Necessity of routine perioperative peridual catheter placement in laparoscopic colorectal resections: A prospective data analysis

doi:10.21203/rs.3.rs-1891347/v1

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Research Article

Necessity of routine perioperative peridual catheter placement in laparoscopic colorectal resections: A prospective data analysis

https://doi.org/10.21203/rs.3.rs-1891347/v1

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published 25 Aug, 2023

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Purpose:

Whether epidural anesthesia leads to further improvement in the postoperative course of colorectal procedures is under discussion. This study aimed to evaluate the effects of performing minimally invasive colorectal oncological interventions without a peridural catheter (PDK).

Methods:

This prospective data analysis included all patients with minimally invasive oncological colorectal resection who underwent surgery at our clinic between January 2013 and April 2019. Of 385 patients who met the inclusion criteria, 183 (group I; 47.5% of 385) received a PDK and 202 (group II; 52.5% of 385) did not. Relevant target parameters were evaluated and compared between the groups.

Results:

Group I (n = 183; women, 77; men, 106; age 66.8 years) were younger (p = 0.0035), received a urinary catheter more often (99.5% versus [vs.] 28.2% p < 0.001), required longer, more frequent arterenol treatment (1.1 vs. 0.6 days; p < 0.001), and had a longer intermediate care unit stay than group II (2.8 vs. 1.1 days; p < 0.001). Postoperative pain levels were not significantly different between the groups (p = 0.078). Group I showed later mobilization than group II (4 vs. 2 days; p < 0.001). The postoperative day of the first defecation in both groups was not significant (p = 0.236). Postoperative complications such as bleeding (p = 0.396), anastomotic leaks (p = 0.113), and wound infections (p = 0.641) did not differ between the groups. Group I had a significantly longer hospital stay than group II (12.2 vs. 9.4 days; p < 0.001).

Conclusion:

The omission of a PDK in elective minimally invasive colorectal resections can be safely implemented and is accompanied by no relevant disadvantages to the patient.

PDK

fast track

enhanced recovery

minimally invasive colorectal resection

risk-benefit ratio

Colorectal resection is among the most common surgical procedures performed in hospitalized patients. Perioperative management of these patients has changed significantly over the last few decades. For a long time, it was assumed that a traditional treatment regimen with extended periods of fasting, intensive orthograde colon cleansing, intraoperative insertion of drains, and limited mobilization would reduce the rate of postoperative complications, thus ensuring a successful operation [1]. The associated delayed convalescence and resulting long hospital stay were accepted [1]. At the beginning of the 21st century, average hospital stays for a patient in Germany were 10–12 days after minimally invasive colorectal resection and approximately 15–20 days for conventional surgery [2–5]. Despite a lack of scientific evidence, this traditional treatment concept persists in the minds of many surgeons.

Working groups around the Danish visceral surgeon Henrik Kehlet (Hvidovre University, Copenhagen, Denmark) were able to show as early as the mid-1990s that laparoscopic colon resection in combination with an evidence-based adaptation of the perioperative treatment path with epidural anesthesia, early oral nutrition and forced mobilization significantly accelerated patient convalescence, reduced the rate of non-surgical complications, and thereby reduced the average length of hospital stay to a few days [6–8]. These perioperative treatment steps, documented in randomized controlled studies, are referred to as fast-track rehabilitation. Currently, there are numerous synonyms for fast tracking, such as enhanced recovery after surgery (ERAS), optimal track surgery, and multimodal surgery. The aim of these concepts is to speed up the patient’s convalescence by restoring homeostasis early and reducing perioperative stress reactions [6, 9]. The combination of an atraumatic, layer-appropriate surgical technique and the use of a multimodal treatment path have a positive effect on the extent of the surgically induced homeostasis disorder, severity of postoperative organ dysfunction, and duration of the postoperative autoregulatory disorder. The prerequisite for successful rehabilitation is best possible patient compliance, which is why detailed patient information and motivation are essential. Other pillars of the fast-track concept are preoperative risk optimization; reduction of preoperative sobriety; elimination of orthograde intestinal lavage; modern anesthetic management (avoidance of excessive fluid and volume administration); renunciation of drains, probes, and catheters; rapid oral nutrition; and forced mobilization [10–13].

Low pain in the patient is essential for the outstanding importance of early mobilization. The peridual catheter (PDK) system thus became a central aspect of all fast-track or ERAS concepts [14–17]. In addition to its advantages in terms of freedom from pain and mobilization, positive effects on postoperative intestinal paralysis and the occurrence of general postoperative complications [14–17] have been attributed to thoracic epidural anesthesia (thEDA). However, placement of the PDK is an invasive procedure associated with comorbidities, such as hypotension, dural perforation, or bladder emptying disorders [18–20].

The positive effect of thEDA use on the postoperative course in conventional colorectal interventions has been clearly proven in several studies [15, 21]. Nevertheless, the extent to which thEDA also has a positive influence on patients’ postoperative outcome after minimally invasive colorectal surgery is currently under discussion. The present study aimed to investigate the effect of not using a PDK on the postoperative course after oncological minimally invasive colorectal resections.

Ethical approval was waived by the local Ethics Committee of the medical faculty of the university of Rostock on 10^th of January 2019 in view of the retrospective nature of the study and all the procedures being performed were part of the routine care.

Study design and population

This prospective data analysis used an IT-supported StuDoQ database, which was maintained for prospective documentation of all colorectal resections in our clinic [22]. The completeness of the data input was checked by documentation assistants. The patient files were reviewed to record the data to be evaluated. The data of all patients with minimally invasive oncological colorectal resections who underwent surgery at our clinic between January 2013 and April 2019 were evaluated. Patients with intraoperative conversion or a change in the surgical procedure were excluded from the study.

We categorized patients into two groups that differed owing to the introduction of a new standard operating procedure for perioperative management. In group I, the placement of a PDK was standard (183 patients, 47.5%). In group II, non-placement of a PDK was standard (202 patients, 52.5%).

Data collection

To compare both groups, we recorded patient-related data, such as age, sex, American Society of Anesthesiologists score (ASA-score), and comorbidities (Table 8), and disease-specific data, such as placement of a urinary catheter, arterenol treatment, intensive care unit (ICU)/intermediate care unit (IMC) stay, pain score, mobilization, defecation, intra-/postoperative complications, and length of hospital stay (Tables 1, 2, 3).

For the target parameter of urinary catheter, we compared urinary catheter installation (yes/no) between the groups. For arterenol treatment, we recorded the need for administration, duration, and ICU/IMC stay. The following variables were recorded for pain: percentage of pain-free postoperative days the first 5 days after surgery (Fig. 1), percentage of postoperative days with pain scores >3 in the first 5 days after surgery (Fig. 2), percentage of postoperative days with a maximum pain score in the first 5 days after surgery (Fig. 3), and number of postoperative days with maximum pain in the first few 5 days after the operation (maximum postoperative pain). Daily pain control was performed in all patients using the visual pain analog scale.

Pain management

Group I received analgesia via the PDK with 0.2% ropivacaine+0.75 mg/mL of sufentanyl at a continuous flow rate of 8 mL/h and the possibility of a 6-mL bolus administration every 8 hours. Additionally, these patients received a non-opioid analgesic according to the World Health Organization (WHO) stage I.

Group II received a modified transverse abdominis plane (TAP) block intraoperatively through the application of 75 mg of ropivacaine and postoperative pain therapy according to World Health Organization stage III.

Postoperative care and outcomes

All patients received postoperative concomitant medication for constipation and nausea as needed. Regarding mobilization, we recorded the postoperative day on which the patients were mobile in the ward corridor. The postoperative day on which the first bowel movement began was evaluated for target bowel movements. Regarding complications, secondary bleeding requiring revision and/or transfusion, anastomotic leaks, and wound infections were recorded.

Statistical analysis

Scale variables are expressed as count, mean, standard deviation, quartile, extrema (minimum and maximum), and median. The distribution of categorical data is described using absolute and relative frequencies. The normal distribution of data in groups I and II was initially assessed using the Shapiro–Wilk test. If the assumption of a normal distribution was not rejected (p³0.05), a comparison was performed using the t-test. If the assumption of a normal distribution was rejected, the Mann–Whitney-U test was used. If cell frequencies <5 were expected, the chi-square test or Fisher exact test was used to compare the frequency distributions of the categorical variables between the two groups. All tests were two-tailed. The analysis was purely exploratory in nature. Therefore, p-values were interpreted descriptively.

In total, 385 patients with colorectal carcinoma who underwent minimally invasive oncological surgery were analyzed. A PDK was placed in 47.5% of patients in group I (n = 183), and resection was performed without a PDK in 52.5% of patients in group II (n = 202). Overall, 43.1% of patients were female (n = 166), and 56.9% were male (n = 219). The frequency of PDK placement did not differ between the sexes (p = 0.757). The median age of patients with a PDK was 67 years (67 years; minimum 38 years, maximum 89 years), and that of the patients without a PDK was 3 years (70 years; minimum 32 years, maximum, 93 years). The age difference was significant between the groups (Table 1).

In this study, 52.5% of patients had colon carcinoma (n = 202) and 47.5% had rectal carcinoma (n = 183); 39.6% of patients (n = 80) with colon carcinoma and 56.3% of patients (n = 103) with rectal carcinoma underwent PDK placement. Almost all patients in group I (99.5%, 182/183) also received a urinary catheter because PDK placement traditionally went hand in hand with the intraoperative placement of a suprapubic catheter. In group II, a urinary catheter was placed in 28.2% (57/202) of patients (Table 3).

In group I, 52.2% of patients required postoperative arterenol treatment for a mean duration of 1.1 days (Tables 1, 2). Of 202 patients in group II, 11.9% (24 of 202) required postoperative arterenol treatment for a mean duration of 0.6 days. Group I spent an average of 2.8 days in an IMC/ICU, whereas group II spent an average of 1.1 days in an IMC/ICU (p < 0.001) (Tables 1, 2).

Overall, 13% of patients in group I (24/179) were pain-free over the investigation period of 5 days postoperatively compared to < 7% of patients in group II (13/200) (p < 0.001) (Fig. 1; Table 3). In group I, 3% (5/179) had a pain score > 3; in group II, 4% (8/200) had a pain score > 3 (p = 0.070) (Fig. 2; Table 3). Group I patients were mobile later than group II patients (4 versus [vs.] 2 days; p < 0.001).

The lengths of time until the onset of the first bowel movement were 3 days in group I (minimum day 1, maximum day 9) and 2 days in group II (minimum day 1, maximum day 8; p = 0.236) (Table 1). The difference between the groups was not significant.

In group I, 1.3% of patients had rebleeding (1/79); in group II, there was no case of rebleeding (0/122; p = 0.396, Table 3). Anastomotic leaks occurred in approximately 9% of patients (17/183) in group I and 5.1% of patients in group II (10/186; p = 0.113; Table 3). In group I, 7.7% of patients (14/183) had a wound infection, while in group II, 6.4% of patients (13/189) had a wound infection (p = 0.641) (Table 3). The lengths of hospital stay were 12 days in group I and 9 days in group II (p < 0.001; Table 1).

Optimal analgesia plays a major role and is an important prerequisite for patient compliance in the postoperative phase. Insufficient analgesia after visceral surgery leads to a lack of mobilization and prolonged intestinal atony. Efficient and consistent postoperative pain therapy is a basic requirement to achieve rapid recovery within the framework of fast-track rehabilitation. Numerous studies around the turn of the millennium have shown that the additional use of thPDA after open abdominal surgery has a positive effect on postoperative intestinal paralysis and the occurrence of general postoperative complications [14–17].

Popping et al. published a meta-analysis of randomized controlled trials in 2014. They concluded that PDK analgesia during gastrointestinal procedures reduced postoperative bowel paralysis, dampened the stress response, reduced pulmonary and cardiac complications, and improved pain control, but it also increased the risk of hypotension, pruritus, voiding dysfunction, and motor dysfunction [23]. However, some studies have shown conflicting results regarding the benefits of epidural anesthesia [21, 24–26]. Hughes et al. concluded that epidural anesthesia did not improve convalescence or reduce postoperative morbidity after conventional abdominal surgery [25].

In addition to the positive effects, PDK placement is associated with potential complications. The most common complication when placing a thoracic PDK is dural perforation, with an incidence of 0.6–1.2% [18, 19]. “High” subdural and spinal anesthesia as well as incorrect placement of the catheter are further complications or undesired side effects. Up to 33% of the catheters showed caudal advancement, about 65% of the catheters were in the left the medio-dorsal position and were (antero-) lateralizing, and almost all catheters (87%) were curved [27].

In addition, there are associated respiratory complications, such as respiratory depression (0.01–3%) or cardiocirculatory side effects, such as vasodilatation with the resulting hypotension and risk of catecholamine dependence. Neurological complications, such as bladder emptying disorders due to blockage of the parasympathetic nervous system with the need for bladder catheter installation, are also worth mentioning, as they have an incidence of 5–70% [19, 20, 28–30].

In 2014, Halabi et al. published a United States-wide study on the disadvantages of the PDK system that included a large sample of 191,000 patients. This study showed that PDK placement is associated with a significantly longer hospital stay and a 1.8-fold increased risk of urinary tract infections because of the need for urinary catheter placement due to PDK-induced bladder emptying disorders [31]. In our study, almost all patients in group I received a urinary catheter. For us, this was because PDK placement traditionally went hand in hand with the intraoperative placement of a suprapubic catheter to counteract the expected postoperative bladder emptying disorder. In group II, however, only one-fourth of the patients required a urinary catheter.

Of particular importance in practice is hypotension, which almost always occurs in patients under epidural anesthesia without prophylaxis and therapy, with subsequent reduced cerebral oxygen supply [32]. This was confirmed by the present study’s results. Over half of our group I patients required arterenol compared to only a minority of group II patients. Additionally, regarding the duration of arterenol treatment, group I received arterenol for almost twice as long as group II. As a result, group I patients spent 1 day longer in the IMC.

Recent studies have suggested that the current gold standard in the fast-track concept, epidural anesthesia, is overused in minimally invasive colorectal procedures [33–36]. In 2019, Juri published a data analysis of 560 patients (283 with PDK placement and 277 without) from 14 Italian clinics who underwent minimally invasive colorectal resection as part of the Italian ERAS concept. The authors concluded that PDK placement in the context of laparoscopic colorectal surgery shows no advantage in terms of pain control and postoperative outcomes compared to oral analgesic therapy [33]. We were also able to show in our results that the pain days with a pain score > 3 were almost identical between the two groups.

Surprisingly, in group I, 14% of patients reported maximum pain over the entire investigation period of 5 postoperative days. In group II, however, only a small proportion of patients (7%) complained of extreme pain during the study period. Only the number of completely pain-free days was significantly higher in group I than in group II. Thus, no improvement in pain control with PDK placement was achieved in our study.

In 2017, Hannah et al. published a randomized controlled trial that included 87 patients. They were able to show that PDK placement in the context of minimally invasive colorectal interventions did not have a positive effect on pain control, diet, and length of stay; rather, mobilization was delayed by hypotension [34]. This delayed mobilization was also confirmed in our data analysis.

Only a small percentage of group I patients (2.7%) was able to mobilize themselves in the ward corridor on the first postoperative day, but almost half of all group II patients were able to (46.5%). Mobilization on the ward corridor was delayed by 2 days in group I.

In 2013, Khan et al. published the results of a randomized controlled study on the effect of PDK placement on bowel function in laparoscopic colorectal resection. They compared 6 different studies published between 1999 and 2011. In 2 studies, the authors showed a positive influence of PDK placement on bowel regulation (onset of the first bowel movement). In the other 4 studies, the authors concluded that the PDK system had no positive effect on stool regulation [35]. Our study showed that PDK placement did not appear to be beneficial for stool regulation. The time until the onset of the first bowel movement was 1 day later in group I than in group II.

In our study, delayed mobilization combined with a longer IMC stay led to significant prolongation of length of hospital stay in group I patients. Borzellino et al. published a data analysis of 331 patients (168 patients with PDK placement and 163 patients without) from various studies published between 2000 and 2016 in which minimally invasive colorectal resection was performed as part of the ERAS concept. The authors showed that patients with PDK placement had a longer hospital stay but without significant differences in terms of postoperative complications and readmission rates [36].

The median length of stay of 5 days in group I in our study is important. This means that we significantly exceeded the 2–3 days recommended by the fast-track concept for PDK placement. Yet, in our case, this was conventional.

Schwenk published a tabular overview of the perioperative management of colorectal surgery in fast-track rehabilitation [1]. Twenty years after the establishment of the fast-track concept, there has been a strong focus on promising alternatives to thPDA, such as TAP block, continuous infiltration analgesia of the wound, and continuous intravenous lidocaine infusion [37–40]. Although the TAP block, in particular, has equivalent analgesic potency and is less invasive to thPDA, these methods have not been established to date and are still of secondary importance in the context of the fast-track concept [41–43].

In addition to adequate systemic and enteral analgesia, PDK placement is currently an integral part of the multimodal fast-track concept and should be used regularly for conventional colorectal and major visceral surgical interventions, based on the available data. Our study findings indicate that the omission of a PDK in elective minimally invasive colorectal resections can be safely implemented and is accompanied by no relevant disadvantages to the patient. However, in the case of minimally invasive colorectal resections, PDK placement should only be used in exceptional cases, i.e., patients with an individually increased risk of postoperative intestinal paralysis and expected long-term use of systemic opioids. Further studies are needed to determine the most appropriate analgesic regimen based on the fast-track concept after laparoscopic colorectal surgery.

There are no relevant financial or non-financial competing interests to report. The authors declare that they have no conflict of interest

Ethical approval:

Consent to participate:

Consent to participate has been obtained

Consent to publish:

All authors have given consent for publication

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Anja Köhler, Franziska Koch and Mohamad El-Ahmar. Matthias Ristig and Jörg-Peter Ritz have set the target parameters and monitored the analysis. Anja Köhler wrote the manuscript. Franziska Koch, Mohamad El-Ahmar and Jörg-Peter Ritz commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Competing interests:

No competing interests reported

Funding:

No funding was received for conducting tis study

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Table 1 General results of the study (descriptive parameters of the metric variables of interest depending on PDK yes/no as well as the p-value of the group in comparison based on the total collective)


Variable	PDK	n	medium	SDA	min	25 %-perc.	median	75 %-perc.	max	p^*
age [years]	no	202	69.1	11.3	32	61	70	78	93	0.035
	yes	183	66.8	11.0	38	58	67	76	89
post-op discharge	no	202	9.4	7.8	3	5	7	11	72	<0.001
[days]	yes	183	12.2	8.4	6	8	9	13	64
length of time PDK	no
[days]	yes	183	5.1	1.8	1	4	5	5	14
1. bowel movement	no	202	2.6	1.3	1	2	2	3	8	0.236
[days]	yes	182	2.9	1.7	1	2	3	4	9
length of time IMC	no	202	1.1	3.9	0	0	0	1	32	<0.001
[days]	yes	183	2.8	4.3	0	1	1	3	38
length of time Arterenol	no	202	0.6	3.2	0	0	0	0	31	<0.001
[days]	yes	182	1.1	1.7	0	0	1	2	16
time to go	no	202			1	1	2	3	6	<0.001
[days]	yes	183			1	3	4	5	6
max. post-op	no	200	4.2	2.2	0	3	4	5	10	0.078
Pain	yes	179	3.8	2.2	0	2	4	5	9
medium post-op	no	200	2.37	1.53	0.0	1.2	2.2	3.4	6.8	<0.001
Pain	yes	179	1.74	1.39	0.0	0.6	1.6	2.6	6.4
pain > 3	no	200	1.5	1.5	0	0	1	2	5	0.008
[days]	yes	179	1.0	1.3	0	0	1	2	5

max=maximum, min=minimum, perc.=percentile; *p-value of the Mann-Whitney-U test

Table 2 Frequency distributions of the categorical variables of interest separately for PDK yes/no and the p-value of the group comparison based on the total collective

		PDK
		no n=202		yes n=183
Variable	value	n	%*	N	%*	p value**
Gender	male	113	55.9	106	57.9	0.757
Gender	female	89	44.1	77	42.1
IMC	no	180	89.1	101	55.2	<0.001
IMC	yes	22	10.9	82	44.8
Arterenol	missing			1
	no	178	88.1	87	47.8	<0.001
	Yes	24	11.9	95	52.2
time to go [days]	1	94	46.5	5	2.7	<0.001
	2	53	26.2	29	15.8
	3	19	9.4	57	31.1
	4	9	4.5	33	18.0
	5	8	4.0	22	12.0
	6	19	9.4	37	20.2
pain> 3 [days]	missing	2		4
	0	73	36.5	84	46.9	0.065
	1	48	24.0	44	24.6
	2	30	15.0	26	14.5
	3	20	10.0	14	7.8
	4	21	10.5	6	3.4
	5	8	4.0	5	2.8

*The percentages refer to the share of the line variable within PDK yes/no

(Column sum per variable = 100%).

**p-value of Fisher's exact test

Table 3 Frequencies of the categorical variables depending on PDK no/yes

		PDK
		no n=202		yes n=183
variable	value	n	%*	n	%*	p¹⁾
Gender	male	113	55.9	106	57.9	0.695
Gender	female	89	44.1	77	42.1
ASA	1	12	5.9	27	14.8	<0.001²⁾
	2	73	36.1	87	47.5
	3	109	54.0	68	37.2
	4	8	4.0	1	0.5
heart disease	missing	1
	No	175	87.1	160	87.4	0.914
	yes	26	12.9	23	12.6
diabetes mellitus	missing	80		103
	No	92	75.4	63	78.8	0.583
	yes	30	24.6	17	21.3
arterial hypertension	No	70	34.7	72	39.3	0.341
arterial hypertension	yes	132	65.3	111	60.7
post-op. bleeding	missing	80		103
	No	122	100	79	98.8	0.396²⁾
	yes			1	1.3
anastomotic leak	missing	6
	No	186	94.9	166	90.7	0.113
	yes	10	5.1	17	9.3
wound infection	No	189	93.6	169	92.3	0.641
wound infection	yes	13	6.4	14	7.7
bladder catheter	No	145	71.8	1	0.5	<0.001
bladder catheter	Yes	57	28.2	182	99.5
pain = 0 [days]	missing	2		4
	0	61	30.5	30	16.8	<0.001
	1	47	23.5	26	14.5
	2	38	19.0	29	16.2
	3	34	17.0	39	21.8
	4	7	3.5	31	17.3
	5	13	6.5	24	13.4
pain > 3 [days]	missing	2		4
	0	73	36.5	84	46.9	0.070
	1	48	24.0	44	24.6
	2	30	15.0	26	14.5
	3	20	10.0	14	7.8
	4	21	10.5	6	3.4
	5	8	4.0	5	2.8
maxium pain [days]	missing	2		4
	1	119	59.5	118	65.9	0.006
	2	43	21.5	28	15.6
	3	19	9.5	8	4.5
	4	5	2.5
	5	14	7.0	25	14.0

*The percentages refer to the share of the line variable within PDK yes/no

(Column sum per variable = 100%).

1) p-value of the chi-square test, 2) p-value of Fisher's exact test

No competing interests reported.

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published 25 Aug, 2023

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Necessity of routine perioperative peridual catheter placement in laparoscopic colorectal resections: A prospective data analysis

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