Clinical trial NCT05611255: Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS)
Official title: Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS): Systematic Intermittent Catheterization Versus Bladder Scan Guided Catheterization in the Post Anesthesia Care Unit: a Prospective Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Retention
Chronic Kidney Infection
Urinary Infection
Keywords: Urinary catheter
Acute urinary retention
Thoracic surgery
Thoracic epidural
Enhanced Recovery After Surgery (ERAS)
Perioperative medicine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Acute urinary retention (AUR) is clinically defined by the presence of a bladder globe, with complete inability to urinate, sometimes associated with severe suprapubic abdominal pain. It is a urological emergency. An AUR can be complicated by acute renal failure, obstruction lifting syndrome (polyuria), a vacuo hematuria, or a slammed bladder (characterized by the presence of a post-void residue).

Systematic intermittent catheterization (SIC) allows monitoring of diuresis during the per- and post-operative period, and prevents the risk of AUR. It is associated with numerous disadvantages, such as the risk of infection (nosocomial urinary tract infection, bacteriuria, candiduria), which doubles after 2 days of catheterization, the risk of trauma (bleeding from the urethra, hematuria), the delay in mobilization and ambulation, and the psychological impact on the patients (dependence, agitation, confusion). All of these complications are potentially at risk of lengthening the average length of stay, and represent an additional cost for the Health Insurance. Thus, it seems that SIC is an obstacle to enhance recovery after surgery (ERAS), which is why the investigators have eliminated this option in our center. However, even recent American protocols for thoracic ERAS consider that an epidural should be associated with an indwelling catheter.

Bladder catheterization strategies are available for patients undergoing lung surgery. Options include no bladder catheterization, evacuation catheterization, and post anesthesia care unit catheterization guided by ultrasound or bladder scan measurement of bladder volume.

SIC is a strategy that involves draining urine once, in all patients, after surgery (in the operating room). Bladder Scan Guided Catheterization in the post anesthesia care unit (BSGC) is an innovative strategy that consists of a standardized and reproducible assessment of the bladder volume before discharge from the post anesthesia care unit, and draining urine only in patients who require it.

To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic ERAS protocol.

The hypothesis is that a SIC strategy is superior to an individualized BSGC strategy in preventing postoperative AUR in thoracic surgery patients entering a ERAS program.

The SIC strategy is a novel idea that is not yet widely used in ERAS programs. The investigators believe that the SIC strategy will significantly decrease the rate of AUR. If this strategy proves to be superior to our current "bladder scan guided" service protocol, it could be incorporated into our ERAS program. Knowing the clinical repercussions, psychological impact, and costs associated with postoperative AUR, the medico-economic prospects of this study are major.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of acute urinary retention (AUR) within 24 hours postoperatively
timeFrame: 24 hours after thoracic surgery
Secondary outcomes:
measure: Occurrence of acute urinary retention (AUR) after Day 1 and during the first 5 days after surgery or during the hospital stay
timeFrame: Between Day 1 and Day 5 postoperative
measure: Bladder volume drained
timeFrame: The first hour after catheter placement
measure: Total duration of the first bladder catheterization
timeFrame: During the first bladder catheterization
measure: Total number of bladder catheterizations
timeFrame: During the 5 days of post-surgical hospitalization
measure: The rate of complications related to catheterization
timeFrame: During the 5 days of post-surgical hospitalization
measure: The rate of complications related to AUR
timeFrame: During the 5 days of post-surgical hospitalization
measure: Other postoperative complications
timeFrame: During the 5 days of post-surgical hospitalization
measure: Duration before putting in the chair (in hours)
timeFrame: During the 5 days of post-surgical hospitalization
measure: Duration before standing up (in hours)
timeFrame: During the 5 days of post-surgical hospitalization
measure: Length of hospital stay
timeFrame: During the 5 days of post-surgical hospitalization
measure: Estimated cost of stay
timeFrame: During the 5 days of post-surgical hospitalization
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References: