Clinical trial NCT04715308: Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer
Official title: Surgical and Patient-entered Experiences Following Urinary Reconstruction After Pelvic Exenteration for Locally Advanced and Recurrent Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration
timeFrame: 2 years
measure: To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life
timeFrame: Before surgery and at 1, 3, 6, 9 and 12 months respectively
Secondary outcomes:
measure: To assess the longer-term complications associated with urinary diversion/reconstruction
timeFrame: 1 month - 12 months
measure: To measure the rate of reintervention for complications associated with urinary diversion/reconstruction
timeFrame: 12 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Vincent's Hospital
Study officials:
References: