Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter … (NCT04070898) | Clinical Trial Compass
UnknownNot Applicable
Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.
Spain416 participantsStarted 2019-09-15
Plain-language summary
INTRODUCTION: Recommendations for peroperative bladder catheterization remain a controversial issue since it is a procedure that is not without complications. Most of the current suggestions derive from open surgery data that have been extrapolated to Enhanced Recovery After Surgery (ERAS) or Fast-Track programs ranging between 24-48 hours.
The objective of the present study is to find the perfect balance with a better degree of evidence than the current one between the reduction of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery.
Methods: Multicenter, prospective, controlled, randomized non-inferiority study on the management of the bladder catheter in patients undergoing scheduled laparoscopic colon surgery, randomized in two study groups: experimental group (removal of the bladder catheter after surgery ) and control group (removal of the catheter at 24 hours) after the surgical intervention.
The main objective of the present study is to reduce the permanence of the bladder catheter trying to find the balance of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter.
Who can participate
Age range
18 Years – 100 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:
* Any patient who understands, agrees to participate and signs the informed consent
* older than 18 years-old
* electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened
* duration of the surgical act less than 180 minutes
* Prior anesthetic assessment of ASA I-III
* International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker).
Exclusion Criteria:
* \- Open surgery or conversion to open surgery
* Performing periodic anesthesia or being ASA IV
* Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months);
* Moderate-severe prostate clinic (IPSS\> 19)
* Presence of positive urine culture in men in preoperative tests
* Urinary infection clinic in women with positive urine culture
* Previous history of acute urine retention
* be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization.
* men who underwent prostate surgery
* patients with a history of treatment for urological tumor - patients with a history of urethral stricture, enterovesical fistula or previous pelvic surgery.
* urinary incontinence or neurogenic bladder
* chronic renal failure (CRF) with creatinine levels greater than 2 (including terminal CRI stage or dialysis)
* emergency surgery pregnant
* have received pelvic radiothe…
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
Development of acute urine retention after removal of the bladder catheter after colon surgery.