Evaluation of Naloxegol in the Prevention of POI After Cystectomy (NCT04219046) | Clinical Trial Compass
UnknownPhase 2
Evaluation of Naloxegol in the Prevention of POI After Cystectomy
102 participantsStarted 2021-03
Plain-language summary
Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after radical cystectomy. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs.
In order to optimize perioperative care for patients undergoing radical cystectomy in a context of an ERAS (Enhanced Recovery After Surgery) program, we will evaluate the effectiveness of systemic pharmacologic opioid antagonist treatment.
Who can participate
Age range
18 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:
* Patients aged ≥ 18 years
* Informed consent signed
* Histopathological confirmation of bladder cancer
* Patients undergoing radical cystectomy and urinary diversion for an oncological indication
* Patients able to understand the study procedures, agreed to participate in the study program
* Patients affiliated to the national "Social Security" regimen or beneficiary of this regimen
Exclusion Criteria:
* Unwilling to undergo cystectomy
* Cystectomy for non-oncological indication
* Patients with concomitant upper urinary tract disease
* Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
* Previous pelvic radiotherapy for prostate or bladder cancer
* Patients having taken opioids for more than seven days before surgery (to prevent peripheral withdrawal effects)
* Patients treated with drugs metabolized by certain enzymes (CYP3A4 and P-gp)
* Patients with severe hepatic impairment
* Patients with end-stage renal disease
* Patients with heart failure
* Patients with severe dementia that impacts daily functioning
* Pregnant and lactating females
* Not postmenopausal females and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm)
* Patients participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or me…
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.
What they're measuring
1
Time of hospital discharge
Timeframe: Date at which treatment is initiated and date of hospital discharge (up to 12 days)