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临床试验/NCT01181557
NCT01181557已完成不适用

Prospective Evaluation of Quality of Life in Patient With Rectal Cancer

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
1
主要终点
Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma

研究概览

简要总结

The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia.

Eligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.

详细描述

Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.

Outcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients

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

  • Rectal cancer

排除标准

  • Age younger than 18 years
  • History of psychiatric illness
  • Preoperative radiotherapy

结局指标

主要结局

Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma

时间窗: three month: first admission in hospital preoperative time

Two cohort in preoperative time: first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.

次要结局

  • Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma(Three months postoperative time)
  • Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma(Six months after postoperative time)

研究者

发起方
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
申办方类型
Other

研究点 (1)

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