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

NCT04715308 | Unknown

• 1 other identifier: STVINCENTSIRELAND
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction; Quality of Life; Patient Participation

Keywords

Rectal cancer; Locally advanced and recurrent rectal cancer; Advanced pelvic cancer; Urinary diversion for rectal cancer; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• To assess the longer-term complications associated with urinary diversion/reconstruction

  1 month - 12 months

• To measure the rate of reintervention for complications associated with urinary diversion/reconstruction

  12 months

Interventions

Urinary diversion PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Strong evidence of metastatic or peritoneal disease
• Palliative exenteration
• Non-rectal origin of primary tumour
• Colonic obstruction
• Inability to answer online questionnaire

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

Study Sites (1)

St. Vincent's Hospital

Dublin, D4, Ireland

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction; Patient Participation; Rectal Neoplasms

Interventions

Urinary Diversion

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Matthew Fahy, MB

CONTACT

00353874510237; MFahy94@gmail.com

Michael Kelly, MD

CONTACT

kellym11@tcd.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Des C Winter, Consultant Gastronitestinal Surgeon

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)