The effect of antibiotic therapy before percutaneous nephrolithotomy on the frequency of postoperative complications

doi:10.21203/rs.3.rs-3398034/v1

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The effect of antibiotic therapy before percutaneous nephrolithotomy on the frequency of postoperative complications

https://doi.org/10.21203/rs.3.rs-3398034/v1

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Purpose:

Stone disease is affecting 0.13% of the population in the world, and percutaneous nephrolithotomy (PCNL) could be effective and safe to treat complex or large volumes of nephrolithiasis. PCNL may have considerable risks and complications, such as fever.

Patients and Methods:

We conducted a retrospective clinical study on 708 patients who underwent PCNL in the Razi Hospital. Patients were allocated into two groups; group 1 included 454 patients with at least an antibiotic therapy experience, and group 2 included 254 patients without pre-operative antibiotic therapy.

Results:

241(53.1%) males and 213(46.9%) females were in group 1, and 137(53.9%) males and 116(45.7%) females were in group 2. 82.7% of patients treated with antibiotics had a negative culture. The hospitalization time in patients was 4.00± 1.74 days (group 1) and 2.26 ± 1.5 days (group 2). The fever was seen in 39(11.9%) patients (group 1). Sepsis was seen in only one patient in group 1 (0.3%). There is a significant relationship between total hospitalization (P-value=0.000), hospitalization after operation (P-value=0.000), hypertension (p-value =0.009), ischemic heart disease (p-value =0.050), history of shock wave lithotripsy (p-value =0.003), hydronephrosis (p-value =0.000), age (P-value=0.004), and hemoglobin (P-value=0.000) with antibiotic therapy.

Conclusion:

A few patients who underwent PCNL suffer from fever despite antibiotic therapy. Overall, we found that antibiotic therapy does not play an effective role in reducing post-operative fever.

Percutaneous nephrolithotomy

Antibiotic therapy

Complications

Kidney Stone

Fever

Percutaneous nephrolithotomy (PCNL) is the efficient procedure of removing renal calculi, especially among patients with a large or complex stone burden [1, 2]. Since PCNL's introduction in 1976, the novel operative technique and the endoscopic types of equipment are constantly evolving, increasing the success rates and decreasing complications and morbidity [2, 3]. However, the fever secondary to a urinary tract infection (UTI) post-PCNL is the most common, and the fever (21–39.8% C) occurs in more than one-third of patients [4–6]. Fevers of post-PCNL are transient, but some patients could develop sepsis, which is a serious [7, 8]. The UTI pathogenesis of post-PCNL seems to begin with the release of bacteria from surgical manipulation, with the fragmentation of calculi, and/ or via the nephrostomy tract [9].

Furthermore, the risk of post-PCNL infection is increased with positive pre-operative urinary culture, female sex, operative time, use of a nephrostomy tube, diabetes mellitus (DM), body mass index (BMI), pelvicalyceal system dilatation [10, 11], prior PCNL procedures, and intraoperative factors including average renal pressure sustained during PCNL, operative time, number of tracts and degree of blood loss [9, 10]. Positive renal pelvis urine culture is also considered a significant risk factor for post-PCNL fever [12]. The associations between these factors and the post-PCNL risk of UTIs are largely inconsistent across studies [13]. Some studies showed that consuming a short course of preoperative antibiotics significantly decreases the rate of post-PCNL fever and sepsis [11]. The European Association of Urology (EAU) guidelines advised that PCNL patients who suffer from infection stones, a recent history of UTI, and/or a positive urine culture should take antibiotic therapy before the PCNL, and it should be continued for at least four days postoperatively [14]. It is confirmed that the risk of post-PCNL infectious complications may be reduced after antibiotic therapy [13]. Still, recently, physicians know that antibiotic therapy was unsuccessful in eliminating the risk of infection [15]. The Clavien grading system is also a classification system that provides an objective grading system for complications of PCNL [16]. The current investigation aims to review the role of antibiotic therapy in developing post-operative complications, especially fever and UTI, among PCNL patients.

We conducted a retrospective clinical study on 708 patients who underwent PCNL in the Razi Hospital. The study was approved by the hospital's Ethical Committee (IR.GUMS.REC.1399.081). Seven hundred and eight patients with PCNL were allocated to two groups: group 1, including 454 patients who had at least an antibiotic therapy experience, and group 2, including 254 patients who had no pre-operative antibiotic therapy. This study treated patients with at least a urinary tract infection with antibiotics two weeks before PCNL. Also, patients who had a negative urine culture -two weeks before PCNL- did not receive any antibiotics. Patients with pre-operative fever, under 16 years old, and patients with nephrostomy tubes were excluded from the study.

Before the operation, the routine physical examination and routine investigations of PCNL patients were done by a urology resident. Pre-operative and during-operation information of PCNL patients, including age, sex, weight, BMI, hemoglobin, creatinine, glomerular filtration rate (GFR), history of stone surgery, degree of hydronephrosis, pre-operative antibiotic therapy, number, location, size of the stones, types staghorn stones, surgery time, residual fragments, hospitalization, underline disease were recorded. The postoperative complications of PCNL patients, such as a history of Extracorporeal shock wave lithotripsy (ESWL), history of renal transplant, history of Ureteroscopy (URS), ischemic heart disease (IHD), Hypertension (HTN), and DM, also were recorded. Next, ultrasound examinations of the kidney and bladder of patients were done. The kidneys, ureters, bladder x-ray (KUB), and intravenous pyelogram (IVP) were done. In some patients with unclear urinary tract anatomy, computed tomography (CT) with contrast enhancement was performed. Regardless of patients' positive or negative urine culture, a single dose of prophylactic antibiotics was prescribed at the beginning of anesthesia, according to standard treatment protocol. Postoperative hemoglobin, creatinine, Glomerular filtration rate (GFR), and hospitalization time after operation were collected.

In this study, a fever less than 36°C or greater than 38°C, a heart rate greater than 100 beats/min, a respiratory rate greater than 20 breaths/min or PaCO₂ lower than 32 mm Hg, and white blood cell (WBC) count greater than 12×10⁹/L or less than 4 × 10⁹/L was defined as fever or sepsis [17].

In this study, all patients performed a mid-urine exam at admission. Any more than 100,000 bacteria growth was regarded as a positive urine culture (infected urine). After data cleaning, the data were entered into a Microsoft Excel spreadsheet and then transported into SPSS (IBM, IL, USA) for statistical analysis. Descriptive statistics (mean, standard deviation, minimum, maximum, numbers, and percentage) were calculated for variables. Probability measures were used; the analytical statistics were done to find the relations between variables with p-value < 0.05 considered significant.

In this study, 241 males (53.1%) and 213 females (46.9%) were included in group 1, and 137 males and 116 females were included in group 2 (Table 1). The mean age of patients in group 1 and group 2 were 49.11±12.51 years and 51.65±12.23 years, respectively (Table 1). The BMI of patients in groups 1 and 2 also were 27.73±4.94 and 28.33±4.65, which overweight was seen in 174(38.3) patients in group 1, and 111(43.7) patients in group 2 (Table 1). The mean of serum hemoglobin and creatinine (pre-operative and post-operative) in the two groups has been shown in Table 1. The history of the stone surgery of patients is shown in Table 1. As we show in Table 1, pelvic stones were diagnosed in 66(14.8%) patients (group 1) and 40(16.4%) patients (group 2). In this study, 20(33.9%) patients in group 1 also had partial staghorn. Findings showed that the duration of surgery in group 1 and group 2 were 45.48 ± 18.44 minutes and 46.15 ± 18.01 minutes, respectively (Table 1). This study showed that 82.7% of patients treated with antibiotics had a negative culture at admission. However, only 17.3% of patients treated with antibiotics had a positive urinary culture at admission (Table 1). The hospitalization time in patients under PCNL was 4.00± 1.74 days (group 1) and 2.26 ± 1.5 days (group 2). We found that 34(7.6%) patients in group 1 and 15(6%) patients in group 2 have at least a residual fragment of more than 4 mm (Table 1). One hundred and seventy-seven (39%) patients in groups 1 and 100(39.4%) patients in groups 2 had a history of ESWL. Also, 147(32.4%) and 84(33.1%) patients in groups 1 and 2 suffered from HTN. DM was observed in 77(17%) and 47(18.5%) of patients in groups 1 and 2, respectively (Table 1). One hundred and twenty-three (27.1%) patients in group 1 and 12.6% in group 2 showed postoperative complications. Interestingly, the fever above 38 °C was seen in 39(11.9%) patients (group 1). Also, sepsis was seen in only one patient in group 1 (0.3%) (Table 1). The current study showed that there is a significant relationship between total hospitalization (P-value=0.000) and hospitalization after operation (P-value=0.000) with antibiotic therapy (Table 2). In terms of the underlying disease, a significant statistical relation was seen between patients with HTN (p-value =0.009), IHD (p-value =0.050), history of ESWL (p-value =0.003), and antibiotic therapy (Table 2). Also, there was a significant statistical relationship in the postoperative complications between hydronephrosis and antibiotic therapy (p-value =0.000) (Table 2). Findings show that there was a significant statistical relation between the means of age (P-value=0.004) and hemoglobin (P-value=0.000) with antibiotic therapy (Table 3) (figure1).

Post-operative complications are mainly one of the risk factors in patients undergoing PCNL surgery [18]. These complications, such as fever, sepsis, extravasation, and transfusion, could be significantly associated with mortality and impose a high cost on the patient [19]. Of 708 patients, 454 were allocated an antibiotic therapy experience (Group 1), and 254 had no pre-operative antibiotic therapy after PCNL (Group 2). In the current study, more than 50% of patients were males (Table 1) and were in the overweight category of the BMI group (Table 1). Reports have shown that in 21–39.8% of patients, fever secondary to a UTI is one of the most common outcomes of PCNL [11]. Previously, antibiotic therapy seemed an excellent procedure to prevent postoperative complications, especially fever and sepsis [11]. However, in some conditions, patients may have antibiotic therapy experience without a UTI or with a negative urine culture [11]. The current study shows that 11.2% of the patients who had antibiotic therapy experienced a post-operative fever.

Interestingly, only 3.9% of patients without antibiotic therapy experienced a post-operative fever. The prevalence of postoperative fever was higher in patients who received antibiotic therapy than in patients who did not before surgery. Also, sepsis was seen in only one case (0.3%) of patients who had previously received antibiotic therapy. In total, 27.1% of patients who received antibiotic therapy showed at least one of the postoperative complications, such as fever, extravasation, transfusion, and sepsis. In comparison, only 12.6% of patients who did not have antibiotic therapy showed post-operative complications. These results indicate that antibiotic therapy before surgery may play a lesser role in complications after surgery, such as fever or sepsis.

There may be some possible limitations in this study. In the current research, some people may have refused to provide accurate answers and gave unrealistic answers. This research has been conducted cross-sectionally over 10 years. For this reason, it is challenging to conclude causality. This research was conducted on patients with kidney stones in Razi Hospital, Rasht, who underwent PCNL, and therefore, it cannot be generalized to the entire population. We know most early postoperative fever is caused by the inflammatory stimulus of tissue damage and exposure to physiologic fever during surgery. Starting on postoperative day 4, infections related to the surgical procedure are more common. We do not always assume that fever is due to infection. In fact, for many conditions of patients, the presence of fever may be variable. We excluded patients with immunocompromised, including those receiving glucocorticoids, cancer chemotherapy, and post-transplant immunosuppression. Also, patients who were older, cachectic, frail, or had chronic renal failure may had a blunted fever response to infection. However, we do not assume that fever is always due to infection. In fact, for many conditions of patients, the presence of fever may be variable.

The major hypothesis of this study was whether antibiotic therapy could reduce complications such as post-operative fever and sepsis in patients who underwent PCNL. The emergence of infection in our populations is serious. It could lead to increased complications, increased cost of treatment, and increased length of hospital stay of patients. It is suggested that in the future, the difficulties of post-operative PCNL in patients who had received antibiotic therapy be investigated and compared in a randomized, double-blind clinical trial.

We firmly believe that indiscriminate antibiotic prescription by a surgeon could be a trigger to the appearance of antibiotic-resistant bacteria. The emergence of new generations of antibiotic-resistant bacteria in our populations is severe. It could lead to increased complications, increased cost of treatment, and increased length of hospital stay of patients. If we look realistically, antibiotic therapy and prophylaxis cannot prevent post-operative complications in some patients. The surgeon's experience can explain this failure, the emergence of antibiotic-resistant bacteria, and indiscriminate antibiotic prescription pre-operative PCNL.

Ethical approval

This study was conducted according to the guidelines laid down in the Declaration of Helsinki, and all procedures involving human participants were approved by the Ethics Committee of Guilan University of Medical Sciences (IR.GUMS.REC.1399.081).

Informed consent

Response: This study was a cross-sectional retrospective study. We just extracted data of patients who underwent PCNL in the past from their documents. However, informed consent was obtained from all participants. We excluded participants under 16 years old from the study. All personal information of the patients remained confidential. And also, the principles of trusteeship were fully respected by the researchers.

Consent for publication

Not applicable

Availability of data and material

The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

The author(s) received no specific funding for this work.

Authors' contributions

Conceptualization: S.F, A.J

Data curation: A.J, S.F

Formal analysis: A.J, A.B, S.F

Funding acquisition: A.J, S.F

Investigation: A.J

Methodology: A.J, S.F, M.B.S

Project administration: A.J, S.F

Software: A.J, S.F

Validation: S.F

Visualization: A.J, A.B

Writing – original draft: A.J, S.F, A.B

Writing – review & editing: A.J, S.F, A.B

All authors read and approved the final manuscript.

Acknowledgments

We would like to thank Guilan University of Medical Sciences for its assistance and guidance in this research.

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Table 1- General information of patients before operation (n = 708)

Variable			Antibiotic therapy
			Yes (n=454/ Group 1)	No (n=254/ Group 2)
Sex; Male / Female, n (%)			241/213(53.1/46.9)	137/116(54.2/45.8)
Age; Mean (SD)			49.11(12.51)	51.65(12.23)
Weight (g), Mean (SD)			76.10(14.61)	77.67(13.15)
BMI, Mean (SD)			27.73(4.94)	28.33(4.65)
BMI group, n (%)	Under weight		12(2.8)	7(2.9)
	Normal		120(28.3)	57(23.3)
	Over weight		174(41)	111(45.3)
	Obese		118(27.8)	70(28.6)
Hemoglobin. (g/dL), Mean (SD)	Preoperative		13.08(1.74)	13.84(8.17)
	Postoperative		11.55(1.8)	12.37(1.82)
Creatinine (mg/dl), Mean (SD)	Preoperative		1.23(2.23)	1.1(0.55)
	Postoperative		1.25(3.31)	1.05(0.53)
Glomerular filtration rate (min), Mean (SD)	Preoperative		81.35(30.38)	113.99(38.51)
	Postoperative		83.8(26.56)	86.57(27.63)
History of stone surgery; n(%)			220 (48.8)	127 (50.4)
Number of stones, Mean (SD)			1.69(0.46)	1.74(0.44)
Urine culture before operative		Positive	78(17.3)	32(18.5)
		Negative	376(82.7)	222(81.5)
Stone size (mm), Mean (SD)			33.51(13.69)	32.77(14.08)
Location of stones, n(%)	Upper calyx		26(5.8)	17(7)
	Middle calyx		17(3.8)	10(4.1)
	Lower calyx		60(13.4)	31(12.7)
	Pelvis		66(14.8)	40(16.4)
	Staghorn		19(4.3)	16(6.6)
Staghorn stone; n(%)			39 (9.4)	26 (10.8)
Type of staghorn	Complete		12(20.3)	8(25)
	partial		20(33.9)	13(40.6)
Surgery time (min), Mean (SD)			45.48(18.44)	46.15(18.01)
Total hospitalization (days), Mean (SD)			4.00(1.75)	2.26(1.56)
Hospitalization after operation (days), Mean (SD)			2.83(1.33)	1.75(0.96)
Outcome; n(%)	Stone-free		390(87.2)	227(90.4)
	Residual fragment <4mm		23(5.1)	9(3.6)
	Residual fragment >4mm		34(7.6)	15(6)
Underline disease; n(%)	DM		77 (18)	47 (18.7)
	HTN		147 (32.4)	84 (33.5)
	IHD		23 (5.4)	21 (8.4)
	History of ESWL		178 (39.2)	100 (39.4)
Complication; n(%)	Fever		39 (11.2)	10(4.8)
	Extravasation		1 (0.3)	0 (0)
	Transfusion		41 (11.8)	8 (3.9)
	Sepsis		1 (0.3)	0 (0)
	Gross hematuria(prolonged)		2 (0.6)	0 (0)
	Total		123 (27.2)	32 (12.6)
Degree of hydronephrosis	Sever		55 (17.9)	25 (16.3)
	Moderate		114 (37.1)	67 (43.8)
	Mild		128 (41.7)	52 (34)

DM; diabetes mellitus, HTN; Hypertension, IHD; Ischemic heart disease, URS; Ureterorenoscopy, ESWL; extra-corporeal lithotripsy

Table 2- Complication of qualitative variables post-operative PCNL in patients with/without antibiotic therapy

Variable		Complication	Antibiotic therapy		P-Value
			Yes (n=454/ Group 1)	No (n=254/ Group 2)
Sex; n (%)	Male	With	60(25)	14(10.2)	0.001^*	0.814
		Without	180(75)	123(89.8)
	Female	With	63(29.7)	18(15.7)	0.007^*
		Without	149(70.3)	97(84.3)
BMI group; n (%)	Under weight	With	7(58.3)	1(14.3)	0.147	0.533
		Without	5(41.7)	6(85.7)
	Normal	With	32(26.7)	7(12.3)	0.034^*
		Without	88(73.3)	50(87.7)
	Over weight	With	46(26.6)	17(15.5)	0.04^*
		Without	127(73.4)	93(84.5)
	Obese	With	32(27.4)	6(8.6)	0.002^*
		Without	85(72.6)	64(91.4)
Outcome; n (%)	Stone-free	With	95(24.4)	28(12.4)	0.000^*	0.478
		Without	294(75.6)	198(87.6)
	Residual fragment <4mm	With	11(50)	1(11.1)	0.101
		Without	11(50)	8(88.9)
	Residual fragment >4mm	With	17(50)	2(13.3)	0.015^*
		Without	17(50)	13(86.7)
Underline disease; n (%)	DM	With	23(30.3)	7(14. 9)	0.054
		Without	53(69.7)	40(85.1)
	HTN	With	39(26.7)	10(12)	0.009^*
		Without	107(73.3)	73(88)
	IHD	With	7(30.4)	1(5)	0.050^*
		Without	16(69. 6)	19(95)
	History of ESWL	With	51(28.8)	13(13)	0.003^*
		Without	126(71. 2)	87(87)
Hydronephrosis; n (%)	Sever	With	10(18.2)	3(12)	0.745	0.000*
		Without	45(81.8)	22(88)
	Moderate	With	34(30.1)	5(7.6)	0.000^*
		Without	79(69.9)	61(92.4)
	Mild	With	31(24.4)	6(11.5)	0.054
		Without	96(75.6)	46(88.5)
	Total	With	78(26.2)	15(10.5)	0.000^*
		Without	220(73.8)	128(89.5)

* Significant

BMI, body mass index; JJ, double J ureteric catheter; C/S, culture and sensitivity test; DM, diabetes mellitus.

Table 3- Complication of quantitative variable post-operative PCNL in patients with/without antibiotic therapy

Variable	Complication	Antibiotic therapy		P-Value
Variable	Complication	Yes (n=454/ Group 1)	No (n=254/ Group 2)	P-Value
Age; Mean (SD)	With	48.41(13.3)	48.81(10.46)	0.998	0.004^*
Age; Mean (SD)	Without	49.33(12.15)	51.97(12.38)	0.005^*	0.004^*
Hemoglobin. (g/dL), Mean (SD	With	10.48(1.86)	11.22(2.24)	0.097	0.000^*
Hemoglobin. (g/dL), Mean (SD	Without	11.95(1.6)	12.55(1.69)	0.000^*	0.000^*
Serum Creatinine (mg/dl), Mean (SD)	With	1.14(0.36)	0.98(0.16)	0.013^*	0.060
Serum Creatinine (mg/dl), Mean (SD)	Without	1.29(3.88)	1.06(0.56)	0.485	0.060
Stone size (mm), Mean (SD)	With	34.61(14.64)	31.2(15.96)	0.105	0.333
Stone size (mm), Mean (SD)	Without	33.07(13.24)	32.97(13.86)	0.722	0.333
Duration of the operation (min), Mean (SD)	With	47.09(16.67)	48.91(16.69)	0.476	0.718
Duration of the operation (min), Mean (SD)	Without	44.86(19.08)	45.71(18.22)	0.619	0.718
Total hospitalization (days), Mean (SD)	With	4.92(2)	2.88(1.79)	0.000^*	0.000^*
Total hospitalization (days), Mean (SD)	Without	3.67(1.51)	2.17(1.51)	0.000^*	0.000^*
Hospitalization after operation (days), Mean (SD)	With	3.66(1.64)	2.23(1.19)	0.000^*	0.000^*
Hospitalization after operation (days), Mean (SD)	Without	2.52(1.03)	1.68(0.9)	0.000^*	0.000^*

* Significant

No competing interests reported.

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The effect of antibiotic therapy before percutaneous nephrolithotomy on the frequency of postoperative complications

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