Randomized Control Trial on the Efficacy of Dual Bronchodilator of Glycopyrronium/Indacaterol for Lung Cancer Surgery: Improvement of Postoperative Pulmonary Function in Both Patients with Chronic Obstructive Pulmonary Disease and Normal Pulmonary Function

Background: A dual bronchodilator, long-acting anticholine drugs (glycopyrronium, LAMA) and the long running β-2 stimulant (indacaterol, LABA), are effective for the treatment of chronic obstructive pulmonary disease (COPD). To evaluate the effectiveness of the perioperative intervention of LAMA/LABA, a randomized prospective trial was performed for the lung cancer patients receiving a lobectomy with normal pulmonary function and COPD. Methods: Based on the results of the preoperative pulmonary function test, 25 patients were diagnosed with COPD [% forced expiratory volume in 1 second (%FEV1) < 70%]. Thirty-seven patients were enrolled as non-obstructive patients (70% ≤ %FEV1), who were randomized into two groups, the LAMA/LABA (n = 19) and the Control group (n = 18). The LAMA/LABA and the COPD groups daily received inhaled LAMA (50 μg) and LABA (110 μg) for 1 week before surgery and for least 4 weeks after surgery. The Control group had no treatment of the dual bronchodilator. The actual values were measured during the perioperative pulmonary function at three points of the preoperative baseline, the postoperative 1 week and the postoperative 4 weeks;these changes and changed ratios were then calculated. The patient-reported outcomes of the quality of life (PRO-QOL) were evaluated by the Cancer Dyspnea Scale (CDS), the COPD assessment test, and the St. George’s Respiratory Questionnaire. Results: Regarding the value of FEV1 at the baseline, that in the LAMA/LABA group was 79.2% ± 6.4% and that in the Control group was 80.9% ± 6.4%, but that in the COPD groups was 57.9% ± 8.7%;there was a significant difference between the COPD and the Control group (p < 0.0001). At the postoperative 1 week point, the FEV1 value in the Control group was 1.3 ± 0.5 L and that in the LAMA/LABA group was 1.7 ± 0.5 L. On the other hand, that in the COPD group was 1.7 ± 0.5 L, which was significantly higher compared to that in the Control group (p = 0.0251 and p = 0.0369). The intervention of LAMA/LABA for the COPD and non-obstructive patients resulted in the less decreased degree of the pulmonary function in FEV1 compared to that in the Control group. Based on the PRO-QOL by the CDS, the intervention of LAMA/LABA significantly reduced the total dyspnea in the LAMA/LABA group compared to that in the Control group (p = 0.0348). Conclusion: The perioperative intervention of LAMA/LABA should lead to maintaining the postoperative pulmonary function of the FEV1 during the lobectomy with COPD and non-obstructive patients and the improvement of PRO-QOL.

Impact of Preoperative Serum Tumor Markers in Patients with Lung Squamous Cell Carcinoma

Background: Several previous researchers have investigated the prognostic value of serum tumor markers, especially carcinoembryonic antigen (CEA). Only a limited number of studies reported the usefulness of serum tumor markers for lung squamous cell carcinoma (SQ). We aimed to examine the significance of serum tumor markers for lung SQ. Methods: Eighty-five lung SQ patients who underwent surgery and followed more than 5-year were included. The ratios of 5-year survivors to all patients in groups with several clinicopathologic factors, including tumor markers, were compared. We also compared the clinicopathologic factors between central type and peripheral type SQ. Results: The majority of patients were male gender and current/ former smokers. Age, pN status, cytokeratin-19 fragment (CYFRA 21-1), squamous cell carcinoma antigen (SCC), and comorbid interstitial pneumonia (IP) were associated with the ratio of 5-year survivors significantly. When patients were compared based on tumor location, high p-stage and CYFRA 21-1 were related to central type SQ. Conclusion: Both SCC and CYFRA 21-1 appeared to be useful prognostic markers for patients with lung SQ. Furthermore, CYFRA 21-1 was related to central type SQ.

Development of a System to Support Surgical Safety-I and Safety-II. Implementation of Resilient Surgical Healthcare for Bleeding Incidents in Thoracic Surgery

Background: Since bleedings in surgery are infrequent and inexperienced, we always try to proceed with surgery assuming a crisis situation, adhere to routine procedures and its standardization. We focus on the bleeding accidents and reveal how to implement a resilient healthcare theory. By clarifying the Safety-I and Safety-II, we developed a system to support surgical safety based on the surgeon’s individual, team, and organization. Material and Methods: We searched 25 cases of bleeding incidents in thoracic surgery, which were obtained from the database of the Project to Collect Medical Near-Miss/Adverse Event Information of the Japan Council of Quality Health Care in April 2018. Retrospectively, we analyzed 13 hemorrhage cases in our department between July 2002 and March 2020. We studied their surgical factors such as procedures, sites and causes of bleeding, response, treatment, and outcomes. Results: The causes of bleeding included damage of the adhesion detachment, insertions of automatic sutures and forceps, detachment of ultrasonic scalpel, vascular taping, removal of resected lung, lymph node dissection, exfoliation of the infiltrated adventitia of vessels, pull-out of vessel, gauze attachment with staple cut-line of vessel, thoracoscopic collision, infectious vascular rupture, detachment of vascular ligature, and suction tube hit. We summarized the variation in the usual controllable and unexpected uncontrollable bleeding and learned how to respond and treat them. We built up the balanced combination of Safety-I and Safety-II in the daily routine work in normal surgery, the patient’s individual factors, the massive bleeding, and its life-threatening crisis. Conclusions: We can learn how to prevent and respond to bleeding accidents by developing a system to support surgical safety (Safety-I and Safety-II). We can flexibly respond to unexpected bleeding disturbances under constraints by adjusting the surgeon’s individuals, team, and organization.

Implementation of Resilience Engineering for Operating Room. Unveiling the Hidden Interactions among Multi-Professionals in a Surgical Team

Background: The implementation of resilience engineering for an operating room is difficult;however, its study would become important for the surgeon’s personal and surgical team in order to develop a new surgical safety management. An expert operator must perform an operation with his surgical team that includes an anesthetist, scrub nurse, and young assistant. However, there exist some gaps among these multi-professionals. Objective: From the viewpoint of an expert operator, to have an operation go well, we would describe how to reconcile their gaps. We will explain the gaps among the multi-professionals in a surgical team, such as hidden interactions between the operator and anesthetist, surgeon and scrub nurse, and expert operator and young assistant. Material and Methods: We assumed three types of interactions among the multi-professionals in the operating theater and we clarified how to bridge the gaps by revealing what the operator thinks, what the anesthetist thinks, what the scrub nurse thinks, and what the young assistant thinks in the surgical team, and by understanding how they perform during surgery. Outcomes: What the expert operator thinks and how he performs in surgery is summarized by the following three items: 1) safety is first, 2) achieving the operative purpose, and 3) fast surgery. We interviewed the surgical team members. In order for the surgery to go well, what the important thing is “safety first” for any surgical professionals. The sentence, “safety is first” is the magic words, such as “open sesame”. They can communicate with each other on the spot and build the team and system. To develop a strong and resilient surgical team, these four behaviors are important to improve the performance as a system: 1) sharing the same goal and same priority, 2) understanding gaps with clear verbal communication. Coming out from own professional boundaries (takotsubo), speaking in words, 3) all of us, having a strong will (iron heart), and learning anger management, and 4) improvising even in difficult situations. Conclusion: We would like to summarize the items learned from my three described scenes, which are 1) to develop a strong and resilient surgical team, 2) what we have to do, and how we have to perform, and 3) how we can develop a team and system.

Implementation of Resilience Engineering for Thoracic Surgery. Reconciling Work-as-Imagined and Work-as-Done

Background: The Work-As-Imagined (WAI) is a plan that is expected to be performed before surgery, and the Work-As-Done (WAD) is the result of work actually done. In order to perform safe and high-quality surgery for the individual surgeon, the surgical team, and hospital organization as a system, we have to reconcile the WAI and the WAD in resilience engineering for the real world of surgical healthcare. Objective: Based on the resilient healthcare theory, we would like to clarify the actual way of reconciling the WAI and WAD in surgery. Material and Methods: As a typical model of thoracic surgery, we use a lobectomy case for lung cancer. We describe a surgeon’s WAI and WAD, and we explain the anticipating, monitoring, responding, and learning based on the resilient healthcare theory. We reveal the gaps between the WAI and WAD during an operation, we consider the surgeon’s thinking and actual performance, and we describe the actual way of reconciling the WAI and WAD for the surgeon and surgical team. Outcomes: We described three scenes in the operating room, which are 1) by individual surgeon: adjustment for intrathoracic adhesion;2) by surgical team: adjustment for pulmonary artery bleeding;and 3) by surgical team with multi-professionals in the operating room: adjustment for life threatening pulmonary artery critical bleeding. Conclusion: In order to implement a resilient healthcare theory in everyday surgical work, it is important that 1) learning of incidents and the experience of doing well for unexpected events as lessons, and 2) constructing a circulation mechanism of anticipating, monitoring, responding, and learning.

Evaluation and Outcome of Surgeon-Reported Incidents regarding Surgical Patient Safety

Background: We retrospectively analyzed incident reports from surgeons to learn about surgical patient safety and improve surgical quality. Material and Methods: For the 10 years and 3 months between February 2007 and May 2017, 236 incident reports from surgeons were collected. The impact levels of the incidents for patients were represented by a degree of adverse influence to a patient (level 0, 1, 2, 3a, 3b, 4a, 4b, and 5). The outcome of the incident reports was evaluated by the profile, cause, surgery-relation, and factor. Results: The level of incidents resulted in level 0 (n = 18, 7.6%), level 1 (n = 28, 11.9%), level 2 (n = 16, 6.8%), level 3a (n = 44, 18.6%), level 3b (n = 94, 39.8%), level 4a (n = 1, 0.4%), level 4b (n = 6, 2.5%), level 5 (n = 15, 6.4%) and others (n = 14, 5.9%). The profiles of the surgery-related incidents (n = 84) showed other unexpected events (15.7%, n = 37), second surgery within 24 hours (9.3%, n = 22), and unexpected excessive bleeding (6.8%, n = 16). The cause of the sur-gery-related incidents involved hemorrhage (n = 45, 53.6%). Except for complications and accidental diseases (n = 77, 32.6%), the occurrence factor of the incidents cited factors of personal behavior (n = 85, 36.0%), human factors (n = 37, 15.7%), environmental equipment (n = 6, 2.5%), and others (n = 31, 13.1%). Conclusions: The perioperative incidents submitted by surgeons were comparatively proved to be a higher influence level for patients such as unexpected events or surgery and second surgery within 24 hours. An incident reporting system is crucial for surgeons to ensure both surgical patient safety and to improve surgical quality. An aggressive reporting attitude should become useful to enhance safety awareness on a facility-wide basis.