INTRODUCTION
As a core procedure in the comprehensive treatment of colorectal cancer (CRC), laparoscopic radical colectomy has markedly reduced surgical trauma by leveraging minimally invasive techniques[1]. However, despite such advancements, postoperative complications including ileus, functional impairment, and diminished quality of life persist, affecting approximately 20% of patients and emerging as a key bottleneck restricting optimal rehabilitation[2]. Thus, how to strengthen the full-cycle perioperative management of CRC patients, reduce postoperative complication rates, and facilitate rapid recovery has become a pressing new challenge for clinical surgeons[3].
Recently, a retrospective cohort study by Yang and Wu[4]. Shed critical light on addressing this challenge through the application of failure mode and effects analysis (FMEA) in CRC perioperative care. Their findings demonstrated that the FMEA nursing model, characterized by systematic proactive risk prediction and targeted personalized interventions, significantly shortens hospital stays, reduces postoperative complication rates, and improves patients’ quality of life. This nursing model not only provides a novel paradigm for CRC perioperative care but also offers profound clinical insights for colorectal surgeons. The individualized therapy for CRC should not be confined to the surgical procedure itself, but rather extended to a full-cycle perioperative risk management system integrated with proactive prediction and intervention for potential complications[5].
Originating from engineering, FMEA is a proactive risk management tool that has emerged as a transformative force in healthcare[6]. Unlike traditional passive management strategies, FMEA conducts systematic failure mode analysis and evaluates the severity, occurrence, and detection of each potential risk, which forms its core working mechanism. FMEA breaks free from the traditional passive “post-hoc remediation” model. It systematically identifies and assesses potential risks throughout the perioperative period, quantifies key risk points, and formulates targeted prevention strategies tailored to patients’ individual characteristics, thus reducing the incidence of adverse events at the source. For example, researchers developed an integrated FMEA with quality indicators model for human papillomavirus genotyping testing, mitigating high-risk failures and improving risk assessment objectivity and diagnostic accuracy[7]. In addition, FMEA-based perioperative management optimizes CRC care, reducing postoperative complications and improving patient prognosis[8]. By systematically identifying potential failure points in clinical processes, evaluating their potential impacts, and implementing targeted preventive interventions, FMEA has been proven effective in reducing medical errors, improving patient safety, and enhancing care quality across various clinical settings[9].
Against the backdrop of the urgent need to optimize postoperative rehabilitation and advance precision medicine, this editorial seeks to explore the practical clinical insights of FMEA-based nursing for colorectal surgeons. We will systematically review and delve into the core dimensions of perioperative treatment of CRC, including nutritional assessment and intervention, individualized customization of surgical plans, as well as prediction and early intervention of postoperative complications. Through this exploration and analysis, we strive to provide colorectal surgeons and care teams with innovative, actionable insights into personalized perioperative management and proactive risk management. This work facilitates the profound transformation of clinical practice from “passive adaptation” to “proactive prediction”, and ultimately improves the overall prognosis and quality of life of patients with CRC.
FMEA MODEL MANAGEMENT IN SURGERY
As a mature proactive risk management tool, FMEA furnishes a scientific framework for individualized perioperative risk control in CRC with an inherent closed-loop logic including process mapping, risk identification, hierarchical intervention and continuous optimization. In clinical practice, individualized proactive risk intervention plays a vital role in decreasing the rate of postoperative complications, facilitating accelerated rehabilitation of patients, and enhancing patient satisfaction[10].
In detail, the surgical team should comprehensively identify all potential failure modes throughout the perioperative period in patients with CRC before surgery (Figure 1). These include preoperative general evaluation, nutritional risk screening and intervention, surgical planning, and postoperative complication monitoring. Subsequently, the severity of harm caused by failure modes (e.g., hypoalbuminemia, anemia, sarcopenia), the occurrence of failure modes (e.g., anastomotic leakage, bleeding, infection), and the detectability of clinical adverse events can be systematically evaluated and scored. Next, the risk priority is evaluated based on these scores, followed by risk stratification. Accordingly, the team formulates targeted preventive and corrective interventions. Following intervention implementation, the team dynamically monitors the occurrence of failure modes, reevaluates the severity, occurrence, and detectability, and adjusts intervention strategies accordingly to achieve closed-loop management.
Figure 1
The colorectal cancer surgery failure mode and effects analysis workflow.
Malnutrition
Nutritional status is a critical factor influencing surgical outcomes, postoperative recovery, and long-term prognosis in patients with CRC[11]. Malnutrition is prevalent in CRC patients due to multiple factors, including tumor cachexia, intestinal obstruction, diarrhea, hematochezia, and anorexia. It is mainly characterized by hypoalbuminemia, anemia, and weight loss, sarcopenia, which directly reduce surgical tolerance and further increase perioperative risks[12].
Specifically, anemia impairs blood oxygen-carrying capacity, thereby increasing the incidence of perioperative adverse events including myocardial ischemia and cerebral hypoxia[13]. Furthermore, anemia induces insufficient perfusion at the intestinal anastomosis, which not only elevates the risk of anastomotic leakage but also delays the recovery of postoperative gastrointestinal function and heightens the incidence of such postoperative complications as intestinal obstruction and gastroparesis[14,15]. The hazards of hypoalbuminemia are equally noteworthy. When hypoalbuminemia is present, plasma colloid osmotic pressure decreases, significantly increasing the risk of ascites and tissue edema during and after surgery, while weakening the body’s stress response to surgical trauma. More critically, edema at the intestinal anastomosis may cause tissue suture laceration and stapler site leakage, delay the healing of surgical incisions and intestinal anastomoses and ultimately further escalate the risk of anastomotic leakage[16]. Thus, how to perform individualized nutritional risk assessment and implement early interventions is a pivotal issue that colorectal surgeons must address.
Nutritional assessment and individualized intervention
The surgical team, as the core coordinators of perioperative management, is expected to play a pivotal role in the nutritional assessment and intervention of patients with CRC. Enlightened by the study of Yang and Wu[4] and the FMEA model, the surgical team should dynamically monitor the patients’ nutritional status, assess nutritional risks, and proactively implement individualized interventions targeting nutritional risks throughout the entire perioperative period.
The Nutritional Risk Screening 2002 (NRS-2002) is the first-line clinical tool and an internationally recognized gold standard for nutritional risk screening. Characterized by its simplicity and efficiency, this scale encompasses three core dimensions: Impaired nutritional status, severity of illness, and age (≥ 70 years). A prospective study enrolled 471 patients with gastrointestinal malignancies and found that 45.01% of them had an NRS-2002 score of ≥ 3 points. The area under the curve for predicting postoperative complications was 0.735, demonstrating that the NRS-2002 can serve as a reliable tool for preoperative nutritional assessment in patients with gastrointestinal malignancies[17]. Additionally, a retrospective study revealed that the overall incidence of postoperative complications was significantly higher in the high-risk group (NRS-2002 score ≥ 3) than in the non-risk group among patients undergoing laparoscopic radical resection[18].
For elderly patients aged ≥ 70 years or those with comorbidities such as diabetes and chronic kidney disease, it is recommended to conduct cross-validation in combination with the Malnutrition Universal Screening Tool (MUST)[19]. This tool assigns scores based on three indicators: Body mass index, magnitude of weight loss, and acute disease stress status. A retrospective study demonstrated that MUST score of ≥ 2 is an independent predictor of postoperative complications in patients with CRC, and recommended that the MUST be incorporated into routine preoperative assessment for CRC[20]. In addition, sarcopenia is an independent risk factor for postoperative complications in CRC patients and thus requires separate assessment[21]. In clinical practice, the diagnosis of sarcopenia is commonly established by measuring skeletal muscle mass via bioelectrical impedance analysis, evaluating psoas muscle area at the level of the third lumbar vertebra using computed tomography imaging, and combining these results with handgrip strength tests[22].
According to FMEA model, individualized nutritional interventions should be implemented for patients preoperatively in accordance with CRC nutritional intervention guidelines and nutritional risk scores[23]. For low-risk patients, the surgical team should guide them to take a balanced, high-protein, high-energy, and easily digestible diet preoperatively. For moderate-risk patients with mild deficiencies (e.g., mild hypoalbuminemia, anemia), dietary guidance combined with oral CRC-specific nutritional supplements is initiated preoperatively. It is advisable to provide appropriate further intervention for mild anemia and hypoalbuminemia preoperatively, so as to reduce the incidence of severe postoperative complications. For high-risk patients, aggressive intervention is needed. Surgery may be considered for appropriate postponement to optimize nutritional status. Intervention mainly includes combined enteral nutrition (EN) and parenteral nutrition (PN) support. In cases of severe anemia, intravenous blood transfusion or iron sucrose may be administered according to clinical indications. For severe hypoalbuminemia, short-term albumin infusion can be considered in combination with nutritional support. Sarcopenia may be managed with resistance training combined with branched-chain amino acid supplementation.
Two pitfalls should be avoided in postoperative intervention: First, over-reliance on PN. EN should be initiated promptly after gastrointestinal function recovery (post-flatus); even with insufficient intake, combined PN protects the intestinal mucosal barrier[24]. Second, neglecting dynamic indicator changes. Regular nutritional assessments and regimen adjustments are required to prevent persistent nutritional issues from rigid plans[25]. In diabetic patients, blood glucose should be closely monitored during intervention to avoid severe complications caused by drastic blood glucose fluctuations[26].
Individualized customization of surgical plans
Guided by the FMEA concept, the individualized customization of surgical plans for CRC patients focuses on proactively identifying and intervening in potential surgical risks, rather than passively addressing postoperative complications post-occurrence. As the core of perioperative management, surgeons should integrate proactive risk intervention and targeted prevention into the entire process of surgical plan formulation, optimizing surgical safety through scientific planning and ultimately improving patients’ long-term prognosis.
Preoperatively, the surgical team shall integrate clinical data, imaging findings and evidence-based guidelines for CRC to identify potential intraoperative and postoperative surgical risks, including anastomotic leakage, intraoperative bleeding, intestinal obstruction and pelvic autonomic nerve injury. For elderly patients or those with comorbidities such as hypertension, coronary heart disease and coagulation disorders who have a high preoperative risk of anastomotic leakage (e.g., low rectal cancer, preoperative malnutrition, a history of pelvic surgery or tumor infiltration of the intestinal wall), Hartmann’s procedure may be considered a preferred option to reduce anastomosis-related risks and improve surgical safety. For patients in generally good clinical condition but with a high risk of anastomotic leakage, surgeons may perform a protective ileostomy to reduce anastomotic tension and the risk of intestinal content contamination. In addition, surgeons can complete three-dimensional reconstruction of mesenteric blood vessels based on preoperative imaging of patients to preserve key blood vessels intraoperatively and enhance blood supply to the anastomosis[27]. Meanwhile, intraoperative indocyanine green angiography is used to assess intestinal blood perfusion, which ensures adequate blood supply to the anastomosis and further reduces the risk of leakage[28]. For centers without intraoperative navigation, careful preoperative imaging review can help avoid severe complications from vascular or anatomical variations. For patients with locally advanced CRC or suspected pelvic autonomic nerve invasion, the formulation of surgical plans shall balance radical tumor resection and organ function protection[29]. Surgeons may accurately evaluate the anatomical relationship between the tumor and pelvic autonomic nerves via preoperative pelvic magnetic resonance imaging. Intraoperatively, unnecessary nerve injury should be minimized to reduce the risk of postoperative complications that may severely affect quality of life, including urinary incontinence and sexual dysfunction. Additionally, the necessity of neoadjuvant therapy or total neoadjuvant therapy for tumor downstaging should be comprehensively evaluated, which serves as a pivotal strategy for critical organ preservation and pelvic autonomic nerve sparing in locally advanced CRC[30,31].
Prediction and early intervention of postoperative complications
The surgical team should proactively predict and implement early intervention for postoperative complications in patients with CRC, abandoning the traditional model of passive treatment after complications manifest. Clinicians can predict postoperative complications based on relevant clinical and imaging indicators. For instance, anastomotic leakage, the most vexing complication for colorectal surgeons, necessitates postoperative monitoring of vital signs, objective laboratory parameters and imaging examinations (e.g., computed tomography)[32,33]. Key monitoring items include C-reactive protein, procalcitonin, white blood cell count, albumin levels, and the character of drainage fluid from indwelling drainage tubes. If a patient is assessed to be at high risk of anastomotic leakage, proactive interventions may be considered, including appropriate empirical antibiotic use, adoption of a residue-free diet, intensification of nutritional support, and continuous irrigation via a double-lumen drainage tube to ameliorate local infection.
Postoperative bleeding, another common high-risk complication, requires monitoring of vital signs (blood pressure, heart rate, hemoglobin), abdominal drainage and stool characteristics. Persistent hypotension, tachycardia, rapid hemoglobin drop, or bright red drainage signal active bleeding, mostly from inadequate hemostasis or anastomotic bleeding. High-risk patients should receive proactive prophylaxis, including close hemodynamic monitoring, assessment of the need for hemostatic agents according to clinical conditions, and avoidance of excessive anticoagulation.
For patients at high risk of intestinal obstruction (e.g., preoperative adhesions, extensive intestinal manipulation), intestinal loops are carefully positioned in a physiologically anatomical orientation intraoperatively to prevent torsion, compression and adhesion formation[34]. In addition, early mobilization (ambulation within 24-48 hours postoperatively) and EN should be initiated to promote intestinal peristalsis[35]. Dynamic monitoring of abdominal distension, bowel sounds, and defecation is performed, and decompression plus prokinetic agents are administered for delayed gastrointestinal function to prevent complete intestinal obstruction. For infections, standardize perioperative antibiotic prophylaxis, keep incisions/drains clean, monitor body temperature and inflammatory markers. For patients with suspected anastomotic leakage or infection, bacterial culture and drug susceptibility testing should be performed at an early stage to facilitate subsequent targeted anti-infective therapy and prevent the spread of infection as well as the development of severe systemic inflammatory response syndrome[36].
DISCUSSION
Laparoscopic radical colectomy and proctectomy constitutes the cornerstone of surgical treatment for CRC. However, postoperative complications not only inflict severe suffering on patients but also pose formidable clinical challenges for surgeons. The research findings by Yang and Wu[4] and the FMEA model offer valuable insights for clinical practice: The implementation of individualized and proactive management and intervention for complication risks in CRC patients is practically feasible and effective in clinical work. This editorial systematically expounds on the application of FMEA based individualized proactive risk management in CRC perioperative period, focusing on three core dimensions: Nutritional assessment and intervention, individualized surgical plan customization, and postoperative complication prediction and early intervention.
FMEA redefines the connotation of CRC individualized therapy, expanding it from a single surgical procedure to a full-cycle perioperative risk management system covering the preoperative, intraoperative and postoperative stages. Malnutrition, an independent risk factor for severe complications such as anastomotic leakage. We could conduct nutritional risk assessment for CRC patients using scales including the NRS-2002 and MUST in combination with sarcopenia evaluation, then implemented stratified management and nutritional intervention to analyze whether this approach could achieve the objective of reducing the incidence of postoperative complications. Although several relevant studies have been published to date, most are retrospective risk analysis studies, and further high-quality prospective, multicenter investigations are urgently needed[37].
FMEA-guided individualized surgical plan customization translates preoperative risk prediction into concrete and targeted surgical decisions, forming the core link of intraoperative risk control. For patients at high risk of anastomotic leakage, the selective application of Hartmann’s procedure or protective ileostomy, combined with mesenteric vessel three-dimensional reconstruction and indocyanine green angiography, effectively ensures adequate anastomotic blood supply and fundamentally reduces leakage risk. For patients with locally advanced CRC, the selection of neoadjuvant therapy or total neoadjuvant therapy preoperatively is also of vital importance. Preoperative assessment of organ preservation and nerve protection should be performed in conjunction with imaging findings and digital rectal examination, which is crucial for improving patients’ long-term quality of life.
Based on FMEA’s hierarchical monitoring logic, the prediction and early intervention of postoperative complications is a critical measure to block the progression of adverse clinical events. For core complications including anastomotic leakage, postoperative bleeding, intestinal obstruction and infectious complications, a multi-dimensional monitoring system combining clinical symptoms, laboratory parameters and imaging indicators enables the early identification of high-risk warning signals. More importantly, implementing proactive targeted interventions before the onset of typical complication symptoms. For patients at high risk of anastomotic leakage, antibiotic escalation and double-lumen drainage irrigation may be considered based on actual clinical conditions. For postoperative bleeding, graded hemostatic intervention can be adopted according to the severity of bleeding and patient-specific conditions; for patients at high risk of intestinal obstruction. Early mobilization and exercise are recommended as appropriate; and for infectious complications, standardized antibiotic prophylaxis should be implemented in light of clinical manifestations and laboratory indicators. These proactive interventions may help reduce the severity of complications and the reoperation rate in clinical practice. To date, clinical research on the proactive intervention of postoperative complications remains relatively scarce, and we will conduct and complete relevant research and practical work in this field in the subsequent stage.
The effective implementation of FMEA-based perioperative risk management in CRC is inherently dependent on multidisciplinary team collaboration. Surgeons, nutritionists, radiologists, anesthesiologists and nurses each undertake core responsibilities in different links: Nutritional assessment and intervention, imaging support for risk prediction and surgical planning, intraoperative precise operation, and postoperative dynamic monitoring and early warning. A surgeon-led multidisciplinary team enables the integration of multidimensional clinical data, ensures the continuity and accuracy of perioperative risk management, and serves as an indispensable guarantee for the clinical implementation of the FMEA model.
This editorial has certain limitations. First, our perspectives and conclusions rely mainly on colorectal surgeons’ clinical experience, which may limit the research perspective and introduce potential bias. Because we may overfocus on surgical-related aspects while underestimating the comprehensive impact of other clinical disciplines on perioperative risk management. Second, our viewpoints lack sufficient support from prospective, multi-center, large-sample clinical studies. Most cited studies are retrospective analyses or single-center experiences, which have limitations in evidence level and generalizability, making it hard to fully verify the long-term effectiveness and wide applicability of FMEA-based individualized proactive risk management. To address these limitations, we will conduct in-depth prospective studies focusing on the prediction and proactive intervention of CRC surgery-related complications, systematically evaluate the effects of individualized proactive strategies, and verify their feasibility, safety and effectiveness in reducing postoperative complications and improving patient prognosis. We aim to provide high-quality clinical evidence for the popularization of the FMEA model in the perioperative management of CRC through these research efforts.
