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临床试验/NCT04375930
NCT04375930已完成不适用

The Effect of Standard-Based Care on Peristomal Skin Complications and Quality of Life in Ostomy Creation Patients With Colorectal Cancer

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Rate of Peristomal skin complication change

研究概览

简要总结

This study is a single blind semi-experimental study.

Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.

H1: Standard stoma care which is established evidence-based guides and complication algorithm, reduces peristomal skin complications in patients with colorectal cancer and an ostomy.

H2: Standard stoma care which is established evidence-based guides and complication algorithm, increases the quality of life in patients with colorectal cancer and an ostomy.

详细描述

In order to ensure blindness in the study design, patients were not informed about which group they belonged to.

Patient with ostomy in the study group were trained in accordance with the Standard Stoma Care.

Patient with ostomy in the control group only skill and discharge training has been provided in accordance with the hospital procedure.

All patients were followed up at 2, 6, and 12 weeks. Peristomal complications were evaluated by the researcher with the Peristomal Skin Tool at the 2nd, 6th and 12th weeks. The patients were asked to fill the Stoma Quality of Life Scale in the 2nd, 6th and 12th weeks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The patients with an ostomy were blinded.

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

  • undergoing colorectal surgery,
  • permanent or temporary ileostomy or colostomy
  • end or loop ileostomy or colostomy

排除标准

  • individuals who have previously had stoma surgery,
  • having two or more stoma,
  • individuals with crohn's disease
  • individuals who do not want to participate in the study

结局指标

主要结局

Rate of Peristomal skin complication change

时间窗: 0, 2nd, 6th and 12th weeks

It has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.

means of quality of life change

时间窗: 2nd, 6th and 12th weeks

It has been assessed with stoma Quality of Life Scale. The Scale range: 0-100. Higher scores for each item indicate that the quality of life increased.

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

Cahide AYİK

Research assistant

Dokuz Eylul University

研究点 (2)

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