Failure mode and effects analysis nursing model improves recovery and quality of life post-laparoscopic extended radical colectomy for colorectal cancer

Abstract

BACKGROUND

Postoperative gastrointestinal recovery is a critical factor influencing patient rehabilitation.

AIM

To investigate the effects of conventional care compared with the failure mode and effects analysis (FMEA) protocol on postoperative recovery in patients undergoing surgery.

METHODS

A retrospective cohort study analyzed 225 patients with colorectal cancer (conventional care group: n = 122; FMEA group: n = 103) treated between June 2021 and June 2024. Outcomes included gastrointestinal recovery (time to flatus/bowel movement and diet tolerance), functional capacity (6-minute walk distance test and sit-to-stand test), complications, quality of life (General Comfort Questionnaire, Barthel index, and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30), and satisfaction.

RESULTS

The FMEA group demonstrated significantly accelerated recovery: Shorter hospital stays (4.49 ± 0.38 days vs 4.66 ± 0.42 days, P = 0.002), earlier flatus (18.58 ± 1.86 hours vs 19.09 ± 1.93 hours, P = 0.045), and improved 6-minute walk distance at 8 weeks (526.16 ± 88.71 m vs 495.29 ± 94.82 m, P = 0.013). Complication rates decreased (nausea/vomiting: 12.62% vs 22.95%, P = 0.046; bowel obstruction: 2.91% vs 10.66%, P = 0.024). Quality of life metrics significantly favored FMEA: Total comfort score (91.66 ± 4.71 vs 89.27 ± 4.87, P < 0.001), Barthel index (67.93 ± 3.19 vs 66.71 ± 3.35, P = 0.006), and higher “very satisfied” rates (61.17% vs 47.54%, P = 0.041).

CONCLUSION

FMEA-based nursing significantly enhances postoperative functional recovery, reduces complications, and improves quality of life in patients undergoing extended colectomy.

Key Words: Failure mode and effects analysis; Postoperative recovery; Functional recovery; Gastrointestinal function; Postoperative quality of life; Nursing intervention

Core Tip: This study introduces the failure mode and effects analysis nursing model into the postoperative care of patients undergoing laparoscopic extended colectomy for colorectal cancer. By systematically identifying and proactively mitigating potential risks throughout the perioperative pathway, this innovative approach was found to significantly accelerate gastrointestinal and functional recovery, reduce specific complications, and enhance overall quality of life, demonstrating superior efficacy compared to conventional care protocols.

INTRODUCTION

Colorectal cancer (CRC) is a leading cause of cancer-related mortality globally, characterized by malignant proliferation in the colon/rectum[1,2]. Clinical manifestations include altered bowel habits, hematochezia, and weight loss[3]. Pathogenesis involves cumulative genetic mutations driving uncontrolled epithelial cell growth[4]. Laparoscopic extended radical colectomy, a minimally invasive technique, has become standard for locally advanced CRC due to reduced trauma and faster recovery than open surgery[5,6]. However, postoperative ileus, functional impairment, and diminished quality of life persist despite advancements, affecting 20%-30% of patients[7].

Postoperative gastrointestinal dysfunction is a common complication following surgical procedures, leading to prolonged hospital stays and increased morbidity[8]. Advances in perioperative care have introduced various protocols aimed at optimizing recovery. The current enhanced recovery after surgery (ERAS) protocols prioritizes early mobilization and multimodal analgesia but lack systematic risk mitigation for nursing-related failures[9]. These protocols often focus on standardized pathways without addressing specific risks and vulnerabilities unique to individual patients or clinical settings.

Failure mode and effects analysis (FMEA) is a proactive method used to identify potential failures in processes, assess their impact, and implement preventive measures. Originally developed in engineering, FMEA has been adapted for use in healthcare to enhance patient safety and improve clinical outcomes[10]. In the context of surgical care, FMEA can be applied to identify and mitigate risks throughout the perioperative period, from preoperative assessment to postoperative recovery. The FMEA care protocol integrates FMEA principles into nursing and medical care, aiming to systematically identify potential failure points in the care process and implement targeted interventions to address them. This approach ensures that each step in the patient’s journey is optimized for safety and efficacy, thereby improving overall recovery outcomes.

Previous studies have shown that FMEA-based interventions can lead to significant improvements in patient safety and care quality[11]. For example, FMEA has been successfully used to reduce medication errors, improve handover processes, and enhance compliance with best practices[12]. However, evidence on the application of FMEA in the context of postoperative recovery is limited, particularly in comparison with conventional care (CC) protocols. This study aims to evaluate the impact of the FMEA protocol on postoperative recovery, focusing on gastrointestinal function, exercise recovery, and quality of life. By integrating detailed risk assessments and targeted interventions, this protocol seeks to provide a more personalized and effective approach to patient care. The primary objective is to demonstrate improved recovery outcomes and patient satisfaction, thereby setting a new standard for postoperative care.

MATERIALS AND METHODS

Research design

This study selected 225 patients who underwent laparoscopic extended colectomy for CRC at Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from June 2021 to June 2024 as research subjects. All patients met the inclusion criteria. Patients were divided into two groups based on the care model received after admission: The CC group and the FMEA group. Among them, 122 patients received CC, while 103 patients received care interventions based on FMEA.

Ethical considerations

This research was approved by Ethics Committee of Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Since the study involved the use of anonymized patient data and posed no potential risks or negative impacts on patient care, the requirement for informed consent was waived for this retrospective analysis. This exemption was granted by Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College’s Ethics Committee in compliance with relevant regulatory and ethical standards.

Inclusion and exclusion criteria

Inclusion criteria: (1) Diagnosed with CRC and underwent laparoscopic extended colectomy for CRC[13]; (2) Aged between 18 years and 75 years; (3) No severe cardiopulmonary insufficiency or other systemic diseases (such as severe diabetes or liver or kidney failure); and (4) Complete data.

Exclusion criteria: (1) Extensive metastasis or advanced cancer; (2) Severe cardiopulmonary insufficiency that cannot tolerate general anesthesia; (3) Extensive intra-abdominal adhesions or other conditions unsuitable for laparoscopic procedures; (4) Other malignancies within the past 5 years; (5) Severe mental or cognitive impairments that prevent understanding of the study content or cooperation in follow-up and evaluation; (6) Underwent other major surgeries within the past 6 months; and (7) Incomplete data.

Grouping criteria

The CC group received routine clinical care protocols from the time of patient admission. This model focuses on reactive management of issues that have already arisen, centered around the execution of established clinical pathways. These care measures included, but were not limited to, routine preoperative assessments, surgical preparations, postoperative care, and follow-up after discharge. Healthcare providers followed the hospital’s existing standard operating procedures. All care activities were documented in the patients’ electronic medical record system to ensure data integrity and traceability.

The FMEA group received a structured, prospective care protocol built on the FMEA model. The core purpose of applying the FMEA model in this study was to systematically identify and anticipate potential nursing weaknesses and risk factors throughout the entire perioperative process, thereby implementing targeted preventive interventions aimed at fundamentally reducing complications, accelerating functional recovery, and improving patients’ quality of life. A multidisciplinary team was formed before the implementation of the protocol to achieve this goal. The team systematically mapped out the entire care pathway from admission to discharge and conducted prospective risk analyses for each step (such as preoperative psychological counseling, pain management strategies, and early mobilization). They identified “what could go wrong” (failure modes), analyzed “the causes and consequences of these failures” (effect analysis), and accordingly developed and integrated specific optimization measures into the care plan. This approach fundamentally differs from traditional care due to its proactive prevention and high degree of personalization. For example, while traditional care provides analgesics when a patient complains of pain, the FMEA model preemptively assesses the risk that patients may avoid coughing or getting out of bed due to fear of pain, thus developing and strictly enforcing a preventive analgesia plan on the basis of non-pharmacological measures and scheduled medication. Nurses actively assist and supervise patients in early mobilization. Therefore, FMEA care is not simply a collection of isolated measures but a systematic, continuous quality improvement model that integrates risk warnings and proactive interventions throughout the entire care process.

Baseline data and demographic information

Baseline data and demographic information were obtained from the medical record system. Demographic information, such as gender, age, and body mass index, was retrieved for each patient. Baseline data, including tumor staging assessed using the tumor-node-metastasis staging system, were extracted from the medical records[14]. Information regarding the surgical procedure and its location were obtained from the surgical reports.

Functional recovery

Functional recovery data were systematically collected from the hospital’s electronic medical record system. Parameters, such as surgical duration, hospital stay duration, time to first flatus, time to first bowel movement, and time to initiation of food intake, were retrieved to assess the recovery of gastrointestinal function in patients. Additionally, the time to resumption of normal activity was documented. The patients were evaluated using two standardized functional tests: The 6-minute walk distance (6MWD) test and the sit-to-stand test. These assessments were conducted at postoperative weeks 4 and weeks 8.

The 6MWD test was conducted in accordance with the protocol published by the American Thoracic Society to evaluate functional capacity[15]. The 6MWD test is a submaximal exercise endurance test widely used to assess functional exercise capacity in individuals with cardiopulmonary diseases, post-surgical patients, and elderly populations. Its primary purpose is to evaluate an individual’s overall exercise endurance and functional status over a specific period, with results highly correlated with the ability to perform activities of daily living (ADL). The test is conducted on a quiet, flat corridor that is 30 m long. Before the test, patients are informed that the goal is to “walk as far as possible within 6 minutes” and that they can adjust their speed or rest in accordance with their fatigue level. At the end of the 6 minutes, the total walking distance is recorded in meters. A longer distance indicates better cardiopulmonary function and exercise endurance.

The sit-to-stand test is a simple and effective tool used to assess lower limb muscle strength, endurance, and functional activity capacity, particularly suitable for elderly and postoperative patients[16]. This test effectively reflects the patient’s ability to perform daily activities such as transitioning from sitting to standing. During the test, the patient sits on a chair without armrests, with a height of approximately 43 cm, maintaining an upright back and feet flat on the floor. Upon hearing the “start” command, the patient completes as many full cycles as possible of moving from a seated position to a fully standing position and then returning to a seated position within 60 seconds. The number of complete cycles performed within 60 seconds is recorded. A higher number of repetitions indicates better lower limb function and dynamic balance ability.

Quality of life

Quality of life was assessed at 4 weeks postoperatively. The General Comfort Questionnaire by Kolcaba[17] was used to evaluate patient comfort, encompassing four domains: Physical comfort (six items), psychological comfort (six items), environmental comfort (six items), and social comfort (five items). Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree), with total scores ranging from 23 to 115. A total score below 60 indicates significant discomfort, a score between 60 and 90 suggests mild discomfort, and a score above 90 indicates high comfort.

The Barthel index was employed to assess individuals’ ADL by using a quantitative scoring system[18]. It evaluates 10 domains: Eating, bathing, grooming, dressing, bowel control, bladder control, toileting, transferring from bed to chair, walking on a level surface, and climbing stairs. Scores for each domain range from 0 (complete dependence) to the highest score for independent completion, with a total score ranging from 0 to 100. The total score reflects the patient’s self-care ability level, where higher scores indicate greater independence and lower scores indicate a greater need for assistance and support. Scores between 21 and 40, 41 and 60, 61 and 90, and 91 and above indicate severe dependence, moderate dependence, mild dependence, and full independence, respectively.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 questionnaire was used to assess quality of life, focusing on functional scales and symptom scales[19]. This questionnaire includes five functional scales (physical, role, emotional, cognitive, and social functioning), and three symptom scales (fatigue, nausea and vomiting, and pain). The functional scales consist of 14 items, with each question scored from 1 (not at all) to 4 (very much), where higher scores are better. The symptom scales include six items, each rated from 1 (not at all) to 4 (very much), where higher scores indicate less severe symptoms and impact on quality of life.

Patient satisfaction

Patient satisfaction was assessed using the Service Quality Questionnaire, which encompasses five dimensions: Tangibles, reliability, responsiveness, assurance, and empathy[20]. Each dimension is rated on a scale from 1 (very poor) to 7 (very good). A total score above 30 indicates very satisfied patients, scores between 15 and 30 indicate basically satisfied patients, and scores below 15 indicate dissatisfied patients.

Statistical analysis

This study had no missing data. Data analysis was performed using SPSS (version 29.0) statistical software (SPSS Inc., Chicago, IL, United States). Categorical variables were expressed as n (%) and analyzed using χ² tests and basic formulas. Continuous variables were tested for normal distribution by using the Shapiro-Wilk method. For continuous variables that followed a normal distribution, they were reported as mean ± SD and analyzed using t-tests adjusted for variance. A two-tailed P < 0.05 was considered statistically significant.

RESULTS

Baseline data and demographic information

In comparing the baseline data and demographic information between the CC group (n = 122) and the FMEA group (n = 103), no significant differences were observed across all indicators (Table 1). Specifically, no significant differences were found in age (47.82 ± 3.74 vs 48.29 ± 3.58, P = 0.344), gender distribution (female: 26.23% vs 28.16%, male: 73.77% vs 71.84%, P = 0.746), body mass index (22.18 ± 2.21 vs 22.23 ± 2.13, P = 0.864), smoking history (40.16% vs 37.86%, P = 0.725), alcohol history (45.9% vs 45.63%, P = 0.968), educational attainment (P = 0.919), residence location (urban: 68.03% vs 65.05%, rural: 31.97% vs 34.95%, P = 0.636), tumor-node-metastasis tumor stage (P = 0.977), resection site (P = 0.883), extent of resection (P = 0.962), hypertension prevalence (22.13% vs 27.18%, P = 0.380), cardiovascular disease (9.84% vs 10.68%, P = 0.835), diabetes mellitus (10.66% vs 13.59%, P = 0.499), hemoglobin level (13.17 ± 1.76 vs 13.33 ± 1.85, P = 0.522), and blood glucose level (96.34 ± 6.53 vs 95.47 ± 6.18, P = 0.309).

Table 1 Baseline data and demographic information, mean ± SD/n (%).

Indicator	CC group (n = 122)	FMEA group (n = 103)	t/χ2	P value
Age	47.82 ± 3.74	48.29 ± 3.58	0.947	0.344
Gender			0.105	0.746
Female	32 (26.23)	29 (28.16)
Male	90 (73.77)	74 (71.84)
BMI	22.18 ± 2.21	22.23 ± 2.13	0.171	0.864
Smoking history	49 (40.16)	39 (37.86)	0.124	0.725
Alcohol history	56 (45.9)	47 (45.63)	0.002	0.968
Educational attainment			0.169	0.919
Elementary school and below	27 (22.13)	25 (24.27)
Middle school	62 (50.82)	50 (48.54)
University and above	33 (27.05)	28 (27.18)
Residence location			0.224	0.636
Urban	83 (68.03)	67 (65.05)
Rural	39 (31.97)	36 (34.95)
TNM tumor stage			0.047	0.977
I	45 (36.89)	37 (35.92)
II	41 (33.61)	36 (34.95)
III	36 (29.51)	30 (29.13)
Resection site			0.249	0.883
Right hemicolectomy	63 (51.64)	55 (53.40)
Left hemicolectomy	37 (30.33)	32 (31.07)
Sigmoidectomy	22 (18.03)	16 (15.53)
Extent of resection			0.002	0.962
Standard radical resection	98 (80.33)	83 (80.58)
Extended radical resection	24 (19.67)	20 (19.42)
Hypertension	27 (22.13)	28 (27.18)	0.772	0.380
Cardiovascular disease	12 (9.84)	11 (10.68)	0.043	0.835
Diabetes mellitus	13 (10.66)	14 (13.59)	0.456	0.499
Hemoglobin level	13.17 ± 1.76	13.33 ± 1.85	0.641	0.522
Blood glucose level	96.34 ± 6.53	95.47 ± 6.18	1.019	0.309

BMI: Body mass index; TNM: Tumor-node-metastasis; CC: Conventional care; FMEA: Failure mode and effects analysis.

Postoperative recovery

Several significant differences were observed upon comparing postoperative gastrointestinal function recovery between the CC group and the FMEA group (Table 2). Surgical duration did not differ significantly between the two groups, with the CC and FMEA groups having mean durations of 149.67 ± 15.23 minutes and 147.49 ± 13.77 minutes, respectively (P = 0.265). However, notable differences were found in other key indicators. The length of hospital stay was significantly shorter in the FMEA group than in the CC group (4.49 ± 0.38 days vs 4.66 ± 0.42 days, P = 0.002). The time to first flatus was significantly shorter in the FMEA group (18.58 ± 1.86 hours vs 19.09 ± 1.93 hours, P = 0.045). Similarly, the time to first bowel movement was shorter in the FMEA group (48.16 ± 3.68 hours vs 49.35 ± 3.84 hours, P = 0.019). Additionally, the FMEA group tolerated a liquid diet sooner than the CC group (1.75 ± 0.35 days vs 1.86 ± 0.37 days, P = 0.030) and reached tolerance for solid diets more quickly (3.78 ± 0.41 days vs 3.95 ± 0.46 days, P = 0.004). The time to recovery of bowel sounds was significantly shorter in the FMEA group (23.93 ± 2.66 hours vs 25.07 ± 2.78 hours, P = 0.002).

Table 2 Postoperative gastrointestinal function recovery, mean ± SD.

Indicator	CC group (n = 122)	FMEA group (n = 103)	t	P value
Surgical duration (mins)	149.67 ± 15.23	147.49 ± 13.77	1.118	0.265
Length of hospital stay (days)	4.66 ± 0.42	4.49 ± 0.38	3.202	0.002
Time to first flatus (hours)	19.09 ± 1.93	18.58 ± 1.86	2.014	0.045
Time to first bowel movement (hours)	49.35 ± 3.84	48.16 ± 3.68	2.369	0.019
Time to liquid diet tolerance (days)	1.86 ± 0.37	1.75 ± 0.35	2.178	0.030
Time to solid diet tolerance (days)	3.95 ± 0.46	3.78 ± 0.41	2.913	0.004
Time to bowel sound recovery (hours)	25.07 ± 2.78	23.93 ± 2.66	3.120	0.002

CC: Conventional care; FMEA: Failure mode and effects analysis.

In evaluating postoperative exercise recovery between the CC group and the FMEA group, significant differences were observed in several key indicators (Figure 1). The time to resume normal activities was slightly shorter in the FMEA group than in the CC group (2.63 ± 0.31 days vs 2.73 ± 0.38 days, P = 0.023). At 4 weeks post-operation, the 6MWD was significantly greater in the FMEA group (480.12 ± 111.9 m) than in the CC group (446.72 ± 105.12 m, P = 0.022). This trend continued at 8 weeks, with the FMEA group again showing a higher 6MWD (526.16 ± 88.71 m vs 495.29 ± 94.82 m, P = 0.013). The sit-to-stand test performance favored the FMEA group. At 4 weeks, the FMEA group demonstrated better results (14.72 ± 2.59 repetitions) than the CC group (13.83 ± 2.72 repetitions, P = 0.013). Similarly, at 8 weeks, the FMEA group showed improved performance (18.58 ± 2.90 repetitions vs 17.69 ± 3.12 repetitions, P = 0.029).

Figure 1 Postoperative exercise recovery. A: Time to resume activities (days); B: 6-minute walk distance at week 4 (m); C: 6-minute walk distance at week 8 (m); D: Sit-to-stand test at week 4; E: Sit-to-stand test at week 8. CC: Conventional care; FMEA: Failure mode and effects analysis; 6MWD: 6-minute walk distance.

The postoperative complication occurrence between the CC group and the FMEA group showed several significant differences (Figure 2). For infections, no significant difference was found between the two groups, with rates of 5.74% in the CC group and 1.94% in the FMEA group (P = 0.269). Similarly, fever incidence was comparable, with 13.11% in the CC group and 12.62% in the FMEA group (P = 0.912). However, notable differences were found in other complications. The incidence of nausea and vomiting was significantly lower in the FMEA group than in the CC group (12.62% vs 22.95%, P = 0.046). Additionally, bowel obstruction occurred less frequently in the FMEA group (2.91% vs 10.66%, P = 0.024). Abdominal distension was less common in the FMEA group (19.42% vs 31.15%, P = 0.045). No significant difference was observed in the rate of anastomotic leak between the two groups (1.64% vs 0.97%, P = 1.000).

Figure 2 Postoperative complication occurrence. CC: Conventional care; FMEA: Failure mode and effects analysis.

Quality of life

Evaluation of the preoperative comfort between the CC group and the FMEA group demonstrated no significant differences across various dimensions of comfort (Table 3). Specifically, the physiological comfort scores were similar between the CC group (15.27 ± 2.53) and the FMEA group (15.34 ± 2.42, P = 0.818). Psychological comfort showed no significant difference, with the CC group scoring 18.21 ± 2.13 and the FMEA group scoring 18.66 ± 2.08 (P = 0.113). Similarly, the social comfort scores did not differ significantly between the two groups, with the CC group at 19.59 ± 2.46 and the FMEA group at 19.71 ± 2.39 (P = 0.734). The environmental comfort scores were nearly identical, with the CC group scoring 21.39 ± 2.59 and the FMEA group scoring 21.34 ± 2.41 (P = 0.867). The total comfort scores for both groups were comparable, with the CC group at 74.47 ± 5.80 and the FMEA group at 75.05 ± 4.66 (P = 0.415).

Table 3 Preoperative comfort assessment, mean ± SD.

Indicator	CC group (n = 122)	FMEA group (n = 103)	t	P value
Physiological comfort	15.27 ± 2.53	15.34 ± 2.42	0.231	0.818
Psychological comfort	18.21 ± 2.13	18.66 ± 2.08	1.590	0.113
Social comfort	19.59 ± 2.46	19.71 ± 2.39	0.340	0.734
Environmental comfort	21.39 ± 2.59	21.34 ± 2.41	0.168	0.867
Total score	74.47 ± 5.80	75.05 ± 4.66	0.816	0.415

CC: Conventional care; FMEA: Failure mode and effects analysis.

Evaluation of postoperative comfort between the two groups showed significant differences across several dimensions of comfort (Table 4). The FMEA group reported significantly higher scores in physiological comfort (22.26 ± 2.31 vs 21.37 ± 2.42, P = 0.006). Similarly, psychological comfort was higher in the FMEA group (24.29 ± 2.59 vs 23.56 ± 2.75, P = 0.043). The social comfort scores were higher for the FMEA group than for the CC group (21.74 ± 2.07 vs 21.09 ± 2.16, P = 0.023). However, no significant difference was noted in the environmental comfort scores between the two groups (23.37 ± 2.41 vs 23.24 ± 2.37, P = 0.685). The total comfort score, which aggregates all dimensions, was significantly higher in the FMEA group than in the CC group (91.66 ± 4.71 vs 89.27 ± 4.87, P < 0.001). These results indicate that the FMEA group experienced better overall postoperative comfort across multiple dimensions, including physiological, psychological, and social aspects.

Table 4 Postoperative comfort assessment, mean ± SD.

Indicator	CC group (n = 122)	FMEA group (n = 103)	t	P value
Physiological comfort	21.37 ± 2.42	22.26 ± 2.31	2.793	0.006
Psychological comfort	23.56 ± 2.75	24.29 ± 2.59	2.034	0.043
Social comfort	21.09 ± 2.16	21.74 ± 2.07	2.285	0.023
Environmental comfort	23.24 ± 2.37	23.37 ± 2.41	0.406	0.685
Total score	89.27 ± 4.87	91.66 ± 4.71	3.723	< 0.001

CC: Conventional care; FMEA: Failure mode and effects analysis.

Assessment of ADL before and after treatment between the CC group and the FMEA group revealed that the baseline ADL scores prior to any intervention were similar in both groups (Table 5). Specifically, the CC and FMEA groups had mean scores of 55.97 ± 3.92 and 55.88 ± 3.81, respectively, showing no significant difference (P = 0.863). However, the post-treatment ADL scores revealed notable differences. After treatment, the FMEA group demonstrated a significantly higher ADL score than the CC group (67.93 ± 3.19 vs 66.71 ± 3.35, P = 0.006). This finding indicates that the FMEA group experienced greater improvement in their ability to perform daily activities following the procedure.

Table 5 Activities of daily living, mean ± SD.

Indicator	CC group (n = 122)	FMEA group (n = 103)	t	P value
Before treatment	55.97 ± 3.92	55.88 ± 3.81	0.173	0.863
After treatment	66.71 ± 3.35	67.93 ± 3.19	2.775	0.006

CC: Conventional care; FMEA: Failure mode and effects analysis.

Functional and symptom domains were assessed before and after treatment between the two groups (Figure 3). At baseline, no significant differences were found in the quality of life scores between the two groups. For the functional domain, the CC and FMEA groups had mean scores of 31.02 ± 2.46 and 30.97 ± 2.28, respectively (P = 0.874). Similarly, for the symptom domain, the CC group scored 10.36 ± 1.68, and the FMEA group scored 10.41 ± 1.59 (P = 0.805). These results indicate that both groups started with comparable baseline quality of life scores. Post-treatment assessments revealed significant differences between the two groups. In the functional domain, the FMEA group showed a higher score than the CC group (39.56 ± 2.37 vs 38.78 ± 2.42, P = 0.015). In the symptom domain, the FMEA group also demonstrated better outcomes (14.64 ± 1.26 vs 14.09 ± 1.31, P = 0.002).

Figure 3 Quality of life assessment. A: Function domain before treatment; B: Symptom domain before treatment; C: Function domain after treatment; D: Symptom domain after treatment. CC: Conventional care; FMEA: Failure mode and effects analysis.

Patient satisfaction

In assessing patient care satisfaction between the CC group and the FMEA group, significant differences were observed in the levels of satisfaction reported by patients (Table 6). For patients reporting being “very satisfied”, a significantly higher proportion was noted in the FMEA group (61.17%) than in the CC group (47.54%, P = 0.041). In terms of “generally satisfied” responses, the proportion was slightly lower in the FMEA group (34.95%) than in the CC group (45.08%), but this difference did not reach statistical significance (P = 0.123). Additionally, fewer patients in the FMEA group reported being “dissatisfied” (3.88%) than in the CC group (7.38%), although this difference was also not statistically significant (P = 0.263).

Table 6 Patient care satisfaction, n (%).

Indicator	CC group (n = 122)	FMEA group (n = 103)	χ2	P value
Very satisfied	58 (47.54)	63 (61.17)	4.170	0.041
Generally satisfied	55 (45.08)	36 (34.95)	2.380	0.123
Dissatisfied	9 (7.38)	4 (3.88)	1.252	0.263

CC: Conventional care; FMEA: Failure mode and effects analysis.

DISCUSSION

Compared with traditional care, an FMEA-based care plan for patients undergoing laparoscopic extended radical colectomy improves postoperative recovery by accelerating the return of basic physiological functions, reducing complications, and enhancing quality of life and patient satisfaction. This systematic risk-oriented approach surpasses standardized traditional protocols in enhancing patient recovery.

The accelerated gastrointestinal recovery in the FMEA group is a key finding, marked by early return of bowel sounds, flatus, and defecation, and shortened time to tolerate liquid and solid diets. By planning the postoperative care pathway and using FMEA to identify key risk factors, the care team can proactively intervene against factors, such as inadequate pain control leading to opioid overuse, poor fluid management, delayed mobilization, and lack of standardized chewing gum protocols, before complications arise, thereby mitigating intestinal motility disorders[21]. Early passage of gastrointestinal motility and quicker tolerance of liquid and solid diets may reflect a more coordinated strategy emphasizing early ambulation, multimodal pain control, and timely nutritional support[22]. Similar benefits have been noted in ERAS programs, but these protocols often focus on standardized order sets, without detailed analysis of failure points[23]. The present study extends the ERAS concept by embedding a formal risk assessment layer addressing the reasons behind delayed gut function rather than merely prescribing what should be done. A previous study on gastric cancer surgery similarly found that FMEA models reduced postoperative ileus, supporting the conclusion that systematic preemptive analysis effectively alleviates this complication[24]. Accelerated recovery of gastrointestinal function shortened the hospital stay in the FMEA group, a difference that, although minimal, holds important clinical and economic implications. Clinically, this indicates improved recovery quality and healthcare processes with enhanced efficiency. From a management perspective, this leads to an increased bed turnover rate and enhanced efficiency in the use of resources[25]. Further reduction in hospital stays can decrease the risk of hospital-acquired infections, help patients return home more quickly, and promote psychological recovery and improvements in quality of life[26].

In terms of functional recovery assessment, the results of the 6MWD test and the sit-to-stand test provide objective evidence of the benefits of the FMEA protocol. The 6MWD test is a standard method for assessing submaximal exercise endurance, directly reflecting the patient’s ability to perform daily physical activities[27]. The increase in walking distance in the FMEA group indicates enhanced cardiopulmonary function and overall physical recovery, enabling patients to better perform daily activities such as prolonged walking. The sit-to-stand test specifically assesses lower limb muscle strength, balance, and the basic action of transitioning from sitting to standing, which is closely related to key life activities such as toileting and transferring[28]. Improvements in this test in the FMEA group demonstrate enhanced fundamental motor functions and independent living abilities of the patients. The improvement can be attributed to several factors. First, faster recovery of gastrointestinal function and reduced complications like nausea and abdominal distension enable patients to engage more fully in early activities. Second, the FMEA process addresses barriers to rehabilitation, such as fear of pain or wound complications, by enhancing education, support, and pain management[29]. The FMEA protocol promotes sustained functional recovery by optimizing each step from bed rest to ambulation. The present study extends previous research, showing that FMEA not only prevents errors but also actively enhances patient outcomes, including physical rehabilitation[30]. While FMEA has been used to improve physical therapy safety, this study demonstrates its direct benefits on patient-level functional indicators.

The FMEA cohort had lower incidences of complications like nausea, vomiting, ileus, and abdominal distension than the CC cohort. For nausea and vomiting, FMEA involves reviewing perioperative drug administration, anesthesia techniques, and dietary protocols to develop enhanced preventive strategies[31]. This reduces risks from improper opioid use and mechanical factors like inadequate bowel preparation or delayed mobilization[32]. Notably, the reduction in ileus is evident because it can be influenced by surgical techniques and postoperative care, including early activity and careful opioid use, which prevent adhesions and obstruction[33]. These findings align with FMEA’s success in reducing adverse events in other high-risk clinical processes such as chemotherapy and blood transfusion[34].

The FMEA model enhances patient comfort through systematic risk assessment across physical, psychological, social, and environmental dimensions. Improved symptom control and accelerated gastrointestinal recovery reduce pain, and clear risk communication and proactive guidance lower anxiety and boost a sense of control[35]. Family involvement in educational sessions strengthens support networks, and better bedside ergonomics, along with timely equipment checks, create a safer care environment. These improvements align with early oncology care research, showing that comprehensive risk assessment can enhance patient comfort[36]. Within the FMEA framework, ADL and overall quality of life improve as functional independence reduces psychological burden and increases health satisfaction[37]. Fewer complications also mean less need for additional interventions, thus preserving physical and mental health. FMEA offers greater improvements in ADL and quality of life than ERAS protocols.

Patient satisfaction was higher in the FMEA group due to a faster, smoother recovery process and more comprehensive support, which improved functional independence. The FMEA approach emphasizes process optimization and failure prevention, offering a coherent, predictable, and patient-centered care experience with fewer delays, clearer communication, and effective management of expectations and symptoms[38]. Patient satisfaction reflects clinical outcomes and the perceived quality of communication, responsiveness, and empathy. By requiring clear documentation of each care step, FMEA enhances transparency and accountability, making patients feel that the care team is vigilant, proactive, and responsive, thus increasing trust and satisfaction[39]. This finding aligns with those of other literature on using FMEA to improve emergency waiting times and outpatient processes, showing its applicability in major cancer surgeries[40].

Despite these encouraging findings, several limitations affect the interpretation of the results. The retrospective and single-center design introduces the possibility of selection bias and limits the generalizability of the results. The inherent limitations of a retrospective review mean that unmeasured confounding factors may influence the outcomes. The relatively short follow-up period captured the immediate and early recovery phases but did not provide information on the long-term sustainability of the observed benefits, such as sustained functional advantages or long-term complication rates. A formal cost-effectiveness analysis of the FMEA protocol implementation was not conducted, which could be valuable for hospital administrators.

Future research should aim to validate these results in multicenter, prospective randomized trials with long-term follow-up to assess the durability of the benefits. Additionally, investigating the specific components of the FMEA protocol that have the most impact could help refine and streamline interventions. Finally, integrating a cost-effectiveness analysis could determine whether the resource investment required for comprehensive failure mode assessment can yield favorable economic returns for the health system.

CONCLUSION

The FMEA nursing model significantly enhances functional recovery, reduces complications, and improves quality of life in patients with CRC undergoing laparoscopic extended colectomy. Its implementation represents a clinically valuable strategy for optimizing postoperative rehabilitation within enhanced recovery protocols.