after anal laser ablation

Sponsors & Collaborators

  • Barts & The London NHS Trust

    collaborator OTHER

  • Homerton University Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Tamzin Cuming, FRCS · Homerton University Hospital NHS Trust

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109573 on ClinicalTrials.gov