Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS)

Urinary Retention Clinical Trial

— URICATHOR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611255
• Other study ID #: RECHMPL20_0461
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: June 8, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Jérôme PANIEGO, IADE
• Phone: 0664439476
• Email: j-paniego[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 8, 2024
• Est. primary completion date: June 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Infection
• Urinary Retention
• Urinary Tract Infections

Intervention

Procedure:
• Systematic Intermittent Catheterization
A strategy that consists of draining urine only once, in all patients, after surgery (in the operating room).
• Bladder Scan Guided Catheterization
A strategy of standardized and reproducible assessment of bladder volume before discharge from the post anesthesia care unit, and draining urine only in patients who require it.

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of acute urinary retention (AUR) within 24 hours postoperatively	AUR is defined by the absence of voiding recovery in an unprobed patient, with or without pubic pain (pain may be inhibited by epidural or morphine received), associated with a bladder volume > 400 ml on bladder scan.	24 hours after thoracic surgery
Secondary	Occurrence of acute urinary retention (AUR) after Day 1 and during the first 5 days after surgery or during the hospital stay	Compare the rate of AUR occurring beyond the 24th postoperative hour between the two groups.	Between Day 1 and Day 5 postoperative
Secondary	Bladder volume drained	Bladder volume drained the first hour after catheter placement	The first hour after catheter placement
Secondary	Total duration of the first bladder catheterization	Total duration of the first bladder catheterization	During the first bladder catheterization
Secondary	Total number of bladder catheterizations	Total number of bladder catheterizations	During the 5 days of post-surgical hospitalization
Secondary	The rate of complications related to catheterization	Macroscopic hematuria, documented urinary tract infection, suspected urinary tract infection with probabilistic antibiotic treatment.	During the 5 days of post-surgical hospitalization
Secondary	The rate of complications related to AUR	Postoperative acute renal failure	During the 5 days of post-surgical hospitalization
Secondary	Other postoperative complications	Postoperative hypotension, nausea or vomiting.	During the 5 days of post-surgical hospitalization
Secondary	Duration before putting in the chair (in hours)	Duration before putting in the chair (in hours)	During the 5 days of post-surgical hospitalization
Secondary	Duration before standing up (in hours)	Duration before standing up (in hours)	During the 5 days of post-surgical hospitalization
Secondary	Length of hospital stay	Length of hospital stay	During the 5 days of post-surgical hospitalization
Secondary	Estimated cost of stay	Estimated cost of stay	During the 5 days of post-surgical hospitalization