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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04715308
Other study ID # STVINCENTSIRELAND
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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