Introduction
Cervical cancer is the fourth most common malignancy. It ranks fourth as the cause of death among women worldwide [
1]. Surgery remains the cornerstone of early stage cervical cancer treatment [
2]. Surgical outcomes, including adverse events (i.e., intra-, and post-operative complications), reflect surgical quality. Adverse events may, in turn, have an impact on survival outcomes [
3,
4]. With an increase in surgical volume and the complexity of preoperative comorbidities, concerns regarding surgical adverse events have been continuously rising. Ongoing efforts have been made to standardize quality assessments and to promote quality improvement in cervical surgery.
In 2004, a classification system for postoperative complications (the Clavien–Dindo classification) was published [
5]. This classification has been validated worldwide and has become a benchmark for reporting postoperative complications within and across researchers and institutions [
6‐
8]. However, this system was not designed to assess intraoperative complications. Moreover, nearly half of surgical trials fail to report intraoperative complications because of the absence of a robust grading system [
9]. Hence, the CLASSification of Intraoperative Complications (ClassIntra version 1.0) was constructed to grade intraoperative adverse events (iAE) by Dell-Kuster and colleagues [
10]. This classification system evaluates any surgical or anesthetic iAE occurring between skin incision and closure, and can be incorporated into perioperative surgical safety checklists. A recent international study has demonstrated that an increasing grade of the most severe iAE was closely related to a more severe postoperative complication across various surgical fields [
11]. However, this study included large amounts of patients who underwent gastrointestinal surgery (57%), while less than 2% of the patients underwent gynecological surgery. For the broader application of ClassIntra grade, further validations in the field of gynecology are warranted.
Since 1993, laparoscopic radical hysterectomies have been considered an alternative to open radical hysterectomies in patients with early stage cervical cancer [
12]. However, the risk of intra- or post-operative complications may increase with this approach, owing to technical difficulties [
3,
13,
14]. Uniform definitions of surgical adverse events are required to improve the safety evaluation of novel surgical techniques. Moreover, the introduction of surgical quality metrics is required for surgeons to overcome the early phase of the learning curve, for patients, and to reduce postoperative morbidity and mortality.
In this study, we analyzed the validity of the ClassIntra grade in patient who underwent laparoscopic radical hysterectomy for early stage cervical cancer and investigated the associations between iAE and surgical outcomes based on a prospective cohort. We also aimed to establish a reference for the application of laparoscopic radical hysterectomy in the treatment of cervical cancer.
Discussion
Surgical outcomes show a close correlation with the quality of intraoperative performance. In this study, we found that the incidence of iAE was significantly associated with perioperative outcomes. Patient-reported outcomes, including satisfaction and QOL, were significantly worse in the presence of iAE. To the best of our knowledge, this is the first study to verify the ClassIntra classification system for the evaluation of the quality of laparoscopic radical hysterectomies. This system may be a reliable tool to evaluate intraoperative surgical performance and guide postoperative care.
Surgery remains the cornerstone of the management of patients with early stage cervical cancer. Ensuring patient safety during the perioperative course has, therefore, been a topic of concern for surgeons [
18,
19]. Given the close relationship between surgical performance and outcome, a robust grading tool is needed to evaluate surgeons’ performance in improving patients’ outcomes [
20,
21]. The ClassIntra system is a standardized and comprehensive tool for assessing iAE across different surgical disciplines [
10]. Unlike other classification systems [
22‐
24], it has been validated on an international prospective cohort, based on a large sample size [
11]. This system was used to identify and grade iAE during laparoscopic radical hysterectomies. The overall incidence of iAE was 24.6% in this study, which is similar to that reported by Liu (20%) [
25] but lower than that reported by Dell-Kuster (37%) [
11]. This difference may be explained by that all surgeries were performed by an experienced surgeon. Moreover, the incidence of iAE was higher than the rates of intraoperative complications reported by several randomized controlled trials [
26], which could be explained by consideration regarding anesthesia events and our strict assessment.
Previous studies have attempted to address classification systems for iAE. For example, Francis et al. developed an EAES classification to evaluate iAE in laparoscopic surgery [
24]. This classification also contained five grades but excluded anaesthesia-related adverse events. Kaafarani et al. proposed a 6-point severity classification system and demonstrated a significant association between severe iAE and postoperative complications [
23]. However, this system was only analyzed in patients with accidental trauma. Unlike other systems, the ClassIntra classification system is the first comprehensive system that has been prospectively validated in an international, multicenter cohort involving any type of surgery [
11]. Therefore, we adopted this classification system to assess iAE during laparoscopic radical hysterectomy due to its good generalizability.
It was found that the incidence of iAE was significantly associated with an increased risk of postoperative complications and prolonged hospital stay, as is consistent with the results of previous studies [
10,
11,
25]. With the increasing application of innovative surgical techniques, decreasing intra- and post-operative adverse events has become even more important. In this regard, the ClassIntra grading system should be incorporated into routine practice so as to foreground patients with iAE and prevent further postoperative complications. Moreover, the OSATS score, which was designed to evaluate intraoperative technical performance, was closely related to postoperative complications. Although this score lost its independent value after adjusting for iAE, it was independently associated with the incidence of iAE, which was in line with previous findings [
25]. The OSATS may assist in guiding surgical training and quality improvement interventions for less-experienced surgeons.
Regular collection of patient-reported outcomes can help improve patient-clinician communication, patient satisfaction, QOL, and overall survival [
27,
28]. Given the negative impact of iAE on patient satisfaction and QOL, clinicians should enhance their medical monitoring of these “high-risk” patients during their hospitalizations and after discharge. Further research is required to address this issue.
Our study has several strengths. As the first study validating the efficacy of the ClassIntra classification system in the field of gynecological oncology, a prospective cohort was analyzed to reduce potential bias and improve the reliability. Additionally, this study was not only conducted to investigate the association between iAE and postoperative morbidity, but also explored the long-term impact of iAE on patient outcomes, thereby highlighting the need for individualized treatment and surveillance strategies in patients who experienced iAE.
This study has certain limitations. First, although all the data were derived from a prospective cohort, the study design was retrospective and selection bias was inevitable. Second, all patients were treated at a single institution in China, which may limit the generalizability of our findings. Finally, the ClassIntra grade was developed for all surgical disciplines and not specifically for cervical cancer surgery; therefore, specific items regarding this specialty should be included in the grading process.
In conclusion, iAE identified by the ClassIntra grade were significantly associated with postoperative complications and recovery as well as with patient satisfaction and QOL. This grade should be routinely applied in surgical quality control and clinical decision making, particularly in future clinical trials. For the broader application of ClassIntra grade in the field of gynecologic oncology, further studies will be performed in patients with other gynecologic malignancies.
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