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临床试验/NCT02884076
NCT02884076已完成不适用

Validating the Ability of the Sodergren Score to Guide Management of Symptomatic Haemorrhoids in a Malaysian Population

University of Malaya1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Method of treatment

研究概览

简要总结

To validate the ability of the Sodergren score in guiding the management of symptomatic haemorrhoids in a Malaysian population.

详细描述

All participating, consented subjects will be scored with the Sodergren score prior to receiving a standardized ambulatory treatment regime. The questionnaire will be self-administered by the subjects. Subjects whom are not able to self-administer the questionnaire will be assisted by the investigator or research assistant. The nature and severity of the subject's haemorrhoidal symptoms are considered as the pre-treatment baseline. A follow up period of 12 months will be carried out post treatment for failure or success of treatment. The data collected will be compared to pre-treatment scores and analyzed statistically.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age and older
  • Male and female genders
  • Previous ambulatory treatment
  • Internal Haemorrhoids

排除标准

  • Presence of external haemorrhoids
  • Prior haemorrhoidal surgery
  • Anti-coagulant therapy
  • Anal fissure
  • Inflammatory bowel disease
  • Underlying colon-rectal malignancy

结局指标

主要结局

Method of treatment

时间窗: 12 months

Surgery or ambulatory treatment of hemorrhoid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Galen Sha

Dr

University of Malaya

研究点 (1)

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