Cefoxitin versus Cefepime for the Prevention of Perioperative Infection in Elderly Patients Undergoing Colorectal Cancer Surgery: A Retrospective Study

doi:10.21203/rs.3.rs-3815362/v1

Background

The optimal antibiotic prophylaxis in preventing perioperative infection in patients aged 70 who underwent colorectal cancer surgery of are unknown. We conducted a comparative analysis to evaluate the efficacy of cefoxitin and cefepime in preventing perioperative infections and assessed the inflammatory response to antibiotics during the perioperative period.

Methods

Patients over 70 years old and undergo surgery for colorectal cancer between January 2021 and June 2022 at the same ward of a tertiary teaching hospital in Shanghai, China were included. Demographic and clinical data were retrieved from hospital information system (HIS) to evaluate the body reaction of two antibiotic prophylaxis: patients in Group A received cefoxitin and in Group B accepted cefepime after surgery. Both antibiotics were intravenous 2000mg, two times daily, total 3 days. The effect of perioperative prevention was compared between two groups with any infection complications, hospital length of stay (HLOS), postoperative length of stay (POLS) and mortality during hospitalization.

Results

A total of 107 elderly patients (56 patients in Group A and 51 patients in Group B) with colorectal cancer were included. Two groups were similar in terms of tumor stage and other basic demographic. Patients received cefoxitin demonstrated lower infection complications (12.5% vs 13.7%, P = 0.851), among which surgical site infection (SSI) were most frequent complications in both groups (8.5% vs 9.8%, P = 0.877). However, patients with cefepime represented shorter HLOS (14.0 ± 4.7 days vs 13.9 ± 3.8 days, P = 0.912) and PLOS (9.4 ± 3.8 days vs 8.4 ± 2.1 days, P = 0.265). Additionally, the percentage of cluster of differentiation (CD) 4 + cell was significantly higher (29.2%±9.2 vs 46.5%±10.0, P = 0.001) and the percentage of CD8 + cell was statistical lower (26.1% [23.1, 34.4] vs 19.2% [15.5, 20.4], P = 0.004) in Group B compared to Group A at the third postoperative day. No death occurred in both groups.

Conclusion

Cefepime and cefoxitin both serve as useful prophylaxis to reduce infectious complications among elder patients underwent surgery for colorectal cancer. However, cefepime illustrated a more active inflammatory response and might enhance the body recovery in early post-operative rehabilitation.

Cefoxitin

Cefepime

Perioperative prophylaxis

Colorectal cancer surgery

Elderly

Postoperative infections, especially surgical site infections (SSIs), have been associated with increased mortality rates, elevated hospitalization costs, and extended hospital stays. Colorectal surgery is among the procedures with the highest SSI incidence rates, potentially reaching up to 9.5%, even when adhering to antimicrobial prophylaxis guidelines [1–3]. Beyond SSIs, other postoperative infections such as intra-abdominal infections (IAIs), hospital-acquired pneumonia (HAP), and urinary tract infection (UTI) also significantly contributed to hospital readmissions, costs, and mortality [4]. Elderly patients, often presenting with poor nutritional status and comorbidities, are at an increased risk of postoperative infections [5]. Despite this, the majority of studies do not recommend age-based antibiotic prophylaxis, and the optimal regimen for elderly patients remains undetermined. Furthermore, the inflammatory responses to various antimicrobial prophylaxis are linked to biomarkers such white blood cell count (WBC), C-reactive protein (CRP), and lymphocyte subsets [6, 7]. However, few studies focus on the fluctuation in these inflammation profile, particularly in the elder population. This lack of research complicates the selection of perioperative antimicrobial prophylaxis for elderly patients undergoing colorectal cancer surgery.

Previous studies on colorectal surgery have recommended the use of perioperative antibiotics that are effective against enteric Gram-negative bacilli, Enterococcus and anaerobic pathogens [8, 9]. Cefoxitin, a short-acting cephamycin with broad spectrum of antibacterial activity against gram-negative and anaerobic bacteria [10], has been recommended by guidelines in both United States (US) and China to prevent SSIs in colorectal surgery [11, 12]. However, the efficacy of cefoxitin in perioperative setting is unclear in areas with increasing antibiotics resistance of Enterobacteriaceae. In clinical practice, fourth-generation cephalosporins are preferred in institutions with increasing resistance to second- and third-generation cephalosporins, especially in patients with risk factors such as age over 70 or cancer. Cefepime, a representative fourth-generation cephalosporin with good therapeutic efficacy in the treatment of IAIs, HAP and UTI, may be a potential choice for antibiotic prophylaxis in colorectal surgery [13].

Therefore, we conducted this retrospective study to assess the effectiveness of cefepime as a perioperative antimicrobial prophylaxis in elderly patients undergoing surgery for colorectal cancer compared to cefoxitin, and to evaluate the impact of both regimens on the immune system after operation.

Study Design and Setting

This retrospectively study was designed to evaluate and compare the efficacy of cefoxitin and cefepime in preventing infectious complications in patients aged 70 and above, who underwent colorectal cancer surgery. The primary outcome measures encompassed any perioperative infectious complications, hospital length of stay (HLOS), postoperative length of stay (PLOS), and mortality during hospitalization. Secondary outcome measures comprised inflammation-associated biomarkers such as routine blood test, biochemical test, T lymphocyte subgroups, and other general body response to infection, including body temperature, renal and hepatic function. To accurately depict the dynamic changes in response to antimicrobial agents, relevant indicators were monitored preoperatively, on the third postoperative day, and one week postoperatively, respectively.

Inclusion Patients and Perioperative Treatment

Our study incorporated patients aged over 70 years old, diagnosed with colorectal cancer, who underwent elective laparoscopic colorectal resection at Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, from June 2021 to June 2022. Exclusion criteria were as follows: (1) severe liver, kidney, heart or lung, dysfunction, (2) antibiotic usage within 4 weeks preceding administration, (3) a documented history of cephalosporin allergy, (4) patients presenting with perforation and complete bowel obstruction. All patients accepted mechanical bowel preparation with 2L of polyethylene glycol orally on the day preceding surgery and were administered 2g of cefoxitin intravenously at least 30 minutes prior to skin incision. Postoperatively, patients who received 2g of cefoxitin at 12-hour intervals for 3 days were categorized as Group A (n = 56); while those administered 2g of cefepime at 12-hour intervals as a postoperative antibiotic regimen for 3 days were categorized as Group B (n = 51). Detailed information is depicted in Fig. 1. The definition of infectious complications was established based on the presence of the following infections after the operation: SSIs, HAP, IAIs and UTIs. The attending surgeons and nurses conducted daily inspections of patients daily until discharge to identify these infections.

Data Collection and Statistical Analysis

Demographic data, including age, gender, body mass index (BMI), concomitant disease, and tumor stage were collected. Additionally, we obtained the following records from hospital information system (HIS) to assess physical changes: body temperature, white blood cell count (WBC), neutrophilic granulocyte percentage (NEU), and C-reactive protein (CRP), procalcitonin (PCT), liver and renal function, and T lymphocyte levels on the pre-operation day (Pre-O), the third day post-operation (POD-3), and the seventh day post-operation (POD-7). Descriptive statistics were calculated for all variables between the two groups. Mean values and standard deviations were calculated for continuous variables, while counts and percentages for categorical variables. The normality of data sets was assessed using Box plots and histograms. Continuous variables were described as mean ± standard deviation (SD) or median (interquartile range, IQR). Two-sample t-test or Wilcoxon rank-sum test were used to compare continuous variables between the two groups, and Pearson’s Chi-square test was used for categorical variables. All statistical analyses were performed using SPSS 24.0 statistical package (SPSS, Chicago, IL, USA). A significance level of P < 0.05 was considered statistically significant.

Baseline Characteristics of Included Patients

A total of 107 patients aged over 70 with colorectal cancer who underwent elective laparoscopic colorectal resection between January 2021 and June 2022 were included in the study. The patients were divided into two group based on their antibiotic prophylaxis regimen: Group A (56 patients) received cefoxitin, and Group B (51 patients) received cefepime for 3 days after surgery. Demographic data are summarized in Table 1. All included patients had colorectal tumor stage II or III based on histopathological results. There were no significant differences between the two groups in terms of age, gender, body mass index, concomitant disease, and tumor stage. None of the patients in either group had taken corticosteroids, or other immunosuppressive agents, or chemotherapy regimens before or during hospitalization.

Key Outcomes of Perioperative Antimicrobial Prophylaxis

The preventive outcomes of perioperative prophylaxis were presented in Table 2. The incidences of overall postoperative infection complications of Group A was 12.5%, while in Group B it was 13.7%, with no statistical difference between the two groups. Furthermore, there were no significant differences observed in SSIs, HAP, IAIs, and UTIs during the colorectal perioperative period between the two groups. The most common infection complication in both groups was SSIs, with rates of 8.9% in Group A and 9.8% in Group B. Patients receiving cefepime (Group B) had shorter hospitalization (14.2±4.7 vs 13.8±3.8) and postoperative hospital stay (9.5±3.8 vs 8.7±2.0), although these differences were not statistically significant. No cases of UTI or death were observed during hospitalization in either group.

Secondary Outcomes Associated with Response to Perioperative Antimicrobial Prophylaxis

Prior to the operation, there was no significant difference in the laboratory parameters indicative of infections and inflammatory changes, body temperature, and renal and hepatic function between Group A and Group B at Pre-O (Table 3). However, on POD-3, the percentage of cluster of differentiation (CD) 4+ cell in Group B (46.5±10.0) were significantly higher than Group A (29.2±9.2, P=0.001), while the percentage of CD8+ cell in Group B (19.2[15.5, 20.4]) was significantly lower than in Group A (26.1[23.1, 34.4], P=0.004). Furthermore, on POD-7, there were no significant differences in any of the laboratory parameters between two groups. The dynamic changes of the patient's immune cell examination with cefepime were shown in Figure 2.

Recent clinical guidelines for antibiotic prophylaxis in colorectal procedure recommended agents such as the first- and second-generation cephalosporins ± metronidazole, and other evidence-based antibiotics, with cefoxitin being one of the most frequently utilized in clinical practice [11, 14, 15]. However, these existing agents do not take into account the risk stratification of patients. For instance, elderly patients with colorectal cancer will experience decrease of immunity, which can affect the prophylactic effect of antibiotics [14, 15]. Moreover, previous principles of perioperative antibacterial prophylaxis included studies based on outdated bacterial resistance data. However, bacterial distribution and antibiotic resistance vary by region, for example, China posed significant therapeutic challenges in the rapid proliferation of antimicrobial resistant Gram-negative bacteria [16]. Consequently, the selection of appropriate antibiotics for patients with varying risks and regional differences requires further clinical evidence. Cefepime is widely recommended for the treatment of various infections, including but not limited to pneumonia, sepsis, IAI. However, the efficacy of cefepime as prophylactic antibiotics in elective colorectal procedure remains unexplored. We compared the infection prevention capabilities of cefepime and cefoxitin in elderly patients with an average age over 75, and underwent surgery for colorectal cancer. We found that the overall infection rate reached over 10% even with the fourth generation cephalosporins for infectious prophylaxis, which indicating we can’t rely on antibiotics solely to reduce the perioperative infection.

The innate responses of pathogen are generally evaluated by biomarkers such as PCT, CRP, and WBC count based on risk of infectious complications and provided early opportunity for effective medical support [17, 18]. Our study demonstrated that biomarkers PCT, CRP, and WBC count in both groups were higher in early postoperative period compared with pre-operation, and did not return to normal until the seventh day post operation. Other biomarkers such as lymphocyte subsets, especially the main lymphocyte subpopulations (CD4+, CD8+), were crucial in the different stages in the host defense. However, prior studies comparing CD4 + and CD8 + lymphocyte counts have primarily focused on patients with pulmonary tuberculosis (TB) or human immunodeficiency virus (HIV) [6, 7, 19]. Our findings revealed that CD4 + and CD8 + level value varied in early postoperative period with different antibiotics for prophylaxis.

Both CD4 + and CD8 + plays a crucial role in immune defense against viruses, intracellular bacteria, and tumors. Previous research has indicated that alterations in CD4 + and CD8 + values typically occur in an opposite manner, thereby coordinating the regulation of immunity function [20]. Certain antibiotics, such as macrolides, exhibit potent and extensive immunomodulatory effects through various mechanisms, which facilitate the restoration of immune homoeostasis and bolster key antimicrobial defences[21]. In vitro, azithromycin suppresses CD4 + T-cell activation by directly modulating mTOR activity, potientially further diminishing the activation and mobilization of neutrophils [22]. Furthermore, it reported that low-dose azithromycin enhances CD8 T-cell granzyme B in patients with chronic obstructive pulmonary disease (COPD) [23]. β-lactams, apart from their antibacterial properties, have also been investigated for their immunomodulatory effects including allergic responses [24]. For instance, an in vitro study reported that clavulanic acid and cefoxitin were the most potent inhibitors of IFN-g activity, as assayed by the induction of CD54 on the surface of the lung epithelial cell line A549 [24]. Another reported β-lactams to possess both antibacterial and immunomodulatory functions was cefodizime, it can enhance the CD4 + value in elderly patients with community-acquired pneumonia (CAP) [25, 26]. However, the mechanism in immune response of antibiotics remain incompletely understood in both vitro and in vivo studies. To the best of our knowledge, our research is the first to evaluate antimicrobial prophylaxis with combined outcomes of both infection complications and immune response in elderly. We corroborated that compared to cefoxitin, which might be a potent inhibitor for IFN-g activity, cefepime can enhance the percentage of CD4 + cells (46.5 ± 10) and reduce the percentage of CD8 + cells (19.2[15.5, 20.4]) at POD-3. The phenomenon suggesting that cefepime can improve cellular immunity and have a positive effect during the initial postoperative period in elderly patients undergoing colorectal cancer surgery.

Our retrospective analysis also revealed that although cefoxitin exhibited a lower incidence of postoperative infectious complications compared to cefepime, patients receiving cefoxitin had longer HLOS and PLOS. Notably, these differences between the two groups were no statistically significant. Moreover, no significant difference was found in T lymphocytes at one week after surgery with both cefepime and cefoxitin. Therefore, cefepime was considered as efficiency as cefoxitin in preventing infectious complications in colorectal surgery, and it also enhance immunomodulatory properties in early postoperative recovery. We may need to consider the immunomodulation by antibacterial agents in the selection of antibiotics for perioperative prophylaxis in the future. No adverse events were reported and there is no obvious difference in safety between cefepime and cefoxitin.

The main limitation of this study was largely attributable to its small sample size. A total of 107 patients in our hospital at the same ward were involved in this study. Systematic measures such as nursing process after operation also have an important effect on SSI rate and the systematic measures in different medical institutions varies. Thus, may have an impact on the infectious complications result. Another limitation was the nature of retrospective study. For example, the CD4 + and CD8 + data in POD-3 were significant different between two groups and further analysis required detailed immune-related cell test which were lacing. Future research should continue to elucidate optimal prophylaxis regimens which could widely applied to other institutions with implementation of quality control measures and immune mechanisms in the pathogenesis of postoperative infectious complications.

As a perioperative prophylaxis agents, cefepime did not have more advantages in reducing infectious complications compared with cefoxitin among elder patients with colorectal cancer underwent surgery for treatment. However, cefepime have positive effects on immune responses at the early postoperative period.

CD, cluster of differentiation; COPD, chronic obstructive pulmonary disease; CRP, C-reactive protein; HAP, hospital-acquired pneumonia; HIS, hospital information system; HIV, human immunodeficiency virus; HLOS, hospital length of stay; IAIs, intra-abdominal infections; IQR, interquartile range; NEU, neutrophilic granulocyte percentage; PCT, procalcitonin; Pre-O, the pre-operation day; POD-3, the third day post-operation; POD-7, the seventh day post-operation; POLS, postoperative length of stay; SD, standard deviation; SSIs, surgical site infections; UTI, urinary tract infection; US, United States; WBC, white blood cell count.

Ethics approval and consent to participate: This retrospective study was conducted based on data from medical records and with the approval of the Ethics Committee of Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine. The need for written informed consent was waived due to the retrospective nature of the study.

Consent for publication: Not applicable.

Availability of data and materials: All data included are available from the corresponding author on reasonable request.

Competing interests: The authors declare that they have no competing interests.

Funding: None.

Authors’ contributions: 1) Yangxi Liu and Yang Luo designed and performed data analysis of the study; 2) Zaili Zhang collected the data; 3) Jing Xu, Bisheng Shi and Xiaojun Ni helped in solving professional and statistical problems encountered during the work.

Acknowledgements: All authors would like to thank the medical statistician for their support and assistance to this research.

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Table 1 Baseline characteristics of patients

Variables	Group A (n=56)	Group B (n=51)	P value
Age(years)	77.0±4.5	78.7±5.5	0.117
Gender, n (%)			0.263
Male	28(50.0)	31(60.8)
Female	28(50.0)	20(39.2)
BMI (kg/m²) *	22.2±4.4	22.4±3.6	0.933
Concomitant disease, n (%)
Diabetes mellitus	9(16.1)	12(23.5)	0.332
Hypertension	21(37.5)	27(52.9)	0.109
Cardiac disease	14(25.0)	12(23.5)	0.859
Cerebral infarction	4(7.1)	4(7. 8)	0.891
Pulmonary disease	2(3.6)	4(7.8)	0.337
Surgery	10(17.2)	11(19.6)	0.741
Immune system disease	4(7.1)	4(7.5)	0.891
Tumor stage			0.703
Ⅱ	29(64.4)	16(35.6)
Ⅲ	26(68.4)	12(31.6)

Proportions presented as number (percentage %), * Wilcoxon rank-sum test, BMI = body mass index.

Table 2 Primary postoperative outcomes

Variables	Group A (n=56)	Group B (n=51)	P value
HLOS (days)	14.2±4.7	13.8±3.8	0.823
PLOS (days)	9.5±3.8	8.7±2.0	0.668
Overall failure of prevention (%)	7(12.5)	7(13.7)	0.851
SSI	5(8.9)	5(9.8)	0.877
HAP	0(0.0)	2(3.9)	0.135
IAI	2(3.6)	0(0.0)	0.173
UTI	0	0
Postoperative mortality (%)	0	0

Proportions presented as number (percentage %), HLOS = hospital length of stay, HAP = hospital-acquired pneumonia, IAI = intra-abdominal infection, PLOS = postoperative length of stay, SSI= surgical site infection, UTI = urinary tract infection.

Table 3 Details of Secondary postoperative outcomes

Variables	Pre-O				POD-3			POD-7
Variables	Group A (n=56)	Group B (n=51)	P value	Group A (n=56)		Group B (n=51)	P value	Group A (n=56)	Group B (n=51)	P value
Blood Routine and Biochemical Test
WBC (*10⁹/L)	6.2[5.2,7.7]	5.4[5.2,7.7]	*0.130	10.9[8.6,12.8]		11.0[7.8,12.9]	*0.897	7.5[6.1,8.8]	6.2[5.0,8.4]	*0.069
NEU (%)	64.6[57.9,70.3]	63.8[55.3,74.6]	*0.977	86.0[83.2,89.2]		87.6[81.3,89.5]	*0.904	78.0[71.9,84.3]	73.6[65.9,83.1]	*0.078
CRP (mg/L)	0.7[0.5,3.7]	1.8[0.5,8.9]	*0.260	43.0[22.1,85.6]		41.8[24.5,101.5]	*0.297	68.6[21.5,109.9]	34.9[23.4,66.8]	*0.122
PCT (ng/ml)	0.03[0.02,0.05]	0.04[0.02,0.07]	*0.508	0.3[0.2,0.9]		0.8[0.3,2.3]	*0.297	0.2[0.1,0.6]	0.3[0.1,0.8]	*0.149
Body Temperature (℃)	37.0±0. 4	37.0±0.4	0.813	37.6±0. 5		37.4±0. 6	0.067	37.0[36.7,37.5]	37.0[36.8,37.3]	*0.765
Renal Function
Scr (μmol/L)	74 [61,79]	74[63,89]	*0.434	67 [61,79]		74[59,88]	*0.288	64 [55,74]	75 [56,87]	*0.075
UA (μmol/L)	298.2±88.6	323.1±98.5	0.179	232 [191,271]		240[182,286]	*0.739	138 [111,199]	181 [108,273]	*0.326
Hepatic Function
ALT (U/L)	11[8,16]	9[7,14]	*0.102	12 [8,16]		9 [7,14]	*0.079	11 [8,22]	10 [7,20]	*0.272
AST (U/L)	16[14,20]	15[13,18]	*0.352	15 [13,19]		16 [12,23]	*0.844	15 [13,24]	15 [12,23]	*0.744
DB (μmol/L)	3.7[2.6,4.7]	3.6[2.9,5.1]	*0.418	4.2[3.2,6.4]		4.7[3.5,6.8]	*0.411	4.9 [3.6,6.5]	4.9 [3.8,7.5]	*0.893
TB (μmol/L)	9.4[6.6,12.9]	10.3[7.0,16.1]	*0.283	11.9[7.5,15.6]		12.8[8.6,18.7]	*0.341	11.4 [8.5,16.5]	11.7 [8.6,19.5]	*0.580
ALB (g/L)	39.6[36.6,42.6]	38.3[35.6,41.6]	*0.362	33.0[30.7,35.0]		31.9[28.2,35.8]	*0.672	35.6±4. 1	36.1±4. 1	0.515
T Lymphocytes (%)
CD3+ cell	63.6±9.5	65.2±12.2	0.587	58.4[56.4,70.7]		68.0[67.2,72.7]	*0.102	68.8±8.3	65.9±11.0	0.495
CD4+ cell	38.4±7.0	41.4±9.3	0.182	29.2±9.2		46.5±10.0	0.001	44.2±9.2	44.7±7.5	0.890
CD8+ cell	25.5[18.0,30.7]	17.9[15.1,23.2]	*0.131	26.1[23.1,34.4]		19.2[15.5,20.4]	*0.004	23.7±6.5	19.8±8.6	0.246

ALB = albumin, ALT = alamine aminotransferase, AST = aspartate aminotransferase, CRP= C-reactive protein, DB = direct bilirubin, NEU = neutrophilic granulocyte percentage, PCT = procalcitonin, Pre-O= Pre-operation, POD-3= the third day post-operation, POD-7= the third day post-operation, TB = total bilirubin, Scr = Serum Creatinine, UA = Uric acid, WBC= white blood cell count.

* Wilcoxon rank-sum test.

Font bold of P-values indicated that there was a statistically significant difference between two groups.

No competing interests reported.

Cefoxitin versus Cefepime for the Prevention of Perioperative Infection in Elderly Patients Undergoing Colorectal Cancer Surgery: A Retrospective Study

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Introduction

Methods

Study Design and Setting

Inclusion Patients and Perioperative Treatment

Data Collection and Statistical Analysis

Results

Discussion

Conclusion

Abbreviations

Declarations

References

Tables

Additional Declarations

Status:

Version 1