Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhance… (NCT05611255) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS)
Stopped: Safety issue : increased occurrence of severe post-micturition residue (emergency urological consultation) for group B. The decision was taken on the advice of a committee of external experts
France21 participantsStarted 2022-12-08
Plain-language summary
General anesthesia, thoracic epidural, and morphine inhibit the urination process and promote postoperative Acute Urinary Retention (AUR) after thoracic surgery. Indwelling bladder catheterization prevents this risk, but is associated with other complications (urinary tract infection, delayed mobilization). With the rise of enhanced recovery after surgery (ERAS) protocols, bladder catheterization is being questioned. The current protocol in the department is to catheterize only patients with a high bladder volume in the post anesthesia care unit (defined as a bladder volume \> 400 ml on bladder scan). Preliminary results from the "AirLeaks" study show a high rate of early postoperative AUR (approximately 50%). The investigators believe that a "systematic intermittent catheterization" (SIC) strategy is superior to the current "bladder scan-guided catheterization in the post anesthesia care unit" (BSGC) strategy in preventing the risk of postoperative AUR. To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic accelerated rehabilitation protocol.
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:
* Undergoing scheduled thoracic surgery at the study center
* Be of legal age
* Be eligible for the enhanced recovery after surgery (ERAS) protocol in effect in the department.
Exclusion Criteria:
* Non-intubated anesthesia with spontaneous ventilation (NIVATS)
* Already have an indwelling bladder catheter or suprapubic catheter or double J catheter or other urinary drainage device
* Urinary tract infection under treatment or bladder catheterization less than one month old
* Indication of per- or postoperative bladder catheterization for another reason (e.g. monitoring of diuresis in chronic renal failure)
* Known vesico-sphincter disorder with documented post-void residue
* Neurological bladder (spinal cord injury or stroke sequelae)
* Documented urinary incontinence
* Chronic renal failure with a glomerular filtration rate (GFR) \< 30 ml/min
* Contraindication to bladder catheterization (e.g. stenosis of the urethra)
* Be under legal protection or incapable of giving consent
* Failure to obtain written informed consent after a reflection period
* Not be affiliated to a French social security system or a beneficiary of such a system
* Long-term morphine drugs
* Pregnancy in progress or planned during the study period, Pregnant or nursing women
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
Occurrence of acute urinary retention (AUR) within 24 hours postoperatively