Preoperative Phase Research Articles

Results of the observational prospective RealFLOT study

BackgroundPerioperative FLOT (5-fluorouracil, oxaliplatin and docetaxel) has recently become the gold standard treatment for fit patients with operable gastric (GC) or gastroesophageal (GEJ) adenocarcinoma, getting a 5-year overall survival (OS) of 45%, over 23% with surgery alone.MethodsRealFLOT is an Italian, multicentric, observational trial, collecting data from patients with resectable GC or GEJ adenocarcinoma treated with perioperative FLOT. Aim of the study was to describe feasibility and safety of FLOT, pathological complete response rate (pCR), surgical outcomes and overall response rate (ORR) in an unselected real-world population. Additional analyses evaluated the correlation between pCR and survival and the prognostic role of microsatellite instability (MSI) status.ResultsOf 206 patients enrolled that received perioperative FLOT at 15 Italian centers, 124 (60.2%) received at least 4 full-dose cycles, 190 (92.2%) underwent surgery, and 142 (68.9%) started the postoperative phase. Among patients who started the postoperative phase, 105 (51.0%) received FLOT, while 37 (18%) received de-intensified regimens, depending on clinical condition or previous toxicities. pCR was achieved in 7.3% of cases. Safety profile was consistent with literature. Neutropenia was the most common G 3–4 adverse event (AE): 19.9% in the preoperative phase and 16.9% in the postoperative phase. No toxic death was observed and 30-day postoperative mortality rate was 1.0%. ORR was 45.6% and disease control rate (DCR) was 94.2%. Disease-free survival (DFS) and OS were significantly longer in case of pCR (p = 0.009 and p = 0.023, respectively). A trend towards better DFS was observed among MSI-H patients.ConclusionsThese real-world data confirm the feasibility of FLOT in an unselected population, representative of the clinical practice. pCR rate was lower than expected, nevertheless we confirm pCR as a predictive parameter of survival. In addition, MSI-H status seems to be a positive prognostic marker also in patients treated with taxane-containing triplets.

Relationships of stress, anxiety, and related factors with the comfort of caregivers of patients with brain tumor in the preoperative phase

Relationships of stress, anxiety, and related factors with the comfort of caregivers of patients with brain tumor in the preoperative phase

Augmented Reality-Assisted Craniotomy for Parasagittal and Convexity En Plaque Meningiomas and Custom-Made Cranio-Plasty: A Preliminary Laboratory Report.

Background: This report discusses the utility of a wearable augmented reality platform in neurosurgery for parasagittal and convexity en plaque meningiomas with bone flap removal and custom-made cranioplasty. Methods: A real patient with en plaque cranial vault meningioma with diffuse and extensive dural involvement, extracranial extension into the calvarium, and homogeneous contrast enhancement on gadolinium-enhanced T1-weighted MRI, was selected for this case study. A patient-specific manikin was designed starting with the segmentation of the patient’s preoperative MRI images to simulate a craniotomy procedure. Surgical planning was performed according to the segmented anatomy, and customized bone flaps were designed accordingly. During the surgical simulation stage, the VOSTARS head-mounted display was used to accurately display the planned craniotomy trajectory over the manikin skull. The precision of the craniotomy was assessed based on the evaluation of previously prepared custom-made bone flaps. Results: A bone flap with a radius 0.5 mm smaller than the radius of an ideal craniotomy fitted perfectly over the performed craniotomy, demonstrating an error of less than ±1 mm in the task execution. The results of this laboratory-based experiment suggest that the proposed augmented reality platform helps in simulating convexity en plaque meningioma resection and custom-made cranioplasty, as carefully planned in the preoperative phase. Conclusions: Augmented reality head-mounted displays have the potential to be a useful adjunct in tumor surgical resection, cranial vault lesion craniotomy and also skull base surgery, but more study with large series is needed.

SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery trial (PREPARE-ABC): Pilot phase of a multicentre randomised controlled trial.

PREPARE-ABC is a pragmatic multicentre randomised controlled trial including an internal pilot designed to assess the clinical and cost-effectiveness of pre- and postoperative exercise in relation to short- and longer-term postoperative recovery outcomes in colorectal cancer patients undergoing surgical resection. Here, we report on internal pilot phase data for the first 200 patients randomised to the trial, which included prespecified stop-go criteria used to inform the decision to progress to the fully powered trial by the funder. Eligible and consenting patients are randomly assigned (1:1:1) to hospital-supervised exercise, home-supported exercise or treatment as usual (TAU). Randomisation is concealed but clinical teams providing treatment and participants are unmasked. Primary outcomes are 30-day morbidity (Clavien-Dindo) and 12-month health-related quality of life (Medical Outcomes Study Health Questionnaire). Here, we present findings from the prespecified pilot phase which assessed feasibility of site set up, recruitment, adherence and acceptability of trial processes to patients and site staff. Between 9 November 2016 and 18 May 2018, 18sites were set up, with 200 patients randomised to either hospital-supervised exercise (68), home-supported exercise (69) or treatment as usual (TAU) (63). Across the groups, 19 patients did not proceed to surgery or withdrew and 52% experienced a complication. Over half of the participants (57%) in the hospital-supervised group attended ≥6 preoperative sessions and 50% attended ≥5monthly postoperative exercise "booster sessions". In the home-supported group, 70% patients engaged with ≥2 telephone support sessions in the preoperative phase and 80% engaged in ≥5monthly telephone support "booster sessions". Adverse events were reported by 22 patients and three patients reported a serious adverse event. The majority of complications were Clavien-Dindo grades 1-2; however, 16 patients experienced one or more Clavien-Dindo grade 3-4 complication(s). Results of the internal pilot phase confirm the feasibility of site set-up and patient recruitment, representativeness of the sample population and adequate adherence to hospital-supervised and home-supported exercise. On the basis of these positive results, progression to the fully-powered trial was authorised by the funder.

Impact of gender parity on preoperative anaemia prevalence and Patient Blood Management practice.

Anaemia is a common finding in the preoperative setting, affecting around one-third of patients for whom major surgery is programmed. Moreover, preoperative anaemia has been shown to worsen patient outcome and increase length of hospital stay and costs. In the field of preoperative anaemia correction, a recent Consensus statement suggested reviewing the classic World Health Organization (WHO) criteria in adults by aligning the haemoglobin cut-off to 13 g/dL for both genders. The aim of our study was to assess the differences in terms of prevalence, transfusion rate, transfusion trigger, and blood losses according to gender in a mixed population of surgical patients. We reviewed data of 610 consecutive patients undergoing elective major surgery at a tertiary care hospital during a 9-month period. Transfusion rate and transfusion triggers were recorded, analysed and stratified by haemoglobin class, with a particular focus on the 12.0-12.9 g/dL range. Since the anaemia threshold was redefined at 13 g/dL for both genders, its prevalence rose from 26.4 to 39.5% (161/610 vs 241/610; p<0.001) in the overall population and from 22.7 to 49.3% (68/300 vs 148/300; p<0.001) in women. Eighty women (26.7%) fell in the haemoglobin 12.0-12.9 g/dL range, and this category was the most represented among transfused women (34.0%). There was no statistical difference in transfusion triggers or overall transfusion rate between genders. Subjects of both genders were transfused at the same haemoglobin level (8.1 g/dL), but women reached the transfusion trigger after less red cell mass loss than men, i.e. 377 mL (249-472 mL) vs 528 mL (356-717 mL), respectively (p<0.001). Treatment of pre-surgical anaemia is one of the core principles of Patient Blood Management. Aligning the haemoglobin threshold between genders in the management of pre-surgical anaemia may result in a lower transfusion rate, but in an increased workload for medical staff in the preoperative phase.

Body Composition, Inflammation, and 5-Year Outcomes in Colon Cancer

Obesity, particularly visceral obesity and sarcopenia, are poor prognostic indicators in colon cancer. To explore the association between body composition profiles and 5-year colon cancer outcomes and delineate the associated underlying inflammatory processes. This multicenter translational cohort study included patients with nonmetastatic colon cancer who did not have underlying chronic inflammatory disorders and were not receiving anti-inflammatory drugs referred to tertiary cancer centers from 2009 to 2015. Preoperative acute phase proteins (white cell count, C-reactive protein, and albumin), cytokines (interleukin [IL]-1b, IL-2, IL-6, IL-10, interferon γ, and tumor necrosis factor α), vascular endothelial growth factor (VEGF), and cell surface receptor expression levels (CD11b and CD14) were measured. All patients underwent follow-up for at least 5 years. Data were analyzed in December 2020. Nonmetastatic colon cancer. The associations of body composition profiles with 5-year cancer recurrence and disease-specific mortality were analyzed using Mantel Cox log-rank test and Kaplan-Meier curves. A total of 28 patients were included (median [interquartile range] age, 67 [58-72] years; 22 [78.6%] men). Low skeletal muscle area (SMA) and high visceral to total fat ratio were associated with poor clinical and oncological outcomes, including increased 5-year recurrence (low SMA: hazard ratio [HR], 2.30 [95% CI, 1.41-2.89]; P = .04; high visceral to total fat ratio: HR, 5.78 [95% CI, 3.66-7.95]; P = .02). High visceral to total fat ratio was associated with increased 5-year disease-specific mortality (HR, 5.92 [95% CI, 4.04-8.00]; P = .02). Patients with low SMA who developed a cancer recurrence, compared with those who did not, had higher C-reactive protein (mean [SD], 31.24 [6.95] mg/dL vs 8.11 [0.58] mg/dL; P = .003), IL-6 (mean [SD], 1.93 [1.16] ng/mL vs 0.88 [0.14] ng/mL; P = .004), VEGF (mean [SD], 310.03 [122.66] ng/mL vs 176.12 [22.94] ng/mL; P = .007), and CD14 (mean [SD], 521.23 [302.02] ng/mL vs 322.07 [98.35] ng/mL; P = .03) expression and lower albumin (mean [SD], 3.8 [0.6] g/dL vs 43.50 [3.69] g/dL; P = .01), IL-2 (mean [SD], 0.45 [0.25] ng/mL vs 0.94 [0.43] ng/mL; P < .001), IL-10 (mean [SD], 8.15 [1.09] ng/mL vs 16.32 [4.43] ng/mL; P = .004), and interferon γ (mean [SD], 2.61 [1.36] ng/mL vs 14.87 [3.43] ng/mL; P = .02) levels. Patients with high visceral to total fat ratio who developed recurrence had higher levels of IL-6 (mean [SD], 5.26 [7.05] ng/mL vs 2.76 [3.11] ng/mL; P = .03) and tumor necrosis factor α (mean [SD], 5.74 [4.53] ng/mL vs 4.50 [1.99] ng/mL; P = .03). These findings suggest that low SMA and high visceral to total fat ratio were associated with worse colon cancer outcomes and with increased expression of proinflammatory cytokines and VEGF and inhibition of anti-inflammatory cytokines.

Automatic registration and precise tumour localization method for robot-assisted puncture procedure under inconsistent breath-holding conditions.

During percutaneous puncture procedure, breath holding is subjectively controlled by patients, and it is difficult to ensure consistent tumour position between the preoperative CT scanning phase and the intraoperative puncture phase. In addition, the manual registration process is time-consuming and has low accuracy. We have proposed an automatic registration method using optical markers and a tumour breath-holding position estimation model based on the support vector regression algorithm. A robot system and a tumour respiratory motion simulation platform are built to perform puncture tests under different breath-holding states. The experimental results show that automatic registration has higher accuracy than manual registration, and with the tumour breath-holding position estimation model, the targeting accuracy of puncture under inconsistent breath-holding conditions is greatly improved. The proposed automatic registration and tumour breath-holding position estimation model can improve the accuracy and efficiency of puncture under inconsistent breath-holding conditions.

Murottal Qur’an to Lower Anxiety Rate on Pre-Operative Patients

The preoperative phase was an action before surgery which was the basis for success in the next stage. In this phase, psychological disorders could occur, for example, anxiety. The feeling of anxiety that was felt by this preoperative patient might be overcome immediately, because it would hinder the future process, namely when the surgery was carried out, this was because feelings of anxiety could cause physiological changes. The purpose of this literature review was to describe the change in anxiety levels in preoperative patients after being given murottal Al-Qur'an therapy. This research design was a descriptive analysis with a literature review approach. Search for articles using 8 journal databases, namely PubMed, ScienceDirect, TaylorFrancis Online, JSTOR, SAGE Journal, Willey Online Library, Springer, and Google Scholar. Selection was carried out by assessing articles that meet the inclusion criteria with a publication range of 2015-2021, in English and Indonesian, and open access to full text pdf, while the exclusion criteria were book chapters, abstract proceedings, and posters. A total of 12 articles that met the inclusion criteria were reviewed. All articles were fully reviewed, specifically criticized and rated using the Critical Appraisal Skills Programmed instrument with 321 respondents. The results of the review showed that murottal Al-Qur'an therapy had a positive effect in lowering anxiety levels in the nursing process in preoperative patients.

Incidence and Management of Postoperativ Nausea and Vomiting: A Narrative Review

Background: Postoperative nausea and vomiting (PONV) is viewed as nausea and/or vomiting or retching that occurs in the Post- anesthesia care unit within the first 24–48 h after surgery. The incidence of these adverse reactions is between 30 and 80% following elective surgery based on the type of surgery and anesthesia, and predisposing patient risk factors. The most commonly used criteria in the perioperative assessment of the risk-score is Apfel which is a tool to evaluate PONV. The risk-score depends on Four variables: female gender, PONV history or motion sickness, postoperative opioids, and smoking status. Methods: Currently available evidence on MEDLINE, PubMed, Google scholar and Cochrane Evidence Based Medicine Reviews, in addition to the citation reviews by manual search of new anesthesia and surgical journals related to management post-operative nausea and vomiting were searched. Results: This review of recent studies showed incidence and management of post-operative nausea and vomiting and way to prevent or reduce its incidence by using monotherapy or combination antiemetic therapy, multimodal approach and by using optimal anesthetic technique for reducing baseline risk PONV. Conclusion: The causes of PONV are complex and multifaceted. Patient (gender, individual background, and medical condition); anesthesia type; and surgical procedure are all risk factors for PONV. PONV is better treated by preventing and/or minimizing PONV risk factors, as well as using prophylactic antiemetics in high-risk patients. There is no one PONV antiemetic drug or technique that is 100% appropriate for all patients at this time. If the first anti emetic is unsuccessful, a 2nd or 3rd anti emetic that targets a specific mid brain emetic receptor location may be needed. PONV prophylaxis should be considered for patients who have a low to high chance of contracting the virus, according to the scoring system. The patient may be treated with monotherapy or combination treatment of anti emetics, as well as non pharmacologic approaches and therapies to reduce baseline risk, depending on the severity of risk. A targeted multimodal solution beginning in the preoperative phase is more likely to ensure progress in the management of PONV, which increases patient care satisfaction while still being cost-effective.

Perioperative Observation Impact on Student Perception of RN Role and Safety Practices

<h3>Introduction</h3> The perioperative environment has a strong safety focus and culture. Faculty planned a project to increase student knowledge about the perioperative environment and safety practices. <h3>Identification of the problem</h3> Many schools of nursing have limited perioperative experiences (Chappy et al., 2016; Danko, 2019; Doroh & Monahan, 2016). Limited exposure may hinder student understanding of safety within the environment and may impact student interest in future employment. <h3>Purpose of the Study</h3> This study evaluated student's perception of knowledge gained and intent to apply perioperative safety concepts. <h3>Methodology</h3> Students were presented information about the preoperative, intraoperative, and postoperative areas and skills and tasks of the perioperative team with an enhanced focus on safety. Each student participated in a 10-hour experience following patients from the preoperative phase, to the operating room, postanesthesia area, and discharge from a surgery center or admission to a hospital room. After the experience, students completed a survey and reflection assignment. IRB approval was granted for a mixed method design. <h3>Results</h3> Thematic analysis revealed that the students gained knowledge and learned to value; 1) Effective teamwork within perioperative environment, 2) RN role in safe perioperative care, and 3) Quality communication by the perioperative team. Student's noted that they now feel more confident in their role of patient advocate and can support the patient when undergoing surgery or procedure. Our data also provided insight to the students' interest in perioperative nursing as a career choice. The majority of the students related appreciation for or interest in the perioperative nurse role. Of the 99 participants, only 9 stated that the environment is not for them. <h3>Discussion</h3> This study supported that a perioperative experience reinforced safety concepts and allowed students to see the perioperative nurse "in action" and provided an inside view of the perioperative environment. <h3>Conclusion</h3> A clinical observation in perioperative areas may influence the knowledge and intent to apply knowledge to their own practice as well as garner interest in the perioperative nurse role. <h3>Implications for perianesthesia nurses and future research</h3> This information could be used to support implementation of perioperative experiences in nursing programs and reinforce the role of the RN to ensure safe and quality care. The perioperative experience may also be a recruitment tool.

Effective Collaboration Towards Positive Perioperative Outcomes for the Cardiac Surgery Patient in the Preoperative Phase of Care

<h3>Background Information</h3> The pre-procedure clinic in our academic medical center provides preoperative evaluation and surgical preparation for patients. Nurses in the clinic care for complex patients and support multiple surgical specialties, including cardiac surgery. Workflows related to this subset of patients, specifically identification of blood type and antibodies, presented a particular challenge for the clinic and cardiac surgery patients were not always ready for the operating room (OR) on the day of surgery. There was a negative impact on on-time first case starts (OTFS), cardiac surgery staff utilization, and, most importantly, patient satisfaction when delays occurred the morning of surgery due to positive antibodies and the need for additional work up to prepare blood availability for surgery. <h3>Objectives of Project</h3> The project aims were to: 1) provide an efficient outpatient pre-operative 30-day blood band process in the pre-procedure evaluation clinic for the adult cardiac surgery patient as partners in care with the cardiac surgery service and 2) establish a mutually beneficial work flow between perioperative services and cardiac surgery staff to minimize downstream OR delays. <h3>Process of Implementation</h3> A consultative group guided perioperative services leadership to improve internal processes. Collaboration with the cardiac surgery clinic and patient administrative services staff was crucial for project success. The project team developed and implemented a cardiac surgery internal workflow for preoperative management and the team revised outpatient registration workflows. All patient care technicians in the pre-procedure evaluation clinic received education for preoperative 30-day blood band lab procurement and associated form storage. <h3>Statement of Successful Practice</h3> This poster illustrates that there had been an upward trend in meeting the divisional OTFS goal of ≥ 75%. As of 10/31/19, ≥ 80% of cardiac surgery first cases started on time as compared to only 55% of cases started on time in July 2019. <h3>Implications for Advancing the Practice of Perianesthesia Nursing</h3> Perinanesthesia nurses can improve the care of their patients by employing performance innovation concepts to break down barriers to ensure multidisciplinary success. By engaging multiple perioperative disciplines, providers, and members of the patient care delivery team, both patient care and organizational goals can be met. The option of 30 day blood bands is expanding to other surgical services to avoid delays the morning of surgery.

A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial

BackgroundSpinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict higher acute pain and likelihood of developing chronic postsurgical pain. Interventions targeting baseline psychosocial risk factors have potential to interrupt a negative trajectory of continued pain and poor health-related quality of life (HRQL) over time but have not yet been developed and evaluated. This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs. education-control delivered to adolescents and their parents to improve acute and chronic pain and health outcomes in adolescents undergoing spine surgery.MethodsAdolescents 12–18 years of age undergoing spinal fusion for idiopathic conditions, and their parent, will be recruited from pediatric centers across the USA, for a target complete sample of 400 dyads. Adolescents will be randomized into 4 study arms using a factorial design to SurgeryPalTM or education control during 2 phases of treatment: (1) pre-operative phase (one-month before surgery) and (2) post-operative phase (1 month after surgery). Acute pain severity and interference (primary acute outcomes) and opioid use will be assessed daily for 14 days following hospital discharge. Chronic pain severity and interference (primary acute outcomes), as well as HRQL, parent and adolescent distress, sleep quality, and opioid use/misuse (secondary outcomes), will be assessed at 3 months and 6 months post-surgery.DiscussionDemonstration of effectiveness and understanding optimal timing of perioperative intervention will enable implementation of this scalable psychosocial intervention into perioperative care. Ultimately, the goal is to improve pain outcomes and reduce reliance on opioids in adolescents after spine surgery.Trial registrationNCT04637802 ClinicalTrials.gov. Registered on November 20, 2020

Preoperative diagnostics in periampullary adenocarcinomas

Approximately 30-40% of pancreatoduodenectomies for adenocarcinomas result in nonpancreatic periampullary adenocarcinoma as the final diagnosis. Depending on the origin, adistinction is made between four different carcinomas with histomorphological subtypes. Carcinoma location and subtype are of prognostic and therapeutic relevance; however, the preoperative differentiation is often incorrect despite modern diagnostics. Overview of the current literature on the classification and preoperative diagnostics of periampullary adenocarcinomas. Aprecise knowledge of the papillary anatomy is necessary for the correct classification of diagnostic findings. Current studies demonstrate diagnostically valuable information from the anamnesis, imaging and endoscopy. In ca. 70-80% of cases acorrect diagnosis of the type of periampullary adenocarcinoma is possible on the basis of interdisciplinary diagnostics. This potentially enables acorrespondingly individualized treatment planning in the preoperative phase.

Abstract 1665: QuPath versus InForm: Digital image analysis of multiplex immunofluorescence (mIF) tumor-infiltrating lymphocyte (TIL) outcomes in an immunotherapy clinical trial

Abstract Background: mIF has emerged as a biomarker platform for characterizing TILs in breast cancer. One pitfall limiting wider application is the complex, proprietary nature of image analysis software. QuPath is an alternative, open-source platform recognized for its processing speed and ease of use. Here, we compare TIL analysis using QuPath version 0.2.3 versus InForm version 2.4, using specimens from a completed pre-operative phase Ib trial of locoregional cytokine therapy (IRX-2 regimen, Brooklyn ImmunoTherapeutics). Methods: 15 paired pre-/post-immunotherapy stage I-III early stage breast cancer specimens were analyzed using the PerkinElmer Vectra platform with a 6-plex panel: cytokeratin (CK, tumor marker), CD3 (T cells), CD8 (cytotoxic T cells), CD163 (macrophages), FoxP3 (regulatory T cells, Treg), programmed death ligand 1 (PD-L1), and DAPI nuclear counterstain. Four high-power fields (HPF) were randomly selected to represent each specimen. Images were analyzed per manufacturer instructions with InForm, and corresponding data were compared with QuPath analysis. Unmixed images were imported into QuPath and cells were segmented using a confidence threshold of DAPI stain. Cells were phenotyped using basic thresholding and random trees machine learning. Tissue was segmented using machine learning. We hypothesized that QuPath and InForm would generate correlating TIL counts data and similar cohort-level estimates of immunotherapy treatment effect. Results: We found a strong correlation in total cell count between QuPath v. InForm (R2 = 0.73, p &amp;lt; 0.001) and a moderate correlation in stromal/tumor area per HPF (R2 = 0.47, p &amp;lt; 0.001). QuPath cell phenotyping using thresholding v. random trees did not appreciably differ. However, QuPath v. InForm cell count correlations varied by cell type, with CD3+ CD8+ and CD3+ CD8- T cells strongly to moderately correlated (R2 = 0.65, p &amp;lt; 0.001 and R2 = 0.32, p &amp;lt; 0.001, respectively) and Treg and macrophage cell counts weakly correlated (R2 = 0.13, p &amp;lt; 0.001 and R2 = 0.08, p = 0.005). Continuous PD-L1 marker expression based on intensity was strongly correlated between softwares (μ: R2 = 0.97, p &amp;lt; 0.001 and σ: R2 = 0.93, p &amp;lt; 0.001). Estimated treatment effect on cell density varied by cell type (median fold change, QuPath v. Inform, CD8+: 3.1 v. 2.5; CD8-: 3.6 v. 1.5; Treg: 1.3 v. 1.1; macrophage: 3.2 v. 1.1). Outlier values were more common with QuPath in this analysis, resulting in unstable estimates of mean fold change. Conclusion: Exploratory mIF biomarker outcomes in clinical trials may depend on the method of image analysis. Further work is ongoing to evaluate and improve upon discordant results using QuPath v. InForm. These data also highlight the importance of collaborative efforts via the NIH Cancer Immune Monitoring and Analysis Centers to standardize and validate mIF methodologies across institutions. Citation Format: Benjamin M. Nikitin, Brie Chun, Isaac Kim, William L. Redmond, Katherine Sanchez, Zhaoyu Sun, Yaping Wu, David B. Page. QuPath versus InForm: Digital image analysis of multiplex immunofluorescence (mIF) tumor-infiltrating lymphocyte (TIL) outcomes in an immunotherapy clinical trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 1665.

Association of phase angle with hospital-acquired functional decline in older patients undergoing cardiovascular surgery

ObjectiveThe aim of this study was to examine whether preoperative phase angle (PhA) measured by bioelectrical impedance analysis was associated with a hospital-acquired functional decline in older patients undergoing cardiovascular surgery. MethodsThis was an observational study of prospectively collected data of 114 patients (>65 y of age) with cardiovascular disease who underwent elective cardiovascular surgery between September 2019 and August 2020. Patients were classified into tertiles based on PhA levels. Factors associated with the occurrence of hospital-acquired functional decline (postoperative recovery to preoperative physical function was not possible) were analyzed using univariate and multivariate analyses. ResultsPatients in the low PhA group were significantly older than those in the middle and high PhA groups; were predominantly women; had higher New York Heart Association cardiovascular and EuroSCORE severity scores; and had significantly lower levels of body mass index, Geriatric Nutritional Risk Index, hemoglobin, and albumin. There was a significant correlation between PhA and nutrition and physical function. The incidence of hospital-acquired functional decline occurred in 26.3% of all patients, with a significantly higher incidence in patients in the low PhA group. Multivariate analysis showed that PhA was extracted as a factor for the hospital-acquired functional decline in all the models. ConclusionsPhA was associated with hospital-acquired functional decline in older patients undergoing cardiovascular surgery. PhA is likely to be a comprehensive indicator of physical health that indicates nutritional status, physical function, and geriatric syndrome (frailty/sarcopenia), and is an important predictor of hospital-acquired functional decline in this group of older patients.

Intraoperative recordings of electromyogenic responses from the human stapedius muscle

Following surgical implantation of a cochlear implant, the external processor must be programmed individually, which is typically achieved by behavioral measurements, with the user indicating the perceived loudness between the threshold and the maximum comfort levels (MCLs). However, the stapedius reflex measurement could be used instead, as the basis for programming the fitting maps. The electrically evoked stapedius reflex threshold is known to have a high correlation with the MCLs and thus is used as an objective tool to determine the MCL, especially in children and non-cooperative patients. Previous studies demonstrated that the electromyogenic (EMG) activity of the stapedius muscle could be measured to determine stapedius reflex responses. The objective of this study was to demonstrate that intraoperative EMG recordings from the stapedius muscle could be performed with an EMG recording electrode designed for chronical implantation.Ten adult subjects with single sided deafness (SSD) participated in this study. The study was split up into a pre-, intra- and postoperative phase. In the preoperative phase the subjects were screened for the presence of the acoustic stapedius reflex by using a standard tympanometer in the ear to be implanted, while the contralateral ear was stimulated acoustically. During the intraoperative phase an EMG recording electrode was placed in the stapedius muscle and EMG responses were recorded during acoustical and electrical stimulation. The surgical procedure consisted of two interconnected procedures: A classical surgical approach for cochlear implantation with two additional surgical steps, and the temporary placement of an EMG recording electrode in the stapedius muscle made through an opening in the pyramidal eminence, allowing EMG recordings. The postoperative phase was used to evaluate the preservation of the stapedius reflex postoperatively at 1- and 6-months with contralateral acoustic and ipsilateral electrical stimulation.The EMG recording electrode could successfully be placed in the stapedius muscle in all subjects and was able to reliably record EMG signals from the stapedius muscle elicited by acoustic and electrical stimulation. Overall, EMG recordings were obtained intraoperatively in all subjects tested (8 out of 8 subjects). Contralateral acoustic stapedius reflexes were obtained in 6 out of 8 subjects and ipsilateral electrical stapedius reflex in 7 out of 8 subjects. In the postoperative phase, the preservation of the postoperative reflex was observed in 6 out of 10 subjects 1-month after surgery and in 8 out of 10 subjects 6-months after surgery.The study showed that intraoperative EMG recordings from the stapedius muscle can be performed with an EMG recording electrode designed for chronical implantation. The minimally invasive procedure is promising; in particular with regard to the future perspective of measurements in the long-term with an integrated closed-loop self-fitting system.

The Effectiveness of a Preoperative Lifestyle-Based Weight Loss Program on Postoperative Outcomes in Bariatric Patients: A Secondary Data Analysis

ObjectivesTo assess the effectiveness of a program to implement long-term diet, lifestyle, and behavioral changes in bariatric surgery patients. MethodsSixteen subjects (age = 45.9 ± 11.5 years; BMI = 46.1 ± 8.3 kg/m2) participated in a comprehensive 36-week lifestyle-based program to promote weight loss before and after bariatric surgery. During the preoperative phase, baseline data on body measurements, food frequency, meal patterns and timings, miscellaneous lifestyle habits, and perceived level of self-efficacy regarding eating behaviors were collected, after which subjects underwent an intensive 24-week lifestyle program. At the end of the intervention, the same outcomes were assessed again before surgery was performed. Following surgery, the subjects completed the same program for 12 weeks, with additional data (as above) being collected at the beginning and at the end of the 12 weeks. Intra- and inter-phase comparative analyses were conducted on body measurements (weight, BMI, and waist circumference) and lifestyle habits (changes in food frequency, meal patterns and timings, miscellaneous lifestyle habits, and perceived level of self-efficacy) using Wilcoxon Signed Ranks Test. ResultsThere was a statistically significant reduction in both preoperative (P = 0.016) and postoperative weight (P = 0.003). A reduction in waist circumference was also observed post-surgery (P = 0.027). Overall, participants lost an average of 28% of their baseline body weight (P < 0.000) and 19% of their baseline waist circumference (P < 0.000). Over the course of the program, there was a significant improvement in some diet and lifestyle-related habits, such as decreased fast-food consumption and screen time (P = 0.004 and 0.047, respectively). Self-monitoring and overall self-efficacy also improved by the end of the program (P = 0.002 and P = 0.003, respectively). ConclusionsThe present findings indicate that a comprehensive lifestyle-based weight loss program is beneficial for further reduction in weight and waist circumference among bariatric patients. Additionally, this program facilitated significant improvements in diet and lifestyle-related factors, as well as self-monitoring and perceived self-efficacy. Funding SourcesThis study was funded by Loma Linda University School of Allied Health Professions, Department of Nutrition and Dietetics.

The concept and use of the neoadjuvant rectal score as a composite endpoint in rectal cancer.

There is no universally accepted instrument to use as a validated surrogate endpoint for overall survival in phase 2 and phase 3 multimodal rectal cancer trials using chemoradiotherapy. Efforts are hampered by the inaccuracy of clinical TNM staging, the variability of indications for neoadjuvant treatment, and diverse definitions of tumour regression grade. Pathological complete response is commonly used, but fails to capture information from the majority of patients. The neoadjuvant rectal score categorises response and downstaging from the entire trial population to identify whether or not a novel treatment group in a chemoradiation trial is superior by predicting overall survival outcomes. Additionally, the neoadjuvant rectal score assesses the difference between initial clinical and pathological T stage and the presence or absence of nodal involvement after treatment. The neoadjuvant rectal score has been conceptually, but incompletely, statistically validated by two independent trial datasets. However, a fundamental weakness of the score is that no preoperative phase 3 trials in locally advanced rectal cancer in the past 20 years have provided a significant benefit in overall survival to statistically validate the neoadjuvant rectal score as a surrogate endpoint for overall survival. We review the robustness, practical value, applicability, generalisability, advantages, and disadvantages of the neoadjuvant rectal score as a surrogate endpoint for overall survival and recommend how this score could be improved and be acceptable as a standard endpoint in studies investigating neoadjuvant chemotherapy and chemoradiation in patients with rectal cancer.

Preliminary efficacy and safety of perioperative treatment of camrelizumab combined with apatinib in resectable hepatocellular carcinoma (HCC): A prospective phase II study.

4082 Background: Although there is no standard perioperative treatment for resectable HCC characterized with high recurrence rate, the strategy of immunotherapy combined with targeted agents is promising in neoadjuvant/adjuvant therapy in various tumors. Methods: In this perspective, single-arm, exploratory phase II trial (NCT04297202), eligible patients (pts) were systemic treatment-naive resectable HCC in intermediate/advanced stage. Preoperative combined treatment of anti-PD-1 antibody camrelizumab (200 mg q2w for 3 cycles) and VEGFR-2 inhibitor apatinib (250 mg qd for 21 days) was started on day 1 cycle 1. On the 7th day after the 3 cycles, radiological imaging was assessed to confirm whether to conduct the hepatectomy. Four weeks after the surgery, combined treatment (camrelizumab 200 mg q3w, apatinib 250 mg qd, 3 weeks per cycle) was resumed for the postoperative 8 cycles. The primary endpoint was major pathologic response (MPR) defined as 50%-99% tumor necrosis in resected tissue. Gene expression profiles (GEPs) using immune-related RNA with pre-treatment specimens were analyzed. The association between immune signatures and pathological response (responders (R) vs. non-responders (NR)) was assessed. Results: A total of 20 pts were enrolled between Dec 5, 2019 and Jan 27, 2021, with a median follow-up of 5.7 months (range 0.7-9.0). All pts were ECOG PS 0-1 and Child-Pugh class A. There were 85% pts with hepatitis B and 10% with hepatitis C, and 55% in BCLC stage B, 35% in stage C and 10% in stage A. In preoperative phase, with 2 withdraw of informed consent form, partial response was reached in 3/18 (16.7%) and 8/18 (44.4%) pts per RECIST 1.1 and mRECIST, respectively, while disease progression was found in 1/18 (5.6%) pts impossible for hepatectomy, which made the resection rate 17/18 (94.4%). After the surgery, one was found to be combined hepatocellular-cholangiocarcinoma by histopathological examination and failed to proceed the postoperative study. The rates of MPR and pathological complete response (pCR) were 5/17 (29.4%) and 1/17 (5.9%), respectively. The preliminary analysis of GEPs (R:NR = 3:4) revealed higher levels of chemokines ( CXCL10 and CXCL11) in responders and higher MS4A4A (marker gene of macrophages ) in non-responders. The most common TEAEs included hypertension (95%), proteinuria (40%), AST elevation (40%), and platelet count decrease (45%). Grade 3 TEAEs were hypertension (20%), rash (10%), and platelet count decrease (10%). No grade 4/5 TEAEs was observed. The most common surgical complications were ALT and AST increase each with the incidence of 70% (all grades) and 45% (grade ≥ 3). Conclusions: This study preliminarily demonstrated that the perioperative treatment of camrelizumab combined with apatinib improved the MPR and pCR with managable safety in intermediate/advanced resectable HCC. Clinical trial information: NCT04297202.

Short term cognitive function after sevoflurane anesthesia in patients suspect to obstructive sleep apnea syndrome: an observational study

BackgroundThe obstructive sleep apnea syndrome (OSAS) is characterized by intermittent cerebral hypoxia which can cause cognitive alterations. Likewise, hypoxia induced neurocognitive deficits are detectable after general anesthesia using volatile anesthetics.The objective of this study was to evaluate the association between a moderate to high risk patients of OSAS and postoperative cognitive dysfunction after volatile anesthesia.MethodsIn this single center prospective, observational study between May 2013 and September 2013, 46 patients aged 55 to 80 years with an estimated hospital stay of at least 3 days undergoing surgery were enrolled. Patients were screened using the STOP-BANG test with score of 3 or higher indicating moderate to high risk of OSAS. The cognitive function was assessed using a neuropsychological assessment battery, including the DemTect test for cognitive impairment among other tests e.g. SKT memory, the day before surgery and within 2 days after extubation.ResultsTwenty-three of the 46 analyzed patients were identified with a moderate to high risk of OSAS. When comparing post- to preoperative phase a significant better performance for the SKT was found for both groups (p < 0.001). While the moderate to high risk group scores increased postoperative in the DemTect test, they decreased in the low risk group (p < 0.003). When comparing the changes between groups, the moderate to high risk patients showed significant better test result for DemTect testing after anaesthesia. This effect remained robust when adjusting for potential confounding variables using a two-factor ANOVA.ConclusionCompared to low risk, a moderate to high risk of OSAS based on the STOP-BANG score was associated with improved postoperative cognitive function measured by the DemTect test.Trial registrationThe study was approved by the local Ethics committee (Ethikkommission der Medizinischen Fakultät der Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany) (reference number: 87_12 B) on 19.04.2012.