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

• Conditions: Patient Satisfaction; Patient Participation; Quality of Life

• Registration Number: NCT04715308
• Lead Sponsor: St Vincent's University Hospital, Ireland

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-06
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life	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	2 years	Morbidity of urinary diversion/reconstruction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇮🇪 Dublin, Ireland