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

Primary Purpose

Urinary Retention, Chronic Kidney Infection, Urinary Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Systematic Intermittent Catheterization
Bladder Scan Guided Catheterization
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Retention focused on measuring Urinary catheter, Acute urinary retention, Thoracic surgery, Thoracic epidural, Enhanced Recovery After Surgery (ERAS), Perioperative medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Systematic Intermittent Catheterization (SIC)

Bladder Scan Guided Catheterization (BSGC)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Bladder volume drained
Bladder volume drained the first hour after catheter placement
Total duration of the first bladder catheterization
Total duration of the first bladder catheterization
Total number of bladder catheterizations
Total number of bladder catheterizations
The rate of complications related to catheterization
Macroscopic hematuria, documented urinary tract infection, suspected urinary tract infection with probabilistic antibiotic treatment.
The rate of complications related to AUR
Postoperative acute renal failure
Other postoperative complications
Postoperative hypotension, nausea or vomiting.
Duration before putting in the chair (in hours)
Duration before putting in the chair (in hours)
Duration before standing up (in hours)
Duration before standing up (in hours)
Length of hospital stay
Length of hospital stay
Estimated cost of stay
Estimated cost of stay

Full Information

First Posted
October 10, 2022
Last Updated
April 14, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05611255
Brief Title
Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
June 8, 2024 (Anticipated)
Study Completion Date
June 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Chronic Kidney Infection, Urinary Infection
Keywords
Urinary catheter, Acute urinary retention, Thoracic surgery, Thoracic epidural, Enhanced Recovery After Surgery (ERAS), Perioperative medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Double blind
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systematic Intermittent Catheterization (SIC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Bladder Scan Guided Catheterization (BSGC)
Arm Type
Active Comparator
Arm Description
No systematic catheterization will be performed, the indication for catheterization will be guided by bladder-scan volume monitoring.
Intervention Type
Procedure
Intervention Name(s)
Systematic Intermittent Catheterization
Other Intervention Name(s)
SIC
Intervention Description
A strategy that consists of draining urine only once, in all patients, after surgery (in the operating room).
Intervention Type
Procedure
Intervention Name(s)
Bladder Scan Guided Catheterization
Other Intervention Name(s)
BSGC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of acute urinary retention (AUR) within 24 hours postoperatively
Description
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.
Time Frame
24 hours after thoracic surgery
Secondary Outcome Measure Information:
Title
Occurrence of acute urinary retention (AUR) after Day 1 and during the first 5 days after surgery or during the hospital stay
Description
Compare the rate of AUR occurring beyond the 24th postoperative hour between the two groups.
Time Frame
Between Day 1 and Day 5 postoperative
Title
Bladder volume drained
Description
Bladder volume drained the first hour after catheter placement
Time Frame
The first hour after catheter placement
Title
Total duration of the first bladder catheterization
Description
Total duration of the first bladder catheterization
Time Frame
During the first bladder catheterization
Title
Total number of bladder catheterizations
Description
Total number of bladder catheterizations
Time Frame
During the 5 days of post-surgical hospitalization
Title
The rate of complications related to catheterization
Description
Macroscopic hematuria, documented urinary tract infection, suspected urinary tract infection with probabilistic antibiotic treatment.
Time Frame
During the 5 days of post-surgical hospitalization
Title
The rate of complications related to AUR
Description
Postoperative acute renal failure
Time Frame
During the 5 days of post-surgical hospitalization
Title
Other postoperative complications
Description
Postoperative hypotension, nausea or vomiting.
Time Frame
During the 5 days of post-surgical hospitalization
Title
Duration before putting in the chair (in hours)
Description
Duration before putting in the chair (in hours)
Time Frame
During the 5 days of post-surgical hospitalization
Title
Duration before standing up (in hours)
Description
Duration before standing up (in hours)
Time Frame
During the 5 days of post-surgical hospitalization
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
During the 5 days of post-surgical hospitalization
Title
Estimated cost of stay
Description
Estimated cost of stay
Time Frame
During the 5 days of post-surgical hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme PANIEGO, IADE
Phone
0664439476
Ext
+33
Email
j-paniego@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marc MOURAD, MD
Email
m-mourad@chu-montpellier.fr
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme PANIEGO
Phone
0664439476
Ext
+33
Email
j-paniego@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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