Pediatric Urology Recovery After Surgery Endeavor (PURSUE) (NCT03245242) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pediatric Urology Recovery After Surgery Endeavor (PURSUE)
United States85 participantsStarted 2017-04-01
Plain-language summary
The purpose of this research study is to evaluate an Enhanced Recovery After Surgery (ERAS) protocol in children and young adults undergoing urologic reconstructive surgery. The investigators plan to collect data on speed of recovery (how quickly pain improves, length of time in the hospital, and the need for additional pain control) on patients who receive care under the ERAS protocol and compare it to historical controls.
Who can participate
Age range
4 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Age greater than or equal to 4 or \<26 years at time of surgery
* Undergoing urologic reconstructive surgery that includes primary bowel anastomosis (i.e., creation of continent ileovesicostomy \[Monti\], sigmoid Monti channel, enterocystoplasty)
* Undergoing urologic reconstructive surgery that includes possible bowel anastomosis (planned creation of continent appendicovesicostomy \[Mitrofanoff\] with inability to use appendix at time of surgery and creation of alternative channel requiring primary bowel anastomosis)
Exclusion criteria:
• Clinically constipated (defined as Bristol 1 or 2 stools more than once per week, bowel movement interval \> every other day \[e.g. only has bowel movement every 3 days, or palpable stool in \> 50% of colon on physical preoperative exam)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.