An observational study in Patient Satisfaction, Quality of Life and Patient Participation, sponsored by St Vincent's University Hospital, Ireland. Status unknown at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by St Vincent's University Hospital, Ireland · Observational
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →St Vincent's University Hospital, Ireland is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort of patients who are undergoing surgery for locally advanced or recurrent rectal cancer and are undergoing a urinary diversion or reconstruction.
Exclusion Criteria:
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
To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration
Morbidity of urinary diversion/reconstruction
Time frame: 2 years
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life
Patient-reported outcomes assessing their quality-of-life
Time frame: Before surgery and at 1, 3, 6, 9 and 12 months respectively
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
Time frame: 1 month - 12 months
To measure the rate of reintervention for complications associated with urinary diversion/reconstruction
Rate of reintervention
Time frame: 12 months
Plan to share: No — No individual patient date other than their responses to the questionnaire will be collected or shared.
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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St Vincent's University Hospital, Ireland