Enhanced recovery after surgery nursing, a risk factor for stoma-related complications in patients with low rectal cancer


 Background: This study aimed to investigate the association between enhanced recovery after surgery (ERAS) nursing and stoma-related complications (SRCs) and prognosis in patients with low rectal cancer (LRC) undergoing abdominoperineal resection with sigmoidostomy.Methods: LRC patients who underwent elective abdominoperineal resection with sigmoidostomy between May 2016 and May 2019 were retrospectively enrolled. The occurrence of early major or minor SRCs (within postoperative 30 days) was set as the primary end-point. Clinicopathological variables and laboratory tests were compared between patients with or without SRCs. The univariate and multivariate logistic regression analyses were performed to investigate risk factors for SRCs. Hospitalization satisfaction-related and prognosis-related variables were compared between LRC patients with or without ERAS nursing.Results: A total of 288 patients were enrolled and the incidence of SRCs was 26.7% (77/288). ERAS nursing was the only independent risk factor for SRCs in LRC patients (OR: 2.04, 95%CI: 1.31-3.12, P=0.016) by the multivariate logistic regression analysis. Moreover, ERAS nursing was associated with higher hospitalization satisfaction rate, faster bowel function recovery, better psychological status, and higher quality of life.Conclusions: ERAS nursing was a risk factor for SRCs and associated with improved prognosis in LRC patients undergoing elective abdominoperineal resection with sigmoidostomy.


Introduction
Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer-related death worldwide with over 1.8 million new cases and 881,000 cancer-related death in 2018 (1). The incidence of low rectal cancer (LRC) among Chinese is reported to be 60-75% higher than Western populations (2,3). As for those LRC patients, abdominoperineal resection with sigmoidostomy is widely accepted as an effective and safe surgical strategy and considered as the standard treatment to decrease the risk of positive distal edge (4). A stoma is a physical and psychological burden for the patients to accept this anatomical change. The reported rates of stoma-related complications (SRCs) are quite high, ranging from 21%-70% (5, 6). Furthermore, its real frequency is probably underestimated due to the autonomous management by stoma therapist without records. SRCs may have a great impact on the postoperative recovery, morbidity, mortality, and quality of life (QOL) (7)(8)(9). Therefore, to investigate potential predictors and effective preventive measures for SRCs is of great clinical importance for prognosis improvement.
Enhanced recovery after surgery (ERAS), which was rst put forward by Kehlet in the mid-1990s (10), has shown notably promising results in reducing the length of stay (LOS) and morbidity after colorectal surgery (11,12). A recent meta-analysis by Lau  health, social function, and subjective symptoms at 3 months after the surgery.
As described by previous reports, the primary observational end-point was the occurrence of early major or minor SRCs (within postoperative 30 days). In brief, major SRCs included stoma prolapse, parastomal hernia, stricture, stula, retraction, ischemia, and bleeding. Minor SRCs included skin alterations according to the classi cation by SACS™ instrument (ConvaTec, Reading, Berkshire, UK) for assessing peristomal skin lesion (18).
The base area of stoma was measured postoperatively by nurses calculating from the horizontal and vertical size of the stoma base. The pathological TNM stage was identi ed according to the criteria by the American Joint Committee on Cancer/International Union Against Cancer (7th edition).

Statistical analysis
GraphPad Prism 8.0 (GraphPad Inc., CA, USA) and SPSS 19.0 (SPSS Inc., Chicago, IL, USA) were used for data analysis. Data are expressed as number (n) with percentage (%) or mean with standard deviation (SD) as appropriate. Data are analyzed using the Chi-square test, Student's t-test, and Mann-Whitney Utest as appropriate. The univariate and multivariate logistic regression analyses were performed to investigate risk factors for SRCs. A two-sided P value < 0.05 was considered statistically different.

Patient characteristics
Three hundred and thirty-three LRC patients who underwent elective abdominoperineal resection with sigmoidostomy were initially enrolled. Forty-ve were excluded due to the following reasons (10 with surgical contraindication, 6 undergoing emergency operations, 5 with malignancies in other systems, 9 with severe hematological, hepatic, or kidney disorder, and 15 with incomplete data) and two hundred and eighty-eight subjects were included in the analysis. The mean age of the cohort was 66.2 years and the majority (69.4%, 200/288) were male patients. The total incidence of SRCs was 26.7% (77/288). The clinicopathological characteristics associated with SRCs are shown in Table 1. There were no signi cant differences in gender, ASA grade, smoking and drinking habits, serum CEA, T stage, N stage, TNM stage, pathologic differentiation, surgical approach, estimated blood loss, and height of stoma between patients with and without SRCs (P > 0.05). Patients in the SRCs group seemed to have a higher percentage of elderly (≥ 65 years) (P = 0.048) and overweight (BMI > 24.5) (P = 0.031). Patients with a higher NRS 2002 score (≥ 3) (P = 0.015), the base area of stoma (P = 0.019), and longer operation time (P = 0.028) were associated with SRCs occurrence. Moreover, signi cant differences were noted for ERAS nursing (P = 0.010) and preoperative stoma localization (P = 0.040) between patients who developed SRCs or not. Laboratory Variables Associated With Srcs Table 2 presents the preoperative levels of laboratory variables in patients with or without SRCs. The results indicated that patients with SRCs had higher rates of abnormal Alb (< 35.0 g/L) and CRP (> 0.8 mg/L) expressions (P = 0.025 and 0.038, respectively). No statistically signi cant differences were observed concerning Hb, WBC, creatinine, and urea between these two groups (P > 0.05).

Risk Factors For Srcs
To identify potential risk factors for SRCs, the univariate and multivariate logistic regression analyses were performed. As illustrated in Table 3, ve variables (age, NRS 2002 score, ERAS nursing, Alb, and CRP) were risk factors associated with SRCs (P < 0.05). Our results from the multivariate logistic regression analysis indicated ERAS nursing as the only independent risk factor for SRCs in LRC patients (OR: 2.04, 95%CI: 1.31-3.12, P = 0.016).

Hospitalization Satisfaction-related Variables And Eras Nursing
Based on the presence of ERAS nursing, enrolled patients were categorized into two groups (188 with ERAS nursing and 100 without). The eleven hospitalization satisfaction-related variables were compared between patients with or without ERAS nursing. As shown in Table 4, patients who underwent ERAS nursing had higher scores of 4 items (comfortableness, communication, emotional support, and participation in nursing) than those without ERAS nursing (P < 0.05).

Prognosis-related Variables And Eras Nursing
The prognosis-related variables between ERAS nursing and non-ERAS nursing groups are listed in Table 5. The time to rst exhaust (P = 0.036) and defecation (P = 0.002), and LOS (P = 0.007) of patients in the ERAS nursing group were all signi cantly lower than those in the non-ERAS nursing group. Moreover, patients who underwent ERAS nursing seemed to have better psychological statuses (higher SAS and SDS scores) and higher quality of life (higher GIQLI scores) than those who did not undergo ERAS nursing (P < 0.05).

Discussion
To our knowledge, this was the rst study to indicate ERAS nursing as an independent risk factor for SRCs. The operation of stoma formation is commonly performed for patients with malignancy and in ammatory bowel disease (IBD) (19). Stoma formation is usually performed after a long and complex surgical operation. This procedure is simply undertaken, but it is associated with signi cant morbidity, complex and life-threatening consequences (20). The incidence of SRCs in LRC patients after abdominoperineal resection with sigmoidostomy was demonstrated to be 26.7% in our cohort. A previous single-center prospective study by Pearson et al. have reported an overall SRCs rate of 23.5% among 408 patients following ostomy surgery over two years (20). Moreover, the incidences between the elective and emergency operation groups were quite similar (20). Another study by Arumugam et al. has elaborated an incidence of 50.5% for one or more SRCs in a prospective study of 97 patients (21). We considered that the differences in stoma location (colostomy or ileostomy), patient characteristics, surgical types, stoma nursing, and SRCs de nitions were probably the main explanations for different incidences in different reports.
Various variables have been identi ed as independent risk factors for SRCs, including ASA grade (22), age, ileostomy, and loop stomas (23), male sex, and ileostomy creation (24 Preoperative nutritional evaluation and support by ERAS nursing can reduce the incidence of insulin resistance and postoperative hyperglycemia, and reduce preoperative anxiety. The improvement of nutritional status is widely reported to be associated with improved systemic immune function and better prognosis (27,28). Stoma formation is also a great threat to QOL for LRC patients due to the low acceptance rate, troublesome stoma nursing, and psychological burden. To some extent, the decreased SRCs rate correlates with increased QOL.
There are some limitations to this study. First, this is a single-center study with a relatively small sample size. Second, the retrospective nature and long-time inclusion period generate some uncontrollable biases. Third, the involved mechanisms remain unknown. Last, only LRC patients were enrolled and whether our conclusions apply to other stoma operations remain uncertain. Considering ERAS nursing can reduce postoperative SRCs, improve the hospitalization satisfaction and QOL, it would be generally desirable.

Conclusions
In conclusion, ERAS nursing was a risk factor for SRCs and associated with improved prognosis in LRC patients undergoing elective abdominoperineal resection with sigmoidostomy.

Declarations
The study was supported by the Taizhou Science and Technology Support Plan (social development) (No. TS201801), and Jiangsu Provincial Medical Youth Talent (QNRC 2016514).

Availability of data and material
Please contact the corresponding author (Guoqin Feng, email: fengguoqin.tz@outlook.com) for data requests.
Authors' contributions WL S, HG W, Q C, and W Z: conception and design, data collection, statistical analysis and wrote the manuscript.
YL G, GQ F: study design, data collection, and study design.

Competing interests
None.

Consent for publication
Not applicable.

Ethics approval and consent to participate
This study protocol was approved by the Medical Institutional Ethics Committee of our hospital. All patients included were required to offer written informed consent.