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

NCT ID: NCT05611255

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2023-02-16

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.

Conditions

Urinary Retention; Chronic Kidney Infection; Urinary Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Systematic Intermittent Catheterization (SIC)

A bladder catheter will be placed in the operating room, at the end of the operation, in a patient still under general anesthesia. Once the urine has been drained and quantified, the bladder catheter will be removed before the patient is discharged and extubated.

Group Type: EXPERIMENTAL

Systematic Intermittent Catheterization

Intervention Type: PROCEDURE

A strategy that consists of draining urine only once, in all patients, after surgery (in the operating room).

Bladder Scan Guided Catheterization (BSGC)

No systematic catheterization will be performed, the indication for catheterization will be guided by bladder-scan volume monitoring.

Group Type: ACTIVE_COMPARATOR

Bladder Scan Guided Catheterization

Intervention Type: PROCEDURE

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.

Interventions

Systematic Intermittent Catheterization

A strategy that consists of draining urine only once, in all patients, after surgery (in the operating room).

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

SIC; BSGC

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0461

Identifier Type: -

Identifier Source: org_study_id