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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To measure the rate of reintervention for complications associated with urinary diversion/reconstruction |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort of patients who are undergoing surgery for locally advanced or recurrent rectal cancer and are undergoing a urinary diversion or reconstruction.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Fahy, MB | Contact | 00353874510237 | MFahy94@gmail.com | |
| Michael Kelly, MD | Contact | kellym11@tcd.ie |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Recruiting | Dublin | D4 | Ireland |
No individual patient date other than their responses to the questionnaire will be collected or shared.
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D010358 | Patient Participation |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D014547 | Urinary Diversion |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Rate of reintervention |
| 12 months |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |