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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04715308
Acronym
Pelvex 3
Enrollment
1200
Registered
2021-01-20
Start date
2020-12-01
Completion date
2022-03-01
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Participation, Patient Satisfaction, Quality of Life

Keywords

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

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.

Interventions

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

Sponsors

St Vincent's University Hospital, Ireland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration2 yearsMorbidity of urinary diversion/reconstruction
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-lifeBefore surgery and at 1, 3, 6, 9 and 12 months respectivelyPatient-reported outcomes assessing their quality-of-life

Secondary

MeasureTime frameDescription
To assess the longer-term complications associated with urinary diversion/reconstruction1 month - 12 monthsMorbidity of urinary diversion or reconstruction over longer than 1 month but less than 1 year
To measure the rate of reintervention for complications associated with urinary diversion/reconstruction12 monthsRate of reintervention

Countries

Ireland

Contacts

Primary ContactMatthew Fahy, MB
MFahy94@gmail.com00353874510237
Backup ContactMichael Kelly, MD
kellym11@tcd.ie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026