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

NCT05611255 | Terminated

• 1 other identifier: RECHMPL20_0461
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Occurrence of acute urinary retention (AUR) after Day 1 and during the first 5 days after surgery or during the hospital stay

  Between Day 1 and Day 5 postoperative

• Bladder volume drained

  The first hour after catheter placement

• Total duration of the first bladder catheterization

  During the first bladder catheterization

• Total number of bladder catheterizations

  During the 5 days of post-surgical hospitalization

• The rate of complications related to catheterization

  During the 5 days of post-surgical hospitalization

Study Arms (2)

Systematic Intermittent Catheterization (SIC)

EXPERIMENTAL

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.

Procedure: Systematic Intermittent Catheterization

Bladder Scan Guided Catheterization (BSGC)

ACTIVE COMPARATOR

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

Procedure: Bladder Scan Guided Catheterization

Interventions

Systematic Intermittent Catheterization PROCEDURE

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

Also known as: SIC

Systematic Intermittent Catheterization (SIC)

Bladder Scan Guided Catheterization 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.

Also known as: BSGC

Bladder Scan Guided Catheterization (BSGC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Urinary Retention; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 10, 2022
• Study Start: December 8, 2022
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)