Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.
Primary Purpose
Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Remove urinary catheter after surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring Laparoscopic colectomy, urinary catheter, acute urinary retention
Eligibility Criteria
Inclusion Criteria:
- Any patient who understands, agrees to participate and signs the informed consent
- older than 18 years-old
- electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened
- duration of the surgical act less than 180 minutes
- Prior anesthetic assessment of ASA I-III
- International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker).
Exclusion Criteria:
- - Open surgery or conversion to open surgery
- Performing periodic anesthesia or being ASA IV
- Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months);
- Moderate-severe prostate clinic (IPSS> 19)
- Presence of positive urine culture in men in preoperative tests
- Urinary infection clinic in women with positive urine culture
- Previous history of acute urine retention
- be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization.
- men who underwent prostate surgery
- patients with a history of treatment for urological tumor - patients with a history of urethral stricture, enterovesical fistula or previous pelvic surgery.
- urinary incontinence or neurogenic bladder
- chronic renal failure (CRF) with creatinine levels greater than 2 (including terminal CRI stage or dialysis)
- emergency surgery pregnant
- have received pelvic radiotherapy
- Administration of serum during the operative time> 2,000ml.
Sites / Locations
- Hospital Universitario Parc Tauli de SabadellRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
experimental group
Arm Description
Bladder catheter removal 24 hours after surgery
Removal of the bladder catheter after the surgical intervention
Outcomes
Primary Outcome Measures
Development of acute urine retention after removal of the bladder catheter after colon surgery.
Acute urine retention is defined as
the inability to spontaneous urination at 8 hours after the removal of the bladder catheter
obtaining after urinary catheterization of more than 400 cc of urine or the need for repeated probing due to the impossibility of spontaneous urination
Secondary Outcome Measures
Change incidence of urinary tract infections
Urine culture is more than 10,000 colonies per ml in men or 100,000 colonies per ml in women produced by 1 or 2 microorganisms.
Change of hospital stay
hospital stay less than usual in this surgery
Morbidity changes
According to the Clavien-Dindo classification
Full Information
NCT ID
NCT04070898
First Posted
August 23, 2019
Last Updated
November 15, 2021
Sponsor
Corporacion Parc Tauli
1. Study Identification
Unique Protocol Identification Number
NCT04070898
Brief Title
Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.
Official Title
Prospective, Controlled, Randomized Multicentric Study of Non-inferiority on the Management of the Vesical Catheter in Colon Surgery. CR-Vesical Cath Study Group
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
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
INTRODUCTION: Recommendations for peroperative bladder catheterization remain a controversial issue since it is a procedure that is not without complications. Most of the current suggestions derive from open surgery data that have been extrapolated to Enhanced Recovery After Surgery (ERAS) or Fast-Track programs ranging between 24-48 hours.
The objective of the present study is to find the perfect balance with a better degree of evidence than the current one between the reduction of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery.
Methods: Multicenter, prospective, controlled, randomized non-inferiority study on the management of the bladder catheter in patients undergoing scheduled laparoscopic colon surgery, randomized in two study groups: experimental group (removal of the bladder catheter after surgery ) and control group (removal of the catheter at 24 hours) after the surgical intervention.
The main objective of the present study is to reduce the permanence of the bladder catheter trying to find the balance of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter.
Detailed Description
INTRODUCTION: The usual recommendations for a peroperative bladder catheter vary from surgical reasons to the control of hemodynamics or personal preferences, so since it is not a procedure free of complications, it requires an evidence-based approach.
For hospitalized patients, the optimal duration of bladder catheterization remains controversial. For colorectal surgery, most authors traditionally suggested with limited evidence, based mainly on open surgery data, 5 days with a range of 3 to 10 days, which meant a significant increase in hospital stays associated with an increase of the risk of complications (42-60% of urinary infections).
With the introduction of the Enhanced Recovery After Surgery (ERAS) or Fast-Track programs of minimally invasive surgery it has been shown that old concepts adopted by the inertia of the custom were wrong and therefore the recommended duration of bladder catheterization has been shortened with the aim of reducing the incidence of urinary tract infections without significantly increasing acute urinary retention.
Currently, European international guidelines recommend that bladder catheterization may be limited to a period of 24-48 hours after scheduled colon and rectal interventions, except for resections of the middle and lower rectum (with extensive perineal and rectal dissection) that require the permanence of the bladder catheter for a longer period according to the clinical indications.
The clinical guidelines of the ASCRS (American Society of Colon and Rectal Surgeons) and the SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) are even more restrictive in the use of bladder catheterization in elective colon or upper rectum surgery, recommending its withdrawal within 24 hours after it as they consider that at 48 hours the risk of postoperative urinary tract infection has doubled.
HYPOTHESES AND OBJECTIVES Hypothesis: Although the ERAS guidelines recommend the removal of the bladder catheter at 24 hours or 2-3 days, we believe that it can be removed earlier at the end of surgery without detriment to the increase in acute retention of urine and with the benefit of earlier mobilization and decreased morbidity related to the bladder catheter (urine infection).
The main objective of the study is the assessment of the degree of acute retention of urine after removal of the bladder catheter in colon surgery in the two study groups, control (24 h) and in the experimental group (once the surgical intervention ends ).
As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter. Urine culture samples will be collected if the patient presents a clinic suggestive of urinary tract infection: dysuria, urinary frequency, urgency, suprapubic pain, hematuria or testicular pain.
METHODS / DESIGN Study design This protocol has been designed following the standards of the SPIRIT statement and is a prospective, multicentre, controlled, randomized, non-inferiority study on the management of the bladder catheter in scheduled laparoscopic colon surgery
Inclusion criteria Any patient who understands, agrees to participate and signs the informed consent, that is over 18 years old, operated electively and programmed by laparoscopic colon and upper rectum in which the peritoneal reflection has not been opened, will be included in the study. with a duration of the surgical act less than 180 minutes. The previous anesthetic assessment will be of an ASA I-III and should have an international prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker).
Exclusion criteria Open surgery or conversion to open surgery; performing periodic anesthesia or being ASA IV; preoperative diagnosis of urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months); moderate-severe prostate clinic (IPSS> 19); in men, the presence of positive urine culture in preoperative tests; in women, the urinary infection clinic and the positive urine culture. The previous history of acute urine retention will also be grounds for exclusion from the study; be a carrier of a permanent bladder catheter or ureteral catheter and intermittent self-catheterization. Men who have undergone prostatic deobstructive surgery (Holep, RTUp, Millin or prostatic vaporization) will not be included; patients with a history of treatment for urological tumor (prostate cancer, bladder tumor, ureteral or renal tumor); or have a history of urethral stricture, enterovesical fistula or previous pelvic surgery. Other reasons for exclusion will be urinary incontinence or neurogenic bladder; chronic renal failure (CRF) with creatinine levels greater than 2 (including terminal CRI stage or dialysis); emergency surgery, pregnant women, having received pelvic radiotherapy or the administration of suerotherapy during the operative time> 2,000ml.
Study withdrawal criteria The difficulty / impossibility of intraoperative catheterization, urethral bleeding / hematuria after traumatic catheterization or the need for suprapubic cystostomy placement; the patient who is under active antibiotic treatment due to urinary tract infection at the time of surgery; the need for intraoperative ureteral catheter placement; the need for 24-hour diuresis monitoring by bladder catheterization, the combination with other surgeries (hysterectomy, prostatectomy, etc.), Clavien post-surgical complications> 2 (need to take a probe longer than expected); intraoperative urinary tract injury or the need for peridural anesthesia in the immediate postoperative period.
The preoperative evaluation in men will include an IPSS questionnaire and a urine culture as its positivity will mean exclusion from the study. It will also be evaluated if you take medication for BPH. In women, a urine culture will be performed in case of presenting a urinary infection clinic
Recruitment and scope of the study Patients will be recruited from colorectal surgery units of hospitals participating in the study following the same criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Laparoscopic colectomy, urinary catheter, acute urinary retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicenter prospective, controlled, randomized, non-inferiority study on the management of the bladder catheter in scheduled laparoscopic colon surgery
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Bladder catheter removal 24 hours after surgery
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Removal of the bladder catheter after the surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Remove urinary catheter after surgery
Intervention Description
Remove bladder catheter after surgery
Primary Outcome Measure Information:
Title
Development of acute urine retention after removal of the bladder catheter after colon surgery.
Description
Acute urine retention is defined as
the inability to spontaneous urination at 8 hours after the removal of the bladder catheter
obtaining after urinary catheterization of more than 400 cc of urine or the need for repeated probing due to the impossibility of spontaneous urination
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Change incidence of urinary tract infections
Description
Urine culture is more than 10,000 colonies per ml in men or 100,000 colonies per ml in women produced by 1 or 2 microorganisms.
Time Frame
30 days
Title
Change of hospital stay
Description
hospital stay less than usual in this surgery
Time Frame
30 days
Title
Morbidity changes
Description
According to the Clavien-Dindo classification
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient who understands, agrees to participate and signs the informed consent
older than 18 years-old
electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened
duration of the surgical act less than 180 minutes
Prior anesthetic assessment of ASA I-III
International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker).
Exclusion Criteria:
- Open surgery or conversion to open surgery
Performing periodic anesthesia or being ASA IV
Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months);
Moderate-severe prostate clinic (IPSS> 19)
Presence of positive urine culture in men in preoperative tests
Urinary infection clinic in women with positive urine culture
Previous history of acute urine retention
be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization.
men who underwent prostate surgery
patients with a history of treatment for urological tumor - patients with a history of urethral stricture, enterovesical fistula or previous pelvic surgery.
urinary incontinence or neurogenic bladder
chronic renal failure (CRF) with creatinine levels greater than 2 (including terminal CRI stage or dialysis)
emergency surgery pregnant
have received pelvic radiotherapy
Administration of serum during the operative time> 2,000ml.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Serra-Aracil, MD,PhD
Phone
34-93-723-1010
Ext
21490
Email
jserraa@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Serra-Aracil, MD, PhD
Organizational Affiliation
Corporacio Parc Tauli. Parc Tauli University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Parc Tauli de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Serra-Aracil, MD
Phone
34937231010
Ext
21490
Email
jserraa@tauli.cat
First Name & Middle Initial & Last Name & Degree
Xavier Serra-Aracil, MD
12. IPD Sharing Statement
Learn more about this trial
Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.
We'll reach out to this number within 24 hrs