Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study.

BACKGROUND: Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations. The aim of this study was to prospectively evaluate the role of video-assisted thoracic surgery (VATS) compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resections. PATIENTS AND METHODS: A total number of 120 patients undergoing elective pulmonary sublobar wedge resection were randomly assigned to VATS (n = 60) or mini-muscle-sparing thoracotomy (n = 60). The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints.
RESULTS: Patients' baseline demographic and clinical data did not differ among study arms as well as the number of pulmonary segments resected and the morphology of the nodular lesions. Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006). Multivariate analysis revealed that VATS approach was inversely associated with longer inhospital stay whereas the number of resected segments was positively associated with an increased duration of hospitalization. Patients in the VATS group were less likely to develop atelectasis (≥1 lobe) compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042). Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560).
CONCLUSION: VATS was associated with shorter duration of hospitalization positively affecting the patients' quality of life and satisfaction. Significant suppression of the total cost of recovery after thoracoscopic pulmonary resections is expected.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

Thoracic surgical procedures in oncology patients has been shown to increase over the last few years reflecting the improved efficacy and survival benefit associated with novel cancer therapies; inevitably, this was followed by a significant rise in health care costs. Consecutively, thoracic surgeons are expected to diminish resource utilization while operating on an increasingly high-risk, aging population, without compromising patient safety and quality of care. Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations.[1]

Fast-track thoracic surgery pathways were developed aiming to reduce both postoperative morbidity and mortality and expedite hospital discharge.[2] An important step in fast-tracking pulmonary resections is the early removal of chest tubes that cause pain, impair mobility and impose a risk of infection.[23] Video-assisted thoracic surgery (VATS) is the cornerstone of modern thoracic surgery allowing earlier mobilization of the patients.[456] The aim of the present study was to prospectively evaluate the role of VATS compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resection.

PATIENTS AND METHODS

Study population and design

From July 2011 to March 2014, 120 patients undergoing elective pulmonary sublobar wedge resections in our centre were prospectively enrolled and randomly assigned to VATS (n = 60) or mini-muscle-sparing thoracotomy (n = 60). The fast-track protocol for the study included the following steps:

Careful preoperative patient selection,

A fast-track anaesthetic technique,

Surgery at normothermia,

Early postoperative extubation in the operating room and admission to the thoracic surgery ward,

Early postoperative mobilization from the day of surgery and

Early hospital discharge.

Eligibility criteria for study entry were age <75 years, forced expiratory volume in 1 s (FEV1) ≥1 and American Society of Anaesthesiologists (ASA) classification system ≤3. Exclusion criteria included emergency surgery and reoperation. Eligible patients were randomized based on computer-generated random allocations. The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints. Complications considered included atelectasis of ≥1 pulmonary lobe on chest X-ray and prolonged airleak (>5 days). Postoperative cardiopulmonary morbidity was defined as myocardial infarction, pulmonary embolism or respiratory failure. Both inhospital mortality and 30-day mortality were recorded. The study design is illustrated in Figure 1. The study protocol was approved by our Institutional Research Ethics Committee and all patients provided written informed consent before their enrolment. The study was registered at ClinicalTrials.gov, identification number NCT01397045.

Figure 1

Flowchart depicting study design

Surgical technique

In mini-muscle-sparing thoracotomy group, access to the pleural cavity was obtained by a limited (4-5 cm) posterolateral thoracotomy, preserving latissimus dorsi and partially dividing serratus anterior muscle. In the VATS group, three stab incisions were made over the lateral thoracic wall (three holes technique). The lowest hole was located at the midaxillary line just above the level of the diaphragm and served as the entrance point for a 0° Fiber Optic camera (Storz). The other two incisions were carried out at the posterolateral and the anterolateral thoracic wall respectively under direct thoracoscopic vision, in such a way as to facilitate the access to the pulmonary lesions. In both groups, a 60 mm endostapler was used in order to perform pulmonary sublobar wedge resection. One 32 French chest tube was placed at the completion of the operation.

Anaesthetic and postoperative management

All patients received premedication and anaesthesia induction using the same method. Tracheal intubation was achieved using a double-lumen tube under bronchoscopic guidance in all cases. Patients' arterial blood pressure (BP), electrocardiogram (ECG), oxygen saturation (SpO2), end-tidal carbon dioxide (ETCO2) and blood gases were constantly monitored. Early postoperative extubation in the operating room and admission to the ward was attempted in all patients. Postoperative systemic analgesia was identical for both groups. Early mobilization of all patients within the day of surgery was pursued. The thoracic tube was removed when the output was <200 mL in 24 h and no air leakage was present.

Statistical analysis

Values of continuous data are presented as mean ± standard deviation, whereas categorical variables as absolute numbers and percentages. Normal distribution was assessed by the Kolmogorov-Smirnov test. Comparison of means was performed using Student's t-test and Mann-Whitney U test where appropriate. Comparisons between percentages were performed using Chi-square test. Forward linear regression analysis was applied to identify independent predictors of inhospital stay using an F probability of 0.05 and 0.10 for variable entry and removal from the model respectively. Kaplan-Meier analysis was employed to assess 30-day mortality rates and comparison between treatment arms was performed using the log-rank test. The level of statistical significance was set at 0.05. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) 17.0 software (SPSS, Chicago, IL, USA) for Windows.

RESULTS

Patients' baseline demographic and clinical data are presented in Table 1. No difference was detected between patients allocated in the two study arms. Perioperative data are presented in Table 2. The number of pulmonary segments resected was similar in both groups. The morphology of the nodular lesions (nonneoplastic, neoplastic primary malignant or neoplastic secondary malignant) did not differ between groups either.

Table 1

Preoperative patients' characteristics per treatment group assigned; data are means ± standard deviation or absolute numbers (percentages)

Table 2

Intraoperative parameters, postoperative complications, cardiopulmonary morbidity, inhospital stay and 30-day mortality; data are means ± standard deviation or absolute numbers (percentages)

Primary outcome

Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006) [Table 2].

Forward linear regression analysis was applied to identify the strongest predictors of inhospital stay among the following preoperative and perioperative parameters: Age, gender, body mass index (BMI), ASA classification status, Tiffeneau index [FEV1/forced vital capacity (FVC)], history of coronary artery disease, hypertension, atrial fibrillation, diabetes mellitus, chronic kidney disease with baseline serum creatinine >2 mg/dL, peripheral vascular disease, type of current procedure and number of segments resected. Multivariate analysis revealed that VATS procedure and the number of segments resected were independent predictors of inhospital stay [Table 3]. The VATS approach was inversely associated with longer inhospital stay, whereas the number of resected segments was positively associated with increased duration of hospitalization.

Table 3

Multivariate predictors of inhospital stay identified by forward linear regression analysis (only the final step shown)

Secondary outcomes

Patients in the VATS group were less likely to develop atelectasis (≥1 lobe) compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042) [Table 2]. Prolonged air leak (persisting for more than 5 days) showed a higher incidence after thoracotomy, compared to VATS, although, this difference did not reach statistical significance (25% versus 11.7% respectively, P = 0.059) [Table 2].

Major cardiopulmonary morbidity was noted in one (1.7%) patient in the VATS group and in three (5%) patients in the thoracotomy group (P = 0.309) [Table 2]. Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560).

DISCUSSION

This study confirmed that patients undergoing video-assisted pulmonary sublobar wedge resections experience shorter postoperative inhospital stay compared to those operated using the mini-muscle-sparing thoracotomy approach. A lower incidence of prolonged air leak and atelectasis in the VATS arm may at least in part account for this difference. However, major cardiopulmonary morbidity and 30-day mortality were not significantly different between the two approaches.

Fast-track rehabilitation is universally accepted as an established measure to minimize postoperative length of stay.[2567] VATS has been already incorporated in fast-track protocols aiming to further reduce the duration of hospitalization. Although, it is considered a standard of care in the majority of thoracic surgery units facilitating earlier patient ambulation and chest tube removal, a trend toward premature chest tube withdrawal despite the amount of fluid drainage or even omitting it completely has been emerged.[8910] This policy probably originates from the continuous need for additional cost suppression. However, its implementation depends on the availability of a well organised close outpatient follow-up in order to identify early possible complications that may set patients' health at risk.[910]

Lack of such potentiality characterizes many thoracic surgery units, especially in developing countries. In these cases, it is considered hazardous to apply a protocol targeting in premature chest tube removal and hospital discharge. Reduced inhospital length of stay was observed in patients operated using the totally thoracoscopic three holes technique. VATS clearly favours earlier mobilization decreasing postoperative complication rates leading to significant shorter duration of hospitalization. The incidence of atelectasis depicted in X-ray of the chest was recorded higher in the thoracotomy group of patients probably due to trauma-related pain despite analgesic measures. Its effect on prolonged inhospital stay regarding the aforementioned group is beyond any doubt.

Furthermore, multivariate analysis identified two independent predictors of prolonged hospital stay; VATS approach was associated with significant decreased inhospital length of stay, while the number of resected segments was positively associated with prolonged duration of hospitalization as expected. The beneficial impact of thoracoscopic procedure over mini-muscle-sparing thoracotomy lies on the fact that it is minimally invasive, allowing easier pain control as well as improved respiratory function.[11] Based on the study by Refai et al., the intensity of postoperative pain is correlated with shallow breathing and in coordination with chest physiotherapy leading to decreased ventilatory function, which is supported by spirometric data.[12] Minimizing pain allows deeper breathing movements enhancing pulmonary function, while preventing respiratory complications, especially atelectasis.[1213] As a result, full lung expansion is achieved earlier, restricting possible air leaks originating from dissection of the interlobar fissure as well as diminishing pleural fluid production. The combination of these benefits attributed to VATS approach permit earlier chest tube withdrawal and hospital discharge.

It has been suggested that chest tube removal may ameliorate FEV1.[14] In addition, improved physical performance as well as vital capacity has been recorded after early chest tube withdrawal.[914] In order to achieve fast-track recovery following pulmonary resections, it is essential to remove, as early as possible, the chest tubes without, however, compromising patients' safety and the quality of care.[15] Significant shorter duration of hospitalization observed in the VATS group of patients was mainly explained by the earlier chest tube removal. This finding has potential economic benefits.[9] Based on data from the financial department, it was estimated that our institution was able to save €434.67 per patient assigned in the VATS group of this trial.

Regarding this prospective study, patients' safety as the ultimate priority, lead the authors to delay chest tube withdrawal and hospital discharge until absolutely no air leak was recorded and fluid drainage was <200 mL/24 h. Despite this serious limitation, this trial confirmed the efficacy of VATS in promoting fast-track rehabilitation. Moreover, the number of participants was generally limited because of its single-institutional nature. The strength of the current trial was the prospective randomization design, the quality of the randomization and the uniformity of both surgical and anaesthetic techniques.

CONCLUSION

In conclusion, earlier chest tube removal and shorter duration of hospitalization may influence patients' quality of life and satisfaction. However, additional cost benefits derive from implementation of fast-track protocols in daily practice. Integration of VATS in these protocols is of paramount importance, allowing significant suppression of the total cost of recovery after pulmonary resections. The financial impact of VATS approach should be further evaluated in cost-effectiveness studies.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

None of the authors have any conflicts of interest to declare.