Surgical and Patient-entered Experiences Following Urinary Reconstruction After Pelvic Exenteration for Locally Advanced and Recurrent Rectal Cancer
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
- 否
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
Professor Des Winter
Professor Des C Winter, Consultant Gastronitestinal Surgeon
St Vincent's University Hospital, Ireland
