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临床试验/NCT03462667
NCT03462667已完成不适用

Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年2月26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
65
试验地点
2
主要终点
Ostomy adjustment scale

研究概览

简要总结

The purpose of this study is to learn if the stoma boot camp is a good and effective way to help people adapt to life with a stoma after surgery.

详细描述

Bladder cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is a radical cystectomy (RC) with a urinary diversion. Patients that have this procedure must deal with a stoma that requires daily care and manual skills. A stoma is an artificial opening that allows urine to pass from the ureters outside the body. Having a surgery that results in a stoma can dramatically change a person's life.

This study is being done to test a new education session called the stoma boot camp. The session was created to help people deal with changes in their post-surgery life and living with a stoma.

The session requires a one time visit to the study site and lasts about two hours. Participants can bring a support person to the boot camp if they choose. During the two hour session, nurses will provide teaching, counseling, and hands on practice with an artificial stoma.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion
  • Diagnosis of bladder cancer

排除标准

  • Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate

结局指标

主要结局

Ostomy adjustment scale

时间窗: Change from Baseline to 30 Days After Date of Surgery

The Ostomy Adjustment Scale evaluates a person with an ostomy following surgery. The instrument consists of 34 statements. Scores range from a minimum of 34 to a maximum of 204. The higher the score, the better the person's perceived adjustment.

次要结局

  • Length of hospital stay(Date of Admission to Date of Discharge, up to 7 days)
  • Count of un-planned stoma-related interventions in community after discharge(30 Days After Date of Surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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