ERAS for Free Fibula Flap Surgery: Effects on Postoperative Recovery and Complications

doi:10.21203/rs.3.rs-2726356/v1

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ERAS for Free Fibula Flap Surgery: Effects on Postoperative Recovery and Complications

https://doi.org/10.21203/rs.3.rs-2726356/v1

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published 03 Jan, 2024

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This study aimed to evaluate the effects of the enhanced recovery after surgery (ERAS) program on postoperative recovery of patients who underwent free fibula flap surgery.This retrospective study enrolled 188 patients who underwent free fibula flap surgery between January 2018 and December 2022; after propensity score matching, the ERAS and non-ERAS groups included 36 patients each. The primary outcome was the length of intensive care unit stay; the secondary outcomes were flap complications, unplanned reoperation, 30-day readmission, postoperative ventilator use length, surgical site infections, lower-limb comorbidities, and morbidity parameters.There were no significant differences in the demographic characteristics of the patients. However, the ERAS group showed lower length of intensive care unit stay (ERAS vs non-ERAS: 8.66 ± 3.90 days vs. 11.64 ± 5.42 days, P = 0.027) and post-operative ventilator use days (ERAS vs non-ERAS: 1.08 ± 0.28 days vs. 2.03 ± 1.05 days, P < 0.001). Other secondary outcomes were not significantly different between the two groups. Additionally, patients in the ERAS group had lower postoperative morbidity parameters, such as postoperative nausea, vomiting, urinary tract infections, and pulmonary complications (P = 0.044).The ERAS program could be beneficial and safe for patients undergoing free fibula flap surgery, thereby improving their recovery and not increasing flap complications and 30-day readmission.

Health sciences/Medical research

Health sciences/Signs and symptoms

In 1975, Taylor et al. performed the first successful harvest and transfer of a free fibula using a posterior approach [1]. This technique was later improved by Gilbert, who introduced the lateral approach. Subsequently, Wei et al. popularized the osteomyocutaneous fibular flap, further advancing the procedure. [1, 2] In 1994, Hidalgo expanded the indications for fibular free tissue transfer by developing osteotomy techniques that permitted fibula reshaping to resemble the mandible. Consequently, the fibula has become a highly versatile element of head and neck reconstruction. [3]

Fibular bone can be used in reconstruction in various ways, including cancellous and cortical autografts, bone allografts, endoprosthetic replacement, vascularized bone grafts, fibular osteocutaneous flaps, and fibular osteomuscular flaps. [4–6] Among these options, free vascularized fibular grafting has gained prominence as it provides immediate mechanical support and has the potential for growth or hypertrophy, according to the patient’s condition. [7] However, the occurrence of complications is influenced by various perioperative factors: anesthesia-related complications (nausea and vomiting, respiratory depression, aspiration pneumonia, and hypothermia) [8]; intraoperative complications (improper fixation, neurovascular bundle damage, graft length discrepancy, or bleeding) [9]; and postoperative complications (graft fracture, surgical site infection, gait disturbance due to pain, equine deformity of the ankle, amputation, nerve injury with sensory loss or motor deficit or anastomosed vessel thrombosis, and partial or complete flap failure) [10–14]. To improve the quality of life of patients and reduce complications, it is crucial to optimize perioperative management.

In 1997, Kehlet first introduced the concept of enhanced recovery after surgery (ERAS) to promote quick patient recovery, restore normal activity levels, and reduce the length of hospital stay after surgery, leading to a decrease in complication rates and hospitalization costs [15]. Subsequently, many specialties have adopted ERAS programs, which have become the standard of care for several surgical procedures [16–24], as confirmed by various systematic reviews and meta-analyses [25–33]. However, to the best of our knowledge, no studies have evaluated the impact of ERAS focusing solely on patients undergoing fibula flap surgery [34]. As prospectively performing a randomized controlled trial with a sufficient number of patients undergoing high-risk surgery is challenging, a propensity score matching (PSM) analysis can minimize selection bias and increase the level of evidence. Therefore, this novel study was conducted to assess the feasibility, safety, and efficacy of an adapted ERAS protocol in patients undergoing free fibular flap surgery using a PSM analysis.

Design, Setting, and Participants

This retrospective case-control study included 188 patients who underwent free fibula flap surgery performed by a single surgical team at our institute between January 2018 and December 2022. Patients with metastatic cancer (stage IV), those who did not intend to undergo curative treatment, and those with incomplete demographic data were excluded from the study. This study adheres to the principles of the Declaration of Helsinki, which provides ethical guidelines for medical research involving human subjects. The study obtained approval from the National Taiwan University Hospital Research Ethics Committee (approval number: 202302021RIN) to ensure compliance with ethical guidelines. Due to the retrospective nature of the study, the requirement for written informed consent was waived by the ethics committee. However, all patient data were kept confidential and anonymous. All processes in this study were conducted in accordance with ethical principles and regulations to protect the rights and welfare of human subjects. It is essential to uphold these ethical standards when conducting research involving human subjects.

Matching And Statistical Analyses

Patients were enrolled in the study if they received a free fibular flap for oromandibular reconstruction. Patients in the ERAS group were enrolled between January 2021 and December 2022, and those in the non-ERAS group were enrolled between January 2018 and December 2020. The plastic surgery team provided care to patients in both groups. To reduce selection bias, potential statistically significant (P < 0.5) predictors closely related to surgery were included. We matched 188 patients with respect to age, sex, and smoking status using the PSM method (caliper width 0.1, standard deviation of the propensity score). The matching used a 1:1 ratio greedy nearest-neighbor matching approach, with a maximum propensity score difference of ± 1%. We calculated the standardized mean difference for each matched variable to determine PSM success. Ultimately, ERAS and non-ERAS groups included 36 patients each. Patient demographics, comorbidities, baseline health markers, and clinical outcomes were compared between the ERAS and non-ERAS groups using t-tests. Categorical variable differences between the ERAS and non-ERAS groups were assessed using chi-square or Fisher’s exact tests. Correlation analysis was used to assess the association between these factors and length of stay (LOS). Regression analysis was used to assess the significant association between the LOS factors and LOS prediction. For statistical analyses, a P-value < .05 was considered significantly different. PSM and statistical analyses were performed using SPSS software (version 26.0; SPSS, Inc., Chicago, Illinois, USA).

Outcome Measures

The primary outcome measure was LOS; secondary outcomes included flap complications, such as total flap loss, unplanned reoperation within 30 days, 30-day readmission, postoperative ventilator use length, vasopressor use, surgical site infections, and lower limb comorbidities [13, 14, 35], including peroneal nerve injury-induced sensory loss or foot drop. Other morbidity parameters include postoperative nausea and vomiting (PONV), urinary tract infections, and pulmonary complications. All data were collected from electronic medical records.

Eras And Non-eras Intervention

When ERAS programs were introduced in our hospital, there were no clear guidelines for free fibular flap surgery. Therefore, we adopted and improved the general ERAS principles [31–33] and established ERAS programs at our hospital. Before surgery, the care protocol was similar in both groups, including administering intravenous (IV) crystalloids to replace fluids at the time of admission. Empirical IV antibiotics were administered to patients in both groups. Central venous pressure was used to calculate the fluid requirements. The non-ERAS group included patients who had received treatment according to traditional perioperative programs. Detailed variations in the postoperative programs for both groups are presented in Table 1-1&1-2.

Table 1

1. Protocols in the ERAS and non-ERAS groups (Pre and Intra-operative)
Program List	ERAS group	Non-ERAS Group
Preoperative
Clinical shared decision-making of ERAS	Yes	No
Consult Physiotherapist	Apply posterior ankle-foot-orthosis Education isometric and isotonic exercise on the bed	After transfer to the general ward
Nutritional assessment and intervention	Use MUST Score, patients with severe nutritional risk should be provided enteral nutrition supportive treatment	No
Organ function evaluation	Yes, check hematological, renal, kidney, liver, and coagulation function	Yes, similar to the ERAS group
Fasting and abstinence from drinking	Eating was allowed up to 6 hours before surgery, and carbohydrate drinks were allowed to be consumed up to 2 hours before surgery	Fasting and drinking for 8 hours before the operation
Intraoperative
Prevention of antibiotic use	Yes, include both aerobic and anaerobic bacteria	Yes, include both aerobic and anaerobic bacteria
Liquid management	Keep input/output balance Maintain urine output 0.5–1 cc/kg/hour	No
Intraoperative safety check	Use time-out checklist	Use time-out checklist
Anesthesia	General anesthesia	General anesthesia
Temperature management	Maintain the core temperature of the patient not less than 36°C (preheating fluid replenishment, thermal blanket, heater)	No
MUST: Malnutrition Universal Screening Tool;

Table 1

2. Protocols in the ERAS and non-ERAS groups (Postoperative)
Program List	ERAS group	Non-ERAS Group
Postoperative
Postoperative analgesia	Multimodal analgesia (Opioid, NSAIDs, acetaminophen, COX-2 inhibitors, α-2 agonists) Patient-controlled intravenous analgesia maintained until POD 2 or POD 3	Opioid analgesia
Airway management (SpO₂ should be maintained above 90%)	Tracheostomy with ventilator support and structure weaning program by RT, early withdrawal ventilator use within 24 hours	Tracheostomy with ventilator, weaning by RT, or Physician decision
Postoperative nausea and vomiting prevention	5-HT3 receptor antagonists are used prophylactically for the first 24 hours	No
Flap monitoring	Monitor of color, temperature, and Doppler of recipient site by physician order	Similar to ERAS group
Donor site and drain management	Negative pressure wound therapy, early tube removal (latest POD 5)	Gauze cover Routine indwelling before discharge
Delirium prevention	Routing use dexmedetomidine and avoid midazolam	Use midazolam or Physician decision
Postoperative nutritional support	Sequential EN treatment after awakening	Gradually start EN after awakening
Early mobilization	Bedside ambulation from POD 1 (head up -> limb movement isometric and isotonic exercise on the bed) Use posterior ankle-foot-orthosis	Ambulation on transfer to the general ward
Education before discharge	Yes	Yes
NSAIDs: Non-steroidal anti-inflammatory drugs; COX-2: Cyclooxygenase-2; POD: postoperative day; RT: Respiratory Therapist; 5-HT3: Selective serotonin receptor; EN: Enteral nutrition; SpO₂: oxygen saturation

Table 2

Patient Demographics and Anesthetic and Operative Data
	ERAS Group	Non-ERAS Group	P Value
Sample size	36	36
Age, years	56 ± 14.88	55.69 ± 12.21	0.92
Sex, male/female	29/7	25/11	0.21
BMI	22.50 ± 3.30	23.05 ± 3.84	0.91
Smoker	34	32	0.34
KPS			0.50
80–100	29	30
50–70	7	6
0–40	0	0
Diagnosis			0.39
Cancer	29	29
Non-cancer	9	7
ASA grade
I	0	0
II	8	5	0.27
III	28	31	0.27
IV	0	0
Operative time, minutes	902.31 ± 130.98	836.39 ± 229.79	0.12
Intraoperative blood loss, mL	298.61 ± 169.23	271.33 ± 128.49	0.44
Values are reported as numbers or mean ± SD. SD, standard deviation; ERAS, enhanced recovery after surgery; BMI, body mass index (weight (in kilograms) ÷ height (in meters)); ASA, American Society of Anesthesiologists; KPS, Karnofsky Performance Status Scale

Patients

After PSM, the present study included a total of 72 patients. There were 36 patients in the ERAS group (29 men and 7 women; mean age, 56 ± 14.88 years; mean body mass index [BMI], 22.50 ± 3.30) and 36 patients in the non-ERAS group (25 men and 11 women; mean age, 55.69 ± 12.21 years; mean BMI, 23.05 ± 3.84). The baseline demographic characteristics and operative details of the two groups are compared in Table 2. A comparison of the demographic data revealed no significant intergroup differences. No significant differences in operative time or intraoperative blood loss were observed between the ERAS and non-ERAS groups. The Karnofsky Performance Status Scale (KPS) was used for assessment of preoperative physical function and revealed no significant differences between the two groups (P = 0.50). A KPS score of 0–40 was observed in 0 patients, a KPS score of 50–70 was found in 13 patients (7 patients in the ERAS group vs. 6 patients in the non-ERAS group), and a KPS score ≥ 80 was found in 59 patients (29 patients in the ERAS group vs. 30 patients in the non-ERAS group). No significant differences in preoperative physical status were observed between the two groups. (Table 2)

Compliance With The Eras Protocol

Our ERAS program included 19 component interventions, and the overall protocol compliance was 91.2% (Table 3). The twelve interventions were used in 100% of the cases in the ERAS group, with a 100% compliance rate. The items with relatively low compliance were donor site and drain management (61.1%), early mobilization (61.1%), consult physiotherapist (75%), PONV prevention (77.8%), delirium prevention (83.3%), and clinical shared decision-making and education of ERAS (86.1%).

Table 3

Compliance with ERAS Program or Items
ERAS items	Number (%)
Preoperative ERAS items	92.2%
Clinical shared decision-making and education of ERAS	31(86.1)
Consult Physiotherapist	27(75)
Nutritional assessment and intervention	36(100)
Organ function evaluation	36(100)
No prolonged fasting	36(100)
Intraoperative ERAS items	100%
Antimicrobial prophylaxis	36(100)
Fluid management	36(100)
Intraoperative safety check	36(100)
Multimodal Anesthesia	36(100)
Maintenance of normothermia	36(100)
Postoperative ERAS items	85.7%
Multimodal analgesia	36(100)
Airway management (SpO₂ should be maintained above 90%)	32(88.8)
Postoperative nausea and vomiting prevention	28(77.8)
Flap monitoring	36(100)
Donor site and drain management	22(61.1)
Delirium prevention	30(83.3)
Early enteral feeding	36(100)
Early mobilization	22(61.1)
Education of self-care before discharge	36(100)
Overall compliance (rate)	91.2%
ERAS, enhanced recovery after surgery; SpO₂: oxygen saturation

Primary And Secondary Outcomes

The main clinical outcomes are summarized in Table 4. After ERAS implementation, no significant differences in flap complications were observed between the ERAS and non-ERAS groups. However, the ERAS group showed significant decrease in LOS (ERAS vs non-ERAS: 8.66 ± 3.90 days vs. 11.64 ± 5.42 days, P = 0.027) and postoperative ventilator use length (ERAS vs non-ERAS: 1.08 ± 0.28 days vs. 2.03 ± 1.05 days, P < 0.001). Postoperative morbidity parameters, such as PONV, urinary tract infections, and pulmonary complications, were significantly decreased in the ERAS group, as shown in Table 4. The rates of unplanned reoperation, 30-day readmission, flap complications, vasopressor use at the end of the surgery, surgical site infections, and flap complications were similar in the ERAS and non-ERAS groups.

Table 4

Postoperative Recovery and Complications Outcomes
Outcome Measure	ERAS Group	Non-ERAS Group	P Value
ICU length of stay, days, mean ± SD	8.86 ± 3.90	11.64 ± 5.42	0.027*
Unplanned reoperation	3	4	0.500
30-day readmission	2	1	0.500
Flap complication (flap loss)	3	3	0.663
Postoperative ventilator, days, mean ± SD	1.08 ± 0.28	2.03 ± 1.05	< 0.001*
Off vasopressors at end of surgery	3	7	0.154
Surgical site infections	0	3	0.120
Lower limb comorbidities	3	7	0.130
Morbidity Parameters			0.044*
PONV	2	8
Urinary tract infection	0	2
Pulmonary complications	2	4
ERAS, enhanced recovery after surgery; PONV, postoperative nausea, and vomiting; SD, standard deviation

The results showed that our ERAS program was beneficial and safe for patients undergoing free fibula flaps surgery. The LOS, postoperative ventilator use length, and morbidity parameters were lower in the ERAS group than those in the non-ERAS group, without any observed increase in 30-day readmission or flap complications. In the present study, a retrospective study of 16 ERAS protocols for flap-based reconstruction found that ERAS principles have been widely and effectively applied to various flap types. A meta-analysis of 12 comparative studies (eight for breast reconstruction and four for head and neck reconstruction) found that ERAS protocols significantly reduced the LOS without affecting complication rates [34]. In this study, the patient demographic characteristics of the two groups were similar and the same surgical procedure was used, leading to no difference in the surgical or pathological results. However, the ERAS group had faster postoperative recovery and shorter hospital stays than the non-ERAS group, and these results were closely related to the ERAS protocol. ERAS is a multimode perioperative management program designed to achieve rapid postoperative rehabilitation, including preoperative education, rehabilitation, preoperative nutritional assessment and intervention, anesthesia mode, multimodal analgesia, early nutrition and activity, and removal of drainage tubes and catheters as soon as possible.

This study was based on three phases, and 19 core ERAS components. In our study, the compliance with ERAS was 91.2%. Furthermore, the intra-operative ERAS items had the highest compliance rates (100% for all items). Similar to previous study, the variance in compliance of individual ERAS components suggests the probability of high compliance rates (with an average above 90%) [38]. The items with relatively low compliance included donor site and drain management (61.1%), owing to the utilization of negative pressure wound therapy at the donor site. As this is not covered by health insurance and requires self-payment, patients with poor economic status are unable to afford its cost. Additionally, early mobilization revealed low compliance (61.1%). The low rate of early mobilization compliance following free flap surgery in the past has been attributed to an increased emphasis on bed rest. This may have resulted in a lack of education of the medical team regarding the necessity and importance of lower-limb activity.

Donor-site morbidity is relevant after free fibula flap harvest. According to a previous study, wound healing is the most frequent complication after fibula flap harvest, followed by nerve injury [39.40]. Paresthesia and persistent lower-limb pain or discomfort are present in numerous patients. The peroneal and sensory cutaneous nerves may be injured during flap harvest. Therefore, careful assessment of the patient's risk before surgery is important. Additionally, to reduce complications, measures for nerve protection during the procedure should be adopted. Ankle stiffness, ankle instability, transient peroneal motor loss, or sensory loss may occur after surgery [39]. Although donor site morbidity may not influence the outcome of major or life-threatening conditions, ankle stiffness may increase rehabilitation recovery time and influence the postoperative quality of life. In the ERAS group, immediate postoperative ankle splints were applied to prevent foot drop and ankle stiffness. In our study, the incidence of lower limb comorbidities was lower in the ERAS group (N = 3/36, 8.3%) compared with the non-ERAS group (N = 7/36, 19.4%), despite not having any statistical significance. The present study reported long-term morbidities in 17% of patients, including leg weakness, ankle instability, great toe contracture, and decreased ankle mobility [40]. This emphasizes the importance of ERAS in preoperative consultation with a physical therapist and for application of a posterior ankle-foot-orthosis immediately after the surgery. Further studies with larger sample sizes are required to validate this finding.

However, this study had several limitations. This study had a retrospective design, the sample size was small, and the observation time was limited to the hospitalization period. Owing to the lack of long-term follow-up data, definitive conclusions cannot be drawn from these results. Furthermore, the ERAS and non-ERAS groups were assessed at different times, which may have introduced an analytical bias into the study. Hence, multicenter studies with larger cohorts, prospective studies, and long-term follow-ups are required to confirm the efficacy of our ERAS protocol in patients undergoing free fibula flap surgery.

Although the ERAS program has achieved success globally, there are still many challenges to overcome. ERAS is a postoperative care option that requires continuous improvement and adaptation to different surgical methods and technologies. This approach emphasizes the integration of preoperative, intraoperative, and postoperative care. This study aimed to compare the short-term outcomes of patients who underwent free fibula flap surgery with and without the implementation of the ERAS program using a PSM analysis. The findings suggest that the ERAS protocol can significantly reduce the intensive care unit LOS, postoperative ventilator use days, and morbidity parameters, without increasing postoperative complications and readmission rates. Therefore, the ERAS program can be a safe and beneficial option for patients undergoing free fibula flap surgery.

Acknowledgment:

We would like to thank the 4A1 intensive care team of National Taiwan University Hospital for their assistance with data collection.

Author Contributions:

WL-H: Data collection; Formal analysis; Writing of the original draft

YC-W : Methodology; Validation; Writing-review and editing

HC-T : Conceptualization; Supervision; editing

Data availability statement:

The data underlying the findings presented in this report are available from the corresponding author upon reasonable request. For questions about data access or use, please contact [email protected]

Competing interests statement:

The authors declare that they have no competing interests. The research presented in this report was conducted independently of any funding or other support from outside organizations. None of the authors have any financial or personal relationships that could be perceived as a competing interest in the research presented

Funding

None

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No competing interests reported.

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published 03 Jan, 2024

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ERAS for Free Fibula Flap Surgery: Effects on Postoperative Recovery and Complications

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Abstract

Introduction

Materials And Methods

Design, Setting, and Participants

Matching And Statistical Analyses

Outcome Measures

Eras And Non-eras Intervention

Results

Patients

Compliance With The Eras Protocol

Primary And Secondary Outcomes

Discussion

Conclusions

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1