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

Last updated: February 6, 2021
Sponsor: St Vincent's University Hospital, Ireland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Rectal Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT04715308
STVINCENTSIRELAND
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 1200
Study Start date:
December 01, 2020
Estimated Completion Date:
March 01, 2022

Study 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.

Connect with a study center

  • St. Vincent's Hospital

    Dublin, D4
    Ireland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.