
==== Front
Int J Surg
Int J Surg
JS9
International Journal of Surgery (London, England)
1743-9191
1743-9159
Lippincott Williams & Wilkins Hagerstown, MD

38833328
IJS-D-24-00537
10.1097/JS9.0000000000001758
00024
3
Original Research
A new simplified risk assessment model enhances postoperative prophylaxis of venous thromboembolism in Chinese adult patients with inguinal hernia (CHAT-3): a prospective, multicenter, randomized controlled trial
Gu Zhi-Chun MS abc*guzhichun213@163.com

Dai Meng-Fei MS ddmf9609@163.com

Hu Meng PhD humengiloveyou88@126.com
ab
Yan Yi-Dan MS abyanyidan_cpu@163.com

Lin Hou-Wen PhD abfranklin67@126.com

Zhang Li MS ezhangli6086@163.com

Zhang Zi-Chao MS fzzc81518@163.com

Liu Chang MD gchangliu72@163.com

Ning Ning PhD hningning301@126.com

Zhang Hui MS i15038169036@163.com

Zhang Nan MD jzhangnan1975man@sina.com

Che Yan PhD kcheyan2004@163.co

Li Jian-Wen MD lljw5@yeah.net

Wang Ming-Gang MD m*wmgonly@126.com

Liu Yu-Chen MD m*Lionkingchen@foxmail.com

and for the CHAT-3 investigators
a Department of Pharmacy, Punan Branch of Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
b Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
c College of Clinical Pharmacy, Shanghai Jiao Tong University School of Medicine, Shanghai, China
d Department of Pharmacy, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, Zhejiang Province, China
e Department of Pharmacy, The Second Affiliated Hospital of Xi’an Jiao Tong University, Xi’an, Xi’an, Shanxi Province, China
f Department of General Surgery, Digestive Medical Center, The First Affiliated Hospital, School of Medicine, Tsinghua University, Beijing, China
g General Surgery, the Fourth Affiliated Hospital of Harbin Medical University, Harbin, China
h Department of Gastrointestinal Surgery, International Hospital of Peking University, Beijing, China
i Department of Gastrointestinal Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan Province, China
j Department of General Surgery, Tianjin Nankai Hospital, Tianjin, China
k NHC Key Lab of Reproduction Regulation, Shanghai Institute for Biomedical and Pharmaceutical Technologies, Shanghai, China
l Department of General Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
m Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
* Corresponding author. Address: Department of Pharmacy, Punan Branch of Renji Hospital, Shanghai Jiao Tong University School of Medicine/Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine/College of Clinical Pharmacy, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, People's Republic of China. Tel.: +86 021 683 856 52. E-mail: guzhichun213@163.com (Z.-C. Gu); Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, People's Republic of China. Tel.: + 86 010 517 18355. E-mail: wmgonly@126.com (M.-G. Wang), and E-mail: lionkingchen@foxmail.com (Y.-C. Liu).
9 2024
4 6 2024
110 9 55385544
10 2 2024
20 5 2024
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0/

Background:

Venous thromboembolism (VTE) significantly affects the prognosis of surgical patients with inguinal hernia. The complex Caprini score, commonly used for postoperative VTE risk assessment, poses practical challenges for surgeons in clinical settings.

Methods:

The CHAT-3 trial, a prospective, multicenter, randomized controlled trial, compared a simple three-factor model to assess VTE risk against routine practices in postinguinal hernia surgery (IHS) patients. The patients were randomly assigned (1:1) to the intervention or control arm. The intervention group used the three-factor model to identify patients at moderate or high risk of VTE for subsequent prophylaxis according to clinical guidelines. Both groups were followed for 4 weeks, with randomization implemented using computer-generated sequences. The primary outcome measured was the rate of VTE prophylaxis. Secondary outcomes included time spent on VTE risk assessment (surgeon self-reported), postoperative D-dimer trends, perioperative VTE occurrence, bleeding events, and the net clinical benefit.

Results:

Of the 1109 participants, 508 in the experimental group and 601 in the control group completed follow-up. The three-factor model showed higher VTE prophylaxis rates in all patients (pharmacologic prophylaxis: 26.2 vs. 6.00%, P<0.001) and particularly in those at high risk (pharmacologic prophylaxis: 57.3 vs. 9.50%, P<0.001). The experimental group significantly reduced VTE risk assessment time compared to the Caprini score (1.39±0.55 min vs. 5.73±1.35 min, P<0.001). The experimental group had lower D-dimer levels (0.26±0.73 mg/l vs. 0.35±0.55 mg/l, P=0.028). In the experimental group, the patients did not experience an increased risk of VTE (0 vs. 1.66%, P=0.268) and bleeding (1.18 vs. 0.67%, P=0.558) compared to the controls. There was no significant difference in net clinical benefit, which combined VTE and bleeding events, between the experimental and control groups (1.18 vs. 0.83%, P=0.559).

Conclusion:

Applying the simple three-factor model in perioperative VTE management could quickly identify the patient with a high risk of VTE and improve the prophylaxis rate of perioperative VTE.

Keywords:

inguinal hernia
management
net clinical benefit
pharmacologic prophylaxis
randomized controlled trial
risk assessment model
venous thromboembolism (VTE)
OPEN-ACCESSTRUE
SDCT
==== Body
pmcIntroduction

Highlights

After inguinal hernia surgery, 23.4% of patients assessed venous thromboembolism (VTE) risk and only 13.2% received prophylaxis.

A new three-factor risk assessment model can significantly increase perioperative prophylaxis rate of VTE, particularly for high-risk patients.

This study underscores the model’s potential utility in improving patient outcomes by facilitating more effective VTE risk assessment in surgical settings.

Inguinal hernia repair is one of the most frequently performed surgeries worldwide, with an estimated 20 million procedures annually1,2. Venous thromboembolism (VTE) represents a potentially serious postoperative complication and a common cause of mortality after surgery3,4. Our previous study (CHAT-1), which included 14 322 inguinal hernia patients in 58 hospitals in China, reported a VTE incidence of 0.2%5. This incidence increased to 11.5% in patients over 60 years of age6. Given the substantial volume of inguinal hernia surgeries and the associated high risk of VTE, prophylaxis for perioperative VTE in these patients is crucial.

An accurate perioperative assessment of VTE risk is essential for implementing effective prevention strategies. The Caprini risk score, developed for the postoperative evaluation of VTE risk and widely used, includes 39 factors and a section for additional risks. However, its complexity hinders its practical application in clinical settings7. This complexity has significantly reduced its adoption by surgeons, leading to a considerable under-assessment of VTE risk5. In the CHAT-1 trial, only 23.4% of inguinal hernia patients underwent perioperative Caprini risk assessment, and many were incorrectly assessed for VTE5. Therefore, there is an imperative need for more straightforward methods to identify high-risk patients requiring intensified anticoagulant prophylaxis. Multiple analytical methods, including logistic regression, decision trees, and three machine learning models, were used to analyze the CHAT-1 trial data to identify related risk factors8–10. A modified Delphi method was used to drive consensus on three critical predictors of perioperative VTE in patients following inguinal hernia surgery: age over 60 years, history of VTE, and operation duration ≥45 min11, indicating its simplicity in identifying high-risk patients. However, this simplified three-factor model has not yet been validated in clinical practice.

To address this, we initiated the CHAT-3 study. This study used the straightforward three-factor model to identify patients at moderate or high risk for VTE after inguinal hernia surgery (IHS). These patients received VTE prevention according to clinical guidelines3,12,13, contrasting with current routine Caprini assessment and practices.

Methods

Study design and patients

The CHAT-3 trial was a prospective, multicenter, randomized, parallel-group study conducted in nine hospitals in China6. The study included patients aged 18–80 years who were admitted to the general surgery department for IHS. Key exclusion criteria were as follows: 1) previous diagnosis of VTE or current anticoagulation treatment, 2) any surgery in the last 3 months, 3) a history of hematologic disease or blood coagulation dysfunction, 4) impaired liver function (alanine aminotransferase levels ≥3 times the upper normal limit), 5) impaired renal function (estimated glomerular filtration rate <30 ml/min/1.73 m2], 6) concurrent heart failure, respiratory failure, or refractory hypertension, 7) contraindications to anticoagulation, known allergy to heparin, or a history of heparin-induced thrombocytopenia, 8) active malignant tumor, 9) pregnancy or lactation, and 10) contraindications to IHS.

This study adhered to the principles of good clinical practice and the Declaration of Helsinki. The protocol received approval from the Ethics Committee of the Beijing Chaoyang Hospital, Capital Medical University, and was registered in the Chinese Clinical Trial Registry (ChiCTR2000033769). All patients provided written informed consent before participating in any study-related procedures. The work has been reported in line with the CONSORT guidelines14 (Supplemental Digital Content 1, http://links.lww.com/JS9/C696).

Procedures

Eligible patients were randomly assigned (1:1) to the intervention or control arm using random envelope at each center. This open-label study did not mask participants, investigators, or data analysts from allocation. The patients in the intervention group followed a specific protocol (Fig. 1). Before surgery, they underwent a vascular ultrasound screening for VTE and a review of the use of antithrombotic drugs. Postoperatively, patients were assessed for perioperative VTE risk factors (age >60 years; history of VTE/VTE in the family/thrombophilia; surgery duration ≥45 min) and bleeding risk factors (age >75 years, previous bleeding episodes, cancer, renal or liver failure, etc.) according to the CHEST guideline on antithrombotic therapy. High-risk bleeding was identified in patients with two or more risk factors for bleeding. Patients with two or three risk factors for VTE were considered moderate to high risk for VTE. These patients received pharmacological prophylaxis with low-molecular-weight heparin (LMWH) for 5–7 days unless they were at high risk of bleeding or declined pharmacological thromboprophylaxis. Patients with fewer than two risk factors for VTE or a high risk of bleeding did not receive pharmacological prophylaxis.

Figure 1 The flow chart of venous thromboembolism management in patients with hernia surgery.

Additionally, the intervention group received intensive VTE education and follow-up 1 and 4 weeks after surgery. The control group underwent current routine assessment and practice, with follow-up at 4 weeks postoperatively.

Development of the simplified three-factor model

A previous study, CHAT-1, was conducted in which a total of 13 886 patients with inguinal hernia were admitted to 58 participating hospitals. This study investigated the current prevalence of early perioperative VTE and risk factors among Chinese adult patients. Using data from the CHAT-1 study, various analytical methods, including logistic regression, decision trees, and three machine learning models (random forest, support vector machine, and TabNet), were used to identify multiple risk factors for VTE (Supplementary Table 1, Supplemental Digital Content 2, http://links.lww.com/JS9/C697).

However, the multitude of identified risk factors was not suitable for clinical application. To develop a simple and practical model for use in research centers, a modified Delphi method was conducted. A CHAT-3 expert panel consisting of 42 specialists in related fields, including surgeons, anticoagulant pharmacists, nurses, and managers (Supplementary Table 2, Supplemental Digital Content 2, http://links.lww.com/JS9/C697), was assembled to achieve consensus on a perioperative VTE prediction model for inguinal hernia surgery (Supplementary Table 3, Supplemental Digital Content 2, http://links.lww.com/JS9/C697). The final model was simplified to include three key factors: 1) age over 60 years; 2) personal or family history of VTE or thrombophilia; 3) surgery duration ≥45 min.

The simplified three-factor model was tested for its performance based on CHAT-1 data and compared with the commonly used Caprini score. The results indicated that the simplified model performed similarly to the Caprini score, which categorizes a score of 5 or higher as high risk for VTE, in terms of accuracy (50.25 vs. 49.22%), precision (0.26 vs. 0.25%), and recall (93.75 vs. 93.75%) (Supplementary Table 4, Supplemental Digital Content 2, http://links.lww.com/JS9/C697). However, the streamlined nature of the three-factor model is more user-friendly and better meets the needs of clinical practice.

Outcomes

The primary outcome was the VTE prophylaxis rate, including pharmacological and mechanical methods. Secondary outcomes included time spent on VTE risk assessment (surgeon self-reported), postoperative D-dimer trends within the first week, perioperative VTE occurrences, bleeding events, and the net clinical benefit from combining VTE and bleeding events. Subgroup analyses were conducted based on age, sex, BMI, diagnosis, D-dimer levels, and duration of operation.

Statistical analysis

We estimated a requirement of 1106 patients for the trial, with ~553 participants in each arm. Based on our previous study’s findings, only 13% patients undergoing IHS received prophylactic measures. For the intervention arm, we hypothesized that the appropriate prophylactic measures would be administered to 23% of the patients. Under the assumption of superiority (by a margin of 2.5%), the estimated sample sizes considered a two-sided 5% significance level, power of 90%, and allowed up to 20% losses to follow-up. The sample size calculation was performed using the PASS software version 15.

The outcomes and patient characteristics were analyzed on an intention-to-treat basis, which included all patients randomly assigned to either study arm, regardless of whether they declined the recommended thromboprophylaxis regimen.

Categorical data are reported as numbers and percentages, and comparisons were made using the χ 2 test. Continuous variables are presented as means±SD. P-values are two-tailed, with a significance level set at 5%. The risk difference and its 95% CI were calculated.

Results

From 1 June 2020 to 30 June 2021, 1439 patients were screened. Among these, 1234 eligible patients were assigned to the experimental or control groups. Follow-up was completed by 508 patients in the experimental group and 601 in the control group (Supplementary Figure 1, Supplemental Digital Content 2, http://links.lww.com/JS9/C697). The baseline demographics and characteristics of the two groups were comparable (Table 1). There were no significant differences in sex (90.7% in the experimental group vs. 92.3% in the control group, P=0.339), age (over 60 years, 54.5 vs. 53.2%, P=0.669), BMI (over 25 kg/m², 37.4 vs. 37.3%, P=0.964), clinical diagnosis (P=0.294), comorbidities, laboratory tests, history of thromboembolism (2.2 vs. 1.3%, P=0.286), and family history of thromboembolism (0.2% in both groups, P=0.905). However, there was a significant difference in the proportion of patients with operating times exceeding 45 min (68.1% in the experimental group vs. 76.4% in the control group, P=0.002), prompting subgroup analyses based on operation duration.

Table 1 Characteristics of included patients.

Characteristics	Experimental (n=508)	Control (n=601)	P	
Demographics (n, %)	
 Age (>60 years)	277 (54.5)	320 (53.2)	0.669	
 Sex (male)	461 (90.7)	555 (92.3)	0.339	
 BMI (>25 kg/m2)	190 (37.4)	224 (37.3)	0.964	
 Smoke	247 (48.6)	257 (42.8)	0.051	
Diagnose (n, %)			0.294	
 Unilateral hernia	348 (68.5)	393 (65.4)		
 Bilateral hernia	145 (28.5)	195 (32.4)		
 Unclassified type hernia	15 (3.0)	13 (2.2)		
Comorbidity (n, %)	
 Hypertension	12 (2.4)	22 (3.7)	0.211	
 Hyperlipidemia	97 (19.1)	85 (14.1)	0.027	
 Diabetes mellitus	11 (2.2)	15 (2.5)	0.717	
 Coronary heart disease	27 (5.3)	31 (5.2)	0.907	
 Varicosity	4 (0.8)	7 (1.2)	0.528	
 Pulmonary disease	3 (0.6)	2 (0.3)	0.524	
 Cancer	2 (0.4)	3 (0.5)	0.793	
Preoperative laboratory tests	
 HGB (g/l)	148.4±15.6	146.8±19.1	0.069	
 PLT (109/l)	211.4±56.0	212.9±62.8	0.198	
 ALT (IU/l)	21.7±20.9	22.2±26.6	0.374	
 AST (IU/l)	23.3±16.3	24.3±21.2	0.134	
 PT (s)	11.4±1.83	11.4±1.65	0.246	
 APTT (s)	31.5±11.0	31.3±17.7	0.708	
 TT (s)	15.8±12.7	16.1±9.7	0.716	
 D-D-dimer (mg/L)	0.29±1.51	0.32±2.19	0.876	
Disease history (n, %)	
 Thromboembolism	11 (2.2)	8 (1.3)	0.286	
Family history (n, %)	
 Thromboembolism	1 (0.2)	1 (0.2)	0.905	
Operation information (n, %)	
 Operation approach, n (%)			0.056	
  Laparoscope	353 (69.5)	385 (64.1)		
  Open	155 (30.5)	216 (35.5)		
Operation time (> 45 min)	346 (68.1)	459 (76.4)	0.002	
ALT, alanine aminotransferase; APTT, activated partial thromboplastin time; AST, aspartate aminotransferase; HGB, hemoglobin; PLT, platelets; PT, prothrombin time; TT, thrombin time.

Bold values indicate statistically significant (P<0.05).

In the experimental group, a simplified VTE risk assessment was used, reducing the time surgeons spent on VTE risk assessment compared to the routine Caprini score assessment (1.39±0.55 min vs. 5.73±1.35 min, P<0.001). Thromboprophylaxis rates were significantly higher in the experimental group compared to the control group for all patients (pharmacologic prophylaxis: 26.2 vs. 6.00%, P<0.001) and particularly for those at high risk of VTE (pharmacologic prophylaxis: 57.3 vs. 9.50%, P<0.001). The risk difference for pharmacologic prophylaxis in high-risk patients was substantial (RD=0.48, 95% CI=0.40–0.56, P<0.01). Additionally, D-dimer levels were significantly lower in the experimental group (0.26±0.73 mg/l) compared to the control group (0.35±0.55 mg/l, P=0.028). However, the incidence of VTE did not differ significantly between the experimental (0.00%) and control groups (0.17%) (RD=0.00, 95% CI=−0.01–0.00, P=0.268) (Fig. 2). Exposure to prophylactic anticoagulation did not increase the risk of bleeding (1.18 vs. 0.67%, P=0.558). The bleeding events were minor, including gingival, nasal, and skin bleeding (Supplemental Table 5, Supplemental Digital Content 2, http://links.lww.com/JS9/C697). There were no significant differences in the net clinical benefit when combining VTE and bleeding events (1.18 vs. 0.83%, P=0.559) (Fig. 2, Supplemental Table 5, Supplemental Digital Content 2, http://links.lww.com/JS9/C697). Subgroup analysis revealed that patients older than 60, with bilateral hernias and operation times >45 min, responded more favorably to the intervention (P for interaction<0.001 for each). The efficacy of the intervention was not significantly influenced by sex (P for interaction=0.61), BMI (P for interaction=0.25), or D-dimer levels (P for interaction=0.98) (Fig. 3).

Figure 2 Outcomes of venous thromboembolism management in patients after hernia surgery.

Figure 3 Subgroup analyses of pharmacological prophylaxis.

Discussion

The CHAT-3 study introduced and clinically validated a simplified three-factor perioperative VTE risk assessment model (including age ≥60 years, history of VTE or family history of VTE/thrombophilia, and operation duration ≥45 min) for IHS. Compared to the Caprini score, which includes 39 risk factors, our streamlined model enables surgeons to identify patients at high risk for VTE more efficiently. As a result, compared to the routine Caprini score: 1) the time surgeons spent on VTE risk assessment was significantly reduced; 2) there was a significant increase in perioperative VTE prophylaxis rate, both among overall patients and those at high risk for VTE; 3) D-dimer levels were significantly lower; 4) exposure to prophylactic anticoagulation did not increase the risk of VTE and bleeding; and 5) there was no difference in the net clinical benefit when combining VTE and bleeding events.

VTE is a leading cause of poor prognosis in surgical patients4 and is mainly preventable15. However, surgeons are generally unaware of the postoperative risks of VTE5, and the complexity of the existing risk assessment tools further decreases their willingness to evaluate VTE risks and implement prophylactic measures. Thus, a VTE risk assessment tool should be both straightforward and user-friendly. Our proposed three-factor model, developed through mathematical analysis and Delphi expert consultation, includes age over 60 years, VTE-related history, and operating duration of 45 min or longer11. Initially, a comprehensive analysis of the data from the CHAT-1 study was conducted to identify related risk factors5. Subsequently, a modified Delphi method was implemented involving 42 experts (the CHAT-3 expert panel) to achieve consensus on this simplified three-factor model. Ultimately, testing of the simplified model demonstrated performance comparable to the Caprini score, but it was more user-friendly. In particular, these three factors are also components of the Caprini score. In the Caprini system, the age categories 41–60, 61–74, and 75 years or older score 1, 2, and 3 points, respectively16. A history of VTE-related problems scores 3 points17,18, and an operation duration ≥45 min or more scores 2 points16. In our trial, patients with two or three risk factors were considered moderate to high risk for VTE, correlated with a Caprini score of 3–9, and advised to receive pharmacological prophylaxis according to current guidelines3,12,13. Therefore, this simple three-factor model is both a validated and an effective means of assessing VTE risk, particularly useful in short hospital stays. With the increasing prevalence of day-case surgeries19 and the highest VTE risk occurring within the first 2 weeks postinguinal hernia repair20, surgeons must quickly assess VTE risk in the hospital and initiate appropriate early postoperative prophylactic measures.

The CHAT-3 study’s findings confirm that surgeons are more inclined to assess patients’ VTE risk using the simple three-factor model instead of the Caprini score, thus improving the prescription of appropriate perioperative VTE prophylaxis. Primarily, the streamlined nature of the three-factor model allows surgeons to quickly gather the necessary information and complete VTE risk assessments in an average of 1.5 min, compared to the nearly 6 minutes required for the Caprini score, which requires extensive patient data collection. This efficiency has significantly enhanced surgeons’ enthusiasm and willingness to use the simplified model. Furthermore, the increased desire to use the three-factor model has positively influenced clinical practice. In particular, thromboprophylaxis rates were substantially higher in the experimental group using the three-factor model than in the control group using the Caprini score among all patients and those at high risk of VTE. However, a higher rate of exposure to prophylactic anticoagulation did not increase the risk of bleeding, and there was no difference in the net clinical benefit when combining VTE and bleeding events.

Patients over 60 years of age and those with operating times exceeding 45 min, identified as needing intensive VTE management, demonstrated better responses to the intervention. This outcome aligns with our anticipated goals, confirming that the simple three-factor model is more effective in targeted VTE management than the Caprini score. This clinical evidence further corroborates the efficacy of the three-factor model.

This study had two limitations. The incidence of VTE was not the primary outcome of this study, as the focus was on testing the effectiveness of the three-factor model, specifically for patients with inguinal hernia, in enhancing the quality of VTE management. A subsequent trial will examine whether VTE management with the three-factor model translates into a reduced incidence of VTE. Furthermore, pharmacological prophylaxis for VTE was not mandatory. Patients identified as high risk for VTE could decline pharmacologic thromboprophylaxis, potentially leading to an underestimation of thromboprophylaxis incidence but reflecting real-world clinical scenarios.

Conclusion

The CHAT-3 trial marks the first instance of testing the simple three-factor model for perioperative VTE management in Chinese patients undergoing IHS. This study has provided high-quality evidence demonstrating that the three-factor model can efficiently identify patients at high risk for VTE and significantly increase the rate of perioperative prophylaxis of VTE. This finding underscores the model’s potential utility in improving patient outcomes by facilitating more effective VTE risk assessment and management in surgical settings.

Ethical approval

Ethical approval has been obtained for this research study. The relevant ethics committee is the Beijing Chaoyang Hospital, Capital Medical University Life Ethics Committee and the reference number for their judgement is No.2020-6-9-1. This information has already been described in the manuscript.

Consent

Ethical approval from a life ethics committee has been obtained for this study and is described in the methodology section. A statement has been added to the end of the manuscript confirming that written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal upon request.

Source of funding

This study was supported by the Academic leader training program of Pudong New Area Health Commission (PWRd2023-02); Talent Project established by Chinese Pharmaceutical Association Hospital Pharmacy Department (CPA-Z05-ZC-2023-003); Research project on sustain improvement of evidence-based medical quality management, National Institute of Hospital Administration, NHC, China (YLZLXZ22K032); Research project on high quality development of Hospital pharmacy, National Institute of Hospital Administration, NHC, China (NIHAYS2305); Beijing Natural Science Foundation (7222071); Beijing Municipal Administration of Hospitals Incubating Program (PG20230303).

Author contribution

Zhi-Chun Gu, Ming-Gang Wang and Yu-Chen Liu are the guarantors of the entire manuscript and contributed to the study conception and design. Yu-Chen Liu, Zi-Chao Zhang, Chang Liu, Ning Ning, Hui Zhang, Nan Zhang and Jian-Wen Li contributed to the data acquisition. Meng-Fei Dai, Meng Hu, Yi-Dan Yan, and Yan Che contributed to the analysis, and interpretation. Zhi-Chun Gu, Meng-Fei Dai and Li Zhang contributed to critical revision of the manuscript for important intellectual content. Hou-Wen Lin contributed to the important guidance for this study. All the authors have read and approved the final version of this manuscript.

Conflicts of interest disclosure

The authors declare that they have no competing interests.

Research registration unique identifying number (UIN)

Our research has been registered with the Chinese Clinical Trial Registry. The hyperlink to the registration is ChiCTR2000033769.

Guarantor

The guarantors for this study are Professor Zhi-Chun Gu, Ming-Gang Wang, and Yu-Chen Liu.

Provenance and peer review

Our paper was not invited. If published, a statement will be included to confirm that the paper is ‘Not commissioned, externally peer-reviewed’.

Data availability statement

The datasets used and/or analyzed during the current study are available from the corresponding authors on reasonable request.

Supplementary Material

Acknowledgements

The authors would like to thank all patients who participated in the present study.

Zhi-Chun Gu, Meng-Fei Dai, Meng Hu, Yi-Dan Yan, and Hou-Wen Lin contributed equally to this work, and should be considered as co–first authors.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal's website, www.lww.com/international-journal-of-surgery.

Published online 4 June 2024
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