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临床试验/NCT04715308
NCT04715308Unknown不适用

Surgical and Patient-entered Experiences Following Urinary Reconstruction After Pelvic Exenteration for Locally Advanced and Recurrent Rectal Cancer

St Vincent's University Hospital, Ireland1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
1
主要终点
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life

研究概览

简要总结

The outcomes of patients who undergo radical surgery for locally advanced and recurrent rectal cancer have improved vastly, but there is a lack of emphasis on the quality-of-life outcomes of these patients. This study will assess the patient experience of having a stoma for urinary diversion as part of surgery for advanced pelvic malignancy. This will be assessed at regular intervals both before and after surgery with the goal of increasing awareness of patient beliefs and concerns with regards to their stomas and to devise interventions that will improve their quality-of-life.

详细描述

Considerable progress has been made in the management of advanced and recurrent pelvic cancer over the last few decades. However, much emphasis has been placed on surgical and hospital-related outcomes. In recent years, there has been an increased focus on patient quality-of-life following major abdominopelvic surgery. However, there is a lack of updated evidence on how patients manage and perceive their stomas. Managing a stoma is a difficult task for patients and can adversely effect their quality-of-life. This study will investigate specifically the impact of managing a urostomy or ileal conduit. Patients will be contacted via an anonymized, opt-in SMS or email to answer a questionnaire, having previously been provided with a patient information leaflet. This will take approximately 5 minutes to complete and will be carried out just prior to and at 1, 3, 6, 9 and 12 months post-operatively. All of this data will be collated and published as part of a wider investigation in to patient quality-of-life following major abdominal and pelvic surgery. This study will be carried out in 35 countries.

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

  • Histologically-proven advanced rectal cancer
  • Has undergone urinary diversion/reconstruction
  • Aged 18 years or older
  • Able and willing to give written, informed consent
  • Able to access email/internet

排除标准

  • Strong evidence of metastatic or peritoneal disease
  • Palliative exenteration
  • Non-rectal origin of primary tumour
  • Colonic obstruction
  • Inability to answer online questionnaire

结局指标

主要结局

To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life

时间窗: Before surgery and at 1, 3, 6, 9 and 12 months respectively

Patient-reported outcomes assessing their quality-of-life

To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration

时间窗: 2 years

Morbidity of urinary diversion/reconstruction

次要结局

  • To measure the rate of reintervention for complications associated with urinary diversion/reconstruction(12 months)
  • To assess the longer-term complications associated with urinary diversion/reconstruction(1 month - 12 months)

研究者

发起方
St Vincent's University Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Des Winter

Professor Des C Winter, Consultant Gastronitestinal Surgeon

St Vincent's University Hospital, Ireland

研究点 (1)

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