Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Manometric indices
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Manometric indices
时间窗: Six months
Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values
次要结局
- Anal mucosal sensitivity(6 months)
- Patient reported outcomes(6 months)
- Physical and psychological well-being(4 weeks 6 months)
- Endoanal ultrasound abnormalities(6 months)