Patient SatisfactionPelvex 3NCT04715308
Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer
An observational study of Patient Satisfaction and Quality of Life, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Quality of Life, Patient Participation
- What is being tested?
- Urinary diversion
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteIreland
- Study dates
- 1 Dec 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of patients who are undergoing surgery for locally advanced or recurrent rectal cancer and are undergoing a urinary diversion or reconstruction.
Who may be able to join
- 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
Who cannot join
- Strong evidence of metastatic or peritoneal disease
- Palliative exenteration
- Non-rectal origin of primary tumour
- Colonic obstruction
- Inability to answer online questionnaire
Trial locations and contacts
1 site in 1 country.
Michael Kelly, MD contact
Ireland1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Dublin, D4
Des Winter, MD, pelvexcollaborative@gmail.com
About this study
Official title: Surgical and Patient-entered Experiences Following Urinary Reconstruction After Pelvic Exenteration for Locally Advanced and Recurrent Rectal Cancer
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.
Read the 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.
- Conditions
- Patient Satisfaction, Quality of Life, Patient Participation
- Being tested
- Urinary diversion
- Keywords
- Rectal cancer, Locally advanced and recurrent rectal cancer, Advanced pelvic cancer, Urinary diversion for rectal cancer, Quality of life
- Medical subject headings
- Patient Satisfaction, Patient Participation, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary diversionProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration
Morbidity of urinary diversion/reconstruction
Measured: 2 years
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life
Patient-reported outcomes assessing their quality-of-life
Measured: Before surgery and at 1, 3, 6, 9 and 12 months respectively
Secondary outcomes (2)
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
Measured: 1 month - 12 months
To measure the rate of reintervention for complications associated with urinary diversion/reconstruction
Rate of reintervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Des Winter, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715308
- Sponsor's protocol ID
- STVINCENTSIRELAND
- Acronym
- Pelvex 3
- Status last verified
- Feb 2021
- First submitted
- 14 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient date other than their responses to the questionnaire will be collected or shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Patient-entered Experiences Following Urinary Reconstruction After Pelvic Exenteration for Locally Advanced and Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT04715308
- Acronym / sponsor ID
- Pelvex 3 / STVINCENTSIRELAND
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients who are undergoing surgery for locally advanced or recurrent rectal cancer and are undergoing a urinary diversion or reconstruction.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Strong evidence of metastatic or peritoneal disease
- Palliative exenteration
- Non-rectal origin of primary tumour
- Colonic obstruction
- Inability to answer online questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary diversionThe 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 | Procedure or surgery | – |
Primary outcome
To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration
Time frame: 2 years
Morbidity of urinary diversion/reconstruction
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life
Time frame: Before surgery and at 1, 3, 6, 9 and 12 months respectively
Patient-reported outcomes assessing their quality-of-life
2 secondary outcomes
To assess the longer-term complications associated with urinary diversion/reconstruction
Time frame: 1 month - 12 months
To measure the rate of reintervention for complications associated with urinary diversion/reconstruction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No. No individual patient date other than their responses to the questionnaire will be collected or shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kelly, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Quality of Life, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Fahy, MB (00353874510237, MFahy94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.