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

Quality of Life Clinical Trial

— Pelvex 3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715308
• Other study ID #: STVINCENTSIRELAND
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2021
• Source: St Vincent's University Hospital, Ireland
• Contact: Matthew Fahy, MB
• Phone: 00353874510237
• Email: MFahy94[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Participation
• Patient Satisfaction
• Quality of Life
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Ireland	St. Vincent's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's University Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration	Morbidity of urinary diversion/reconstruction	2 years
Primary	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	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
Secondary	To measure the rate of reintervention for complications associated with urinary diversion/reconstruction	Rate of reintervention	12 months