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Bladder catheter removal 24 hours after surgery

Removal of the bladder catheter after the surgical intervention

Remove urinary catheter after surgery

Xavier Serra-Aracil, MD,PhD

Xavier Serra-Aracil, MD

Xavier Serra-Aracil, MD, PhD

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.

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.

A multicenter prospective, controlled, randomized, non-inferiority study on the management of the bladder catheter in scheduled laparoscopic colon surgery

Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.

Prospective, Controlled, Randomized Multicentric Study of Non-inferiority on the Management of the Vesical Catheter in Colon Surgery. CR-Vesical Cath Study Group

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

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.

hospital stay less than usual in this surgery

According to the Clavien-Dindo classification

Corporacion Parc Tauli

Principal Investigator, Head Colorectal Unit, Clinical Professor

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.

Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).

Flexible cystoscopy

Urinary cytology will be collected through a Ch14 urinary catheter after the cystoscopy

Urinary catheter

Ilaria Lucca, MD

François Crettenand, MD

Urine cytology can be collected with spontaneous urine or by washing the bladder. It is commonly accepted among urologist that instrumental bladder washing is the method of choice. There are, however, no solid recommendations regarding the method to collect the urine for bladder wash cytology during cystoscopy. There are mainly two possibilities: 1) the use of an intermittent bladder catheter after the removal of the cystoscope or 2) bladder lavage through working channel of the flexible cystoscope itself. The first choice may increase the number of collected cells because of the larger caliber of the catheter compared to the working channel and thus the better efficacy of bladder wash. However, this method is certainly more invasive and possibly more expensive. To the best of our knowledge and according to available literature, none of both collection method can be defined as gold standard. The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient. If our study confirms the non-inferiority of "direct" collection through the cystoscope, this will allow the establishment of recommendations in this sense in order to simplify the procedure and reduce as much as possible the manipulations within the urogenital tract.

The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient.

Group A: Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.

Group B: Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).

Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?

Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? A Prospective Randomized Study

Number of urothelial cells, number of inflammatory cells, presence of necrosis or blood will be used to assess this outcome measure

Sensitivity ans specificity percentage will be calculated based on the results of both urinary cytology and cystoscopy

The Faces Pain Scale will be used for each patient after the cytology to assess his satisfaction/pain (0= no pain and 10=the worst pain possible)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.	NCT04070898	Colon Cancer	Remove urinary ...	18 Years - 100 Years	Corporacion Parc Tauli
Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?	NCT05643807	Bladder Cancer	Flexible cystos... Urinary cathete...	18 Years -	Centre Hospitalier Universitaire Vaudois

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