Appropriate timing for the removal of urinary catheters in gastrointestinal surgery with epidural anesthesia: A randomized controlled trial

doi:10.21203/rs.3.rs-4682546/v1

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Appropriate timing for the removal of urinary catheters in gastrointestinal surgery with epidural anesthesia: A randomized controlled trial

https://doi.org/10.21203/rs.3.rs-4682546/v1

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published 30 Aug, 2024

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Purpose: The purpose of this randomized controlled trial was to evaluate whether early urinary catheter removal is feasible during epidural anesthesia during gastrointestinal surgery in male patients at high risk for urinary retention.

Methods: Male patients who underwent radical surgery for gastric or colon cancer were enrolled in this randomized controlled trial. Patients were randomized 1:1 into 2 groups: the early group, in which the urinary catheter was removed before removal of the epidural catheter on the second or third postoperative day, and the late group, in which the urinary catheter was removed after removal of the epidural catheter. The randomization adjustment factors were age (≥ 65 or < 65 years) and operative site (gastric or colon). The primary endpoint was urinary retention. The secondary endpoints were the incidence of urinary tract infection and length of postoperative hospital stay.

Results: Seventy-three patients were enrolled between March 2020 and February 2024 and assigned to the Early (n=37) and Late (n=36) groups. Four patients withdrew their consent after randomization. The intention-to-treat analysis showed that urinary retention occurred in 4 patients (11.1%) in the early group and 1 patient (3.0%) in the late group (P = 0.20). Urinary tract infection occurred in 1 patient (3.0%) in the late group. The median postoperative hospital stay was 9 days in both groups.

Conclusion: Early urinary catheter removal in male patients undergoing gastrointestinal surgery with epidural anesthesia could increase urinary retention within the expected acceptable range.

Trial registration number:UMIN000040468

Date of registration: May 21, 2020

Urinary retention

Epidural anesthesia

Gastrointestinal surgery

Randomized controlled trial

The insertion of urinary catheters into patients during the intraoperative and postoperative periods to monitor perioperative hemodynamics has become a common practice. The Enhanced Recovery After Surgery protocol recommends the removal of urinary catheters as early as possible to facilitate rehabilitation and prevent urinary tract infection (UTI) [1, 2]. One concern is that early removal of a urinary catheter during gastrointestinal surgery with epidural anesthesia may result in postoperative urinary retention (POUR) [2–5]. Epidural anesthesia is an important tool for reducing wound pain and facilitating postoperative recovery, and there is a trade-off between the use of epidural anesthesia and early urinary catheter removal.

The optimal timing of postoperative urinary catheter removal in abdominal surgery with epidural anesthesia has not yet been established. The only existing reports were retrospective observational studies [6, 7] or randomized controlled trials [8–12]. These studies included thoracic surgery patients with a relatively low risk of urinary retention. A relevant question in clinical practice is the appropriate timing of urinary catheter removal during epidural anesthesia in abdominal surgery in male patients at high risk for urinary retention [3, 5]. However, evidence regarding this point is currently insufficient.

We conducted a randomized controlled trial in male patients to evaluate whether early urinary catheter removal is feasible during epidural anesthesia. The results of this study may help gastrointestinal surgeons determine the appropriate timing for urinary catheter removal.

Study design

This was a prospective, randomized controlled trial. The study was conducted at a single facility of Southern-Tohoku General Hospital, and the research period was from March 2020 to February 2024. The study was conducted in accordance with the Declaration of Helsinki and relevant local laws and regulations, and was approved by the Institutional Review Board of Southern-Tohoku General Hospital. Written informed consent was obtained from all participating patients (study registration: UMIN000040468; https://www.umin.ac.jp/ctr/index-j.htm).

Participants

Patient enrollment was determined by assessing the eligibility criteria based on the patient's condition on postoperative day 1. The eligibility criteria for enrollment in this study were as follows: 1) male patient of ≥ 18 years of age who underwent radical surgery for gastric or colon cancer, 2) use of an implanted epidural anesthesia catheter and urinary catheter, and 3) provision of consent within 48 h after surgery. The exclusion criteria were as follows: 1) rectal cancer (lower margin of tumor is Ra or Rb), 2) dialysis, 3) patients with preoperative urinary retention who were undergoing urinary drainage or urinary catheterization, 4) total cystectomy or lower urinary tract surgery, 5) patients who required indwelling urinary catheters to measure urine output, and 6) patients whose attending physician determined that epidural anesthesia was completely ineffective.

Randomization and blinding

After obtaining consent from the patient, the physician contacted the data center of the Japanese Society of Clinical Research by telephone and registered the patient in the trial. Randomization was performed using computer-generated random numbers after the person in charge confirmed eligibility at the data center. Patients were assigned 1:1 to the early group, in which the urinary catheter was removed on postoperative day 2 or 3, before removing the epidural anesthesia catheter, and the late group, in which the urinary catheter was removed at least 2 hours after removal of the epidural anesthesia catheter. The allocation factors were surgical site (gastric or colon) and age (≤ 64 or ≥ 65 years). In this study, patients, physicians, and evaluators of the postoperative courses were informed of the allocation results and were not blinded. On the other hand, the statistical analysts were blinded to the allocation results.

Procedure

Epidural catheters were placed perioperatively in the spine from the T7 thoracic level to the L1 lumbar level. The height of the epidural anesthetic puncture was determined by an anesthesiologist. The drugs and concentrations used were 200 mL of 0.2% ropivacaine + 1 mg/ 20 mL of fentanyl (220 mL total), administered at 3–5 mL/hour. Patient-controlled analgesia (PCA) with epidural anesthesia was used postoperatively, depending on the degree of pain. Epidural analgesia was supplemented with intravenous non-opioid and oral analgesics, as needed.

The urinary catheter was removed based on the allocation. After removal of the urinary catheter, residual urine volume was measured by a bladder scan conducted by a trained nurse according to the following criteria: 1) 6 h after removal of the urinary catheter, 2) no urination for more than 6 h, 3) frequent urination with a small volume, or 4) symptoms of lower abdominal distention. The attending physician decided whether it was necessary to perform in-and-out catheterization or reinsert a urinary catheter.

Statistical Considerations

The primary endpoint was the incidence of postoperative urinary retention (POUR). POUR was defined as residual urine volume ≥ 500 mL on bladder scanning or requiring in-and-out catheterization or reinsertion of a urinary catheter. The secondary endpoints included the incidence of urinary tract infection (UTI) and the postoperative length of stay. UTI was defined as fever (> 38°C) and at least one of the following criteria [11]: 1) positive urine culture, pyuria (> 10 WBCs/mm3), 2) physician’s diagnosis, and 3) physician initiated appropriate antimicrobial therapy.

At the time of planning the present study, the timing of urinary catheter removal during epidural catheter insertion was controversial in Japan and was decided by the physician based on an overall assessment of the patient's wishes, infection, urinary retention, and risk of accidental removal. To design a randomized controlled trial of early versus late removal, a structured survey of 20 gastrointestinal surgeons was conducted to determine the clinically acceptable proportion of urinary retention based on the efficacy of early removal. The results showed that the incidence of urinary retention in the late group was 3%, indicating that early removal was acceptable if the incidence of urinary retention in the early group was less than five times (< 15%) that in the late group. Thus, the α level was 0.05 (one-sided), the power was 80%, and we calculated the required sample size to be 69 in each group. Assuming that 10% of patients who met the eligibility criteria might withdraw, the final sample size required was to be 150 patients within 2 years. However, with the rapid spread of minimally invasive surgery (e.g., laparoscopic and robotic surgery) after the start of the registry, the number of patients who did not have epidural anesthesia inserted at the time of surgery increased. The registration period was extended to 3.5 years, but only approximately half of the planned cases were registered. Therefore, the review committee for the safety and efficacy of this study decided not to extend the enrollment period considering the clinical significance of the study results in light of the recent popularity of minimally invasive surgery and the clinical importance of urinary retention.

To prevent publication bias, in this report, we present our descriptive statistics of the primary endpoints for all enrolled patients and report statistical test results and secondary endpoints as reference information. We performed intention-to-treat, per-protocol, and as-treated analyses for the primary and secondary endpoints. Patient characteristics were reported as descriptive statistics, with continuous variables expressed as the median and interquartile range (IQR), and categorical variables were expressed as the number and percentage. Categorical variables were compared using the chi-square test and continuous variables were compared using the Mann–Whitney U test. P values of < 0.05 were considered to indicate statistical significance. All statistical analyses were performed using the STATA software program (version 16.0, STATA Corporation, College Station, TX, USA).

A patient flow diagram is shown in Fig. 1. Seventy-three patients who met the eligibility criteria were randomized. Thirty-seven patients were assigned to the Early group, and 36 patients were assigned to the Late group. Among these, 1 patient in the early group and 3 patients in the late group were excluded from the study because they withdrew their consent after randomization. Finally, we analyzed 36 in the early group and 33 patients in the late groups, respectively. Six patients in the early group could not receive the allocated intervention: early removal of the urinary catheter due to delayed mobilization, and 3 patients had self-removal of the epidural catheter before removal of the urinary catheter.

The patient characteristics are shown in Table 1. There were no statistically significant differences in age, body mass index, surgical site, surgical approach, duration of surgery, intraoperative fluid, level of epidural insertion, comorbidities, or estimated glomerular filtration rate between the groups. Table 2 shows the results of intention-to-treat analyses. POUR occurred in 4 patients (11.1%) in the early group and 1 patient (3.0%) in the late group (P = 0.20). Urinary tract infection occurred in 1 patient (3.0%) in the late group. The median postoperative length of stay was 9 days in both groups. Table 3 presents the results of the per-protocol analysis. The Early group was associated with a higher incidence of POUR (14.8% vs. 0.0%, P = 0.028) in comparison to the late group. There was no significant difference in the incidence of UTI and the postoperative length of stay. Table 4 presents the results of the analysis of the as-treated samples. The early removal of urinary catheters during epidural anesthesia was associated with a higher incidence of POUR (16.7% vs. 0.0%, P = 0.008) in comparison to the late removal of urinary catheters after the removal of epidural catheters.

UTI occurred in 1 patient who was assigned to the late group. UTI occurred on postoperative day 3, and the patient underwent urinary catheter removal before epidural catheter removal on the same day. This patient developed POUR after the removal of the urinary catheter. The residual urine volume at 6 h after the removal of the urinary catheter tended to be higher in the early removal group; however, the difference was not statistically significant.

The incidence of urinary retention, the primary outcome, was similar in both the Early and Late groups to the assumption (3% in the late group and 15% in the early group) made before the study began. The results of this study show that the increase in urinary retention due to early urinary catheter removal was within the acceptable range. The secondary outcomes of urinary tract infection and postoperative hospital stay did not differ between the 2 groups.

Based on the results of this study, it seems certain that the incidence of residual urine and urinary retention increases with early urinary catheter removal. A meta-analysis of previous randomized control trials has reported that the incidence of POUR was 9.1% in the early group and 2.7% in the late group [8–12]. Considering that these trials included female and thoracic surgery patients with a relatively low risk of urinary retention, our results for the incidence of POUR in male patients with gastrointestinal surgery (11.1% in the early group and 3.0% in the late group) are biologically plausible. Epidural analgesia increases the risk of POUR by blocking the transmission of afferent and efferent nervous impulses from and to the bladder [3]. The increase in urinary retention was within the expected range in terms of the incidence of urinary retention. In all cases where urinary retention occurred, it could be treated with relatively minimally invasive procedures, such as in-and-out catheterization or reinsertion of a urinary catheter. Therefore, in our opinion, early removal of urinary catheters is feasible, considering the potential benefits of early removal, such as the reduction of distress of the catheter, facilitation of postoperative mobilization, and reduction of the risk of UTI [1, 2, 13–15]. However, there were 6 patients (16.7%) in the early removal group who could not be removed early as allocated due to delayed mobilization. In cases in which early removal was difficult because of delayed mobilization or in cases with a higher risk of urinary retention (e.g., pelvic surgery for rectal cancer), which were excluded from this study, it may be necessary to delay the removal of the urinary catheter.

The expected benefits of early urinary catheter removal are a reduction in the risk of UTI and shortened postoperative length of stay due to facilitating mobilization [1, 2]; however, these benefits were not evident in the results of this study. This might be because these outcomes were not the primary outcomes and because the sample sizes were relatively small. However, removing urinary catheters as early as possible may reduce patient distress and facilitate mobilization.

The present study was associated with several limitations. First, we were unable to achieve the planned sample size in this study and thus could not draw definitive conclusions from our results. However, by reporting the incidence of urinary retention—the primary endpoint observed in this study—as a descriptive statistic, we showed that the increase in urinary retention due to the early removal of the urinary catheter was within the expected acceptable range. Second, the trained nurses who measured the residual urine volume and the attending physician who decided whether to perform in-and-out catheterization or reinsert a urinary catheter were not blinded, which may have led to bias. However, it would have been difficult in clinical practice to blind trained nurses measuring residual urine volume or the attending physician to determine whether a urinary catheter was inserted. Third, outcomes, such as patient distress and quality of life, should have been measured in terms of the potential benefit of early catheter removal.

The early removal of urinary catheters in male patients undergoing gastrointestinal surgery with epidural anesthesia could increase urinary retention within the expected acceptable range. The early removal of urinary catheters may be feasible in order to reduce patient distress and facilitate mobilization.

Conflict of Interest:

The authors declare that they have no conflict of interest.

Funding

There was no financial support for this research

Author Contribution

All authors contributed significantly, met the authorship criteria, and approved this version of the manuscript for publication. T.M., M.H., and H.K. contributed to the study conception and design, acquisition of data, analysis and interpretation of data, and drafting of the manuscript. R.Y., S.T., S.H., E.N., and Y.T. conceptualized and designed the study. H.K. and R.M. performed statistical analyses. All authors contributed to the acquisition of data and critical revision of the manuscript.

Data Availability

The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request.

Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M et al (2019) Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(®)) Society Recommendations: 2018. World J Surg 43(3):659–695. https://doi.org/10.1007/s00268-018-4844-y
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Table .1 Patient characteristics
	Group
	Early (n = 36)		Late (n = 33)		P-value
Age, years	70.4	(10.8)	70.2	(10.9)	0.96
Body mass index, kg/m²	23.1	(3.2)	23.4	(3.8)	0.74
Surgical site					0.98
Gastric surgery	23	(63.9%)	21	(63.6%)
Colon surgery	13	(36.1%)	12	(36.4%)
Surgical approach					0.49
Open	9	(25.0%)	6	(18.2%)
Laparoscopic	27	(75.0%)	27	(81.8%)
Duration of surgery, min	265.4	(76.7)	244	(54.3)	0.19
Intraoperative fluid, mL/kg per h	7.8	(2.6)	7.9	(3.1)	0.85
Level of epidural insertion					0.75
Th 7-8	4	(11.1%)	1	(3.0%)
Th 8-9	11	(30.6%)	11	(33.3%)
Th 9-10	7	(19.4%)	8	(24.2%)
Th 10-11	9	(25.0%)	6	(18.2%)
Th 11-12	3	(8.3%)	4	(12.1%)
Th 12-L1	2	(5.6%)	3	(9.1%)
Comorbidity
Diabetes	6	(16.7%)	10	(30.3%)	0.18
Neurological disease	3	(8.3%)	4	(12.1%)	0.60
Benign prostatic hyperplasia	6	(16.7%)	6	(18.2%)	0.87
eGFR	71.1	(15.4)	69.2	(16.3)	0.62
Data are presented as n (%) or the mean (standard deviation).
GFR, glomerular filtration rate.

Table 2 Intention-to-treat analysis
	Group
Outcomes	Early (n = 36)	Late (n = 33)	P-value
Urinary retention	4 (11.1%)	1 (3.0%)	0.20
Bladder scan 6h after urinary catheter removed	91.2 (19.6)	64.5 (13.7)	0.28
Urinary tract infection	0 (0.0%)	1 (3.0%)	0.29
Postoperative length of stay, days	9 (8-11.5)	9 (8-10)	0.32
Data are presented as n (%), the mean (standard deviation) or the median (interquartile range).

Table 3 Per-protocol analysis
	Group
Outcomes	Early (n = 27)	Late (n = 30)	P-value
Urinary retention	4 (14.8%)	0 (0.0%)	0.029
Bladder scan 6 h after urinary catheter removed	96.2 (23.5)	64.5 (13.7)	0.24
Urinary tract infection	0 (0.0%)	0 (0.0%)	N/A
Postoperative length of stay, days	9 (8-11)	9 (8-10)	0.85
Data are presented as n (%), the mean (standard deviation) or the median (interquartile range).
N/A, not applicable.

Table 4. As-treated analysis
	Group
Outcomes	Early (n = 30)	Late (n = 39)	P-value
Urinary retention	5 (16.7%)	0 (0.0%)	0.008
Bladder scan 6 h after urinary catheter removed	96.2 (23.5)	65.2 (11.8)	0.21
Urinary tract infection	1 (3.3%)	0 (0.0%)	0.25
Postoperative length of stay, days	9 (8-11)	9 (8-10)	0.68
Data are presented as n (%), the mean (standard deviation) or the median (interquartile range).

No competing interests reported.

Download PDF

Journal Publication

published 30 Aug, 2024

Read the published version in Langenbeck's Archives of Surgery →

Editorial decision: Revision requested
16 Aug, 2024
Reviews received at journal
12 Aug, 2024
Reviewers agreed at journal
05 Aug, 2024
Reviewers invited by journal
08 Jul, 2024
Editor assigned by journal
07 Jul, 2024
Submission checks completed at journal
05 Jul, 2024
First submitted to journal
03 Jul, 2024

You are reading this latest preprint version

Appropriate timing for the removal of urinary catheters in gastrointestinal surgery with epidural anesthesia: A randomized controlled trial

Status:

Journal Publication

Version 1

Abstract

Figures

Introduction

Materials and Methods

Study design

Participants

Randomization and blinding

Procedure

Statistical Considerations

Results

Discussion

Conclusion

Declarations

Conflict of Interest:

Funding

Author Contribution

Data Availability

References

Tables

Additional Declarations

Status:

Journal Publication

Version 1