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临床试验/NCT04350112
NCT04350112已完成不适用

An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain

Royal Surrey County Hospital NHS Foundation Trust16 个研究点 分布在 1 个国家目标入组 1,007 人开始时间: 2017年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,007
试验地点
16
主要终点
Prevalence of opioid-induced constipation

研究概览

简要总结

The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer.

The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.

详细描述

StOIC-1 is an observational study, and will involve a single visit (see below for schedule).

The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug, formulation, dose; e) other medications; f) Eastern Co-operative Oncology Group performance status

The participants will be asked the following questions:

  1. Simple question - "Are you constipated?" [Options - yes / no / unsure]
  2. European Association for Palliative Care definition question - "Does the following question describe your bowel function: 'the passage of small, hard faeces infrequently and with difficulty?' [Options - yes / no / unsure]
  3. Camilleri definition question - "Does the following statement describe your bowel function: 'a change since initiating opioid therapy from baseline bowel habits that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, harder stool consistency?' [Options - yes / no / unsure
  4. Rome IV diagnostic criteria for OIC

The participants will also be asked to complete:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Age > 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week

排除标准

  • Inability to give informed consent; inability to complete questionnaire

结局指标

主要结局

Prevalence of opioid-induced constipation

时间窗: 1 week

Clinician assessment

次要结局

未报告次要终点

研究者

发起方
Royal Surrey County Hospital NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (16)

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