Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Patient Satisfaction, Quality of Life, Patient Participation

Intervention / Treatment
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* Procedure: Urinary diversion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Strong evidence of metastatic or peritoneal disease Palliative exenteration Non-rectal origin of primary tumour Colonic obstruction Inability to answer online questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Urinary diversion|The formation of a stoma to divert urine to the skin because of the need to resect the bladder as part of surgery for advanced pelvic malignancy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration | Morbidity of urinary diversion/reconstruction | 2 years | 
| To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life | Patient-reported outcomes assessing their quality-of-life | Before surgery and at 1, 3, 6, 9 and 12 months respectively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the longer-term complications associated with urinary diversion/reconstruction | Morbidity of urinary diversion or reconstruction over longer than 1 month but less than 1 year | 1 month - 12 months | 
| To measure the rate of reintervention for complications associated with urinary diversion/reconstruction | Rate of reintervention | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Locally advanced and recurrent rectal cancer, Advanced pelvic cancer, Urinary diversion for rectal cancer, Quality of life