Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer (Pelvex 3)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Patient Participation; Patient Satisfaction
• Intervention / Treatment: Procedure: Urinary diversion

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Matthew Fahy, MB; Phone Number: 00353874510237; Email: MFahy94@gmail.com
• Study Contact Backup: Name: Michael Kelly, MD; Email: kellym11@tcd.ie

Study Locations

• Ireland
  • Dublin, Ireland, D4
    • Recruiting
    • St. Vincent's Hospital
    • Contact: Des Winter, MD; Email: pelvexcollaborative@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort of patients who are undergoing surgery for locally advanced or recurrent rectal cancer and are undergoing a urinary diversion or reconstruction.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St Vincent's University Hospital, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Rectal cancer; Locally advanced and recurrent rectal cancer; Advanced pelvic cancer; Urinary diversion for rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: STVINCENTSIRELAND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual patient date other than their responses to the questionnaire will be collected or shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No