scholarly journals Obesity is Not Associated with Perioperative Adverse Events in Patients Undergoing Complex Revision Surgery for the Thoracolumbar Spine

2021 ◽  
Author(s):  
Takashi Hirase ◽  
Jeremiah F. Ling ◽  
Varan Haghshenas ◽  
David Dong ◽  
Darrell S. Hanson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Spine Surgery ◽  
Revision Surgery ◽  
Multivariable Analysis ◽  
Thoracolumbar Spine ◽  
Psoas Muscle ◽  
Perioperative Outcomes ◽  
Multivariable Logistic Regression Model ◽  
Level Of Evidence ◽  
Significant Difference

Abstract Study Design: Retrospective cohort studyObjective: This study sought to determine the relationship between obesity and perioperative adverse events (AEs) with patients undergoing complex revision thoracolumbar spine surgery while controlling for psoas muscle index (PMI) as a confounding variable.Methods: Between May 2016 and February 2020, a retrospective analysis of individuals undergoing complex revision surgery of the thoracolumbar spine was performed at a single institution. Obesity was defined as BMI ≥ 30.0 kg/m2. PMI < 500 mm2/m2 for males and < 412 mm2/m2 for females were used to define sarcopenia. A Spine Surgical Invasiveness Index (SSII) > 10 was used to define complex revision surgery. A multivariable logistic regression model was used to ascertain the effects of sarcopenia, obesity, age, and gender on the likelihood of the occurrence of any AE.Results: The study included 114 patients. 54 patients were in the obese cohort and 60 patients in the non-obese cohort. There was not a significant difference in perioperative outcomes of both the obese and non-obese patients. Multivariable analysis demonstrated that sarcopenic individuals had a significantly higher likelihood for an AE than non-sarcopenic individuals (OR: 7.53, 95% CI: 3.05-18.60). Obesity did not have a significant effect in predicting AEs.Conclusions: Obesity is not associated with perioperative AEs, 30-day readmission rates, 30-day re-operation rates, rate of discharge to a facility, or post-operative length of stay (LOS) among patients undergoing complex revision thoracolumbar spine surgery.Level of Evidence: III

scholarly journals Psoas Muscle Index as a Predictor of Perioperative Outcomes in Geriatric Patients Undergoing Spine Surgery

2022 ◽  
pp. 219256822110726
Author(s):  
Mark N. Pernik ◽  
William H. Hicks ◽  
Omar S. Akbik ◽  
Madelina L. Nguyen ◽  
Ivan Luu ◽  
...  
Keyword(s):  
Spine Surgery ◽  
Revision Surgery ◽  
Geriatric Patients ◽  
Psoas Muscle ◽  
Perioperative Outcomes ◽  
Discharge Disposition ◽  
Postoperative Blood Transfusion ◽  
Baseline Creatinine ◽  
Fourth Quartile

Study Design Single-center retrospective study. Objective The objective of this study was to evaluate the association of psoas muscle mass defined sarcopenia with perioperative outcomes in geriatric patients undergoing elective spine surgery. Methods We included geriatric patients undergoing thoracolumbar spinal surgery. Total psoas surface area (TPA) was measured on preoperative axial computerized tomography or magnetic resonance imaging at the L3 vertebra and normalized to the L3 vertebral body area. Patients were divided into quartiles by normalized TPA, and the fourth quartile (Q4) was compared to quartiles 1–3 (Q1-3). Outcomes included perioperative transfusions, length of stay (LOS), delirium, pseudoarthrosis, readmission, discharge disposition, revision surgery, and mortality. Results Of the patients who met inclusion criteria (n = 196), the average age was 73.4 y, with 48 patients in Q4 and 148 patients in Q1-3. Q4 normalized TPA cut-off was <1.05. Differences in Q4 preoperative characteristics included significantly lower body mass index, baseline creatinine, and a greater proportion of females (Table 1). Q4 patients received significantly more postoperative red blood cell and platelet transfusions and had longer ICU LOS ( P < .05; Table 2). There was no difference in intraoperative transfusion volumes, delirium, initiation of walking, discharge disposition, readmission, pseudoarthrosis, or revision surgery (Tables 2 and 3). Mortality during follow-up was higher in Q4 but was not statistically significant ( P = .075). Conclusion Preoperative TPA in geriatric patients undergoing elective spine surgery is associated with increased need for intensive care and postoperative blood transfusion. Preoperative normalized TPA is a convenient measurement and could be included in geriatric preoperative risk assessment algorithms.

Impact of Physician Training Level on Neonatal Tracheal Intubation Success Rates and Adverse Events: A Report from National Emergency Airway Registry for Neonates (NEAR4NEOS)

Neonatology ◽  
2021 ◽  
pp. 1-9
Author(s):  
Lindsay Johnston ◽  
Taylor Sawyer ◽  
Anne Ades ◽  
Ahmed Moussa ◽  
Jeanne Zenge ◽  
...  
Keyword(s):  
Tracheal Intubation ◽  
Adverse Events ◽  
Multivariable Analysis ◽  
Estimating Equation ◽  
Oxygen Desaturation ◽  
Physician Training ◽  
Training Level ◽  
Success Rates ◽  
Emergency Airway ◽  
Significant Difference

<b><i>Introduction:</i></b> Neonatal tracheal intubation (TI) outcomes have been assessed by role, but training level may impact TI success and safety. Effect of physician training level (PTL) on the first-attempt success, adverse TI-associated events (TIAEs), and oxygen desaturation was assessed. <b><i>Methods:</i></b> Prospective cohort study in 11 international NEAR4NEOS sites between October 2014 and December 2017. Primary TIs performed by pediatric/neonatal physicians were included. Univariable analysis evaluated association between PTL, patient/practice characteristics, and outcomes. Multivariable analysis with generalized estimating equation assessed for independent association between PTL and outcomes (first-attempt success, TIAEs, and oxygen desaturation ≥20%; attending as reference). <b><i>Results:</i></b> Of 2,608 primary TIs, 1,298 were first attempted by pediatric/neonatal physicians. PTL was associated with patient age, weight, comorbidities, TI indication, difficult airway history, premedication, and device. First-attempt success rate differed across PTL (resident 23%, fellow 53%, and attending 60%; <i>p</i> &#x3c; 0.001). There was no statistically significant difference in TIAEs (resident 22%, fellow 20%, and attending 25%; <i>p</i> = 0.34). Desaturation occurred more frequently with residents (60%), compared to fellows and attendings (46 and 53%; <i>p</i> &#x3c; 0.001). In multivariable analysis, adjusted odds ratio of the first-attempt success was 0.18 (95% CI: 0.11–0.30) for residents and 0.80 (95% CI: 0.51–1.24) for fellows. PTL was not independently associated with adjusted odds of TIAEs or severe oxygen desaturation. <b><i>Conclusion:</i></b> Higher PTL was associated with increased first-attempt success but not TIAE/oxygen desaturation. Identifying strategies to decrease adverse events during neonatal TI remains critical.

scholarly journals The Effectiveness and Safety of Thunder Fire Moxibustion for Treating Allergic Rhinitis: A PRISMA Compliant Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Ting Yuan ◽  
Jun Xiong ◽  
Jun Yang ◽  
Xue Wang ◽  
Yunfeng Jiang ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Assessment Tool ◽  
Total Effective Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Cochrane Library ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Significant Difference

Background. Allergic rhinitis (AR) is a noninfectious inflammatory disease caused by allergic individuals exposed to allergens. Western medicine therapy for treating AR causes obvious adverse events, while thunder fire moxibustion (TFM) is known as a safe and effective treatment for AR. Therefore, we conducted this meta-analysis to evaluate the effectiveness and safety of TFM for treating AR. Methods. PubMed, Web of Science, Embase, the Cochrane Library, CNKI, WanFang, VIP, and CBM from inception to April 5, 2020, were searched without any language restriction. Reviewers identified studies, extracted data, and assessed the quality, independently. The primary outcomes were the total effective rate and the TNSS. The secondary outcomes included TNNSS, RQLQ, VAS, serum IgE, IgA, or IgG level, and adverse events. Randomized controlled trials (RCTs) were collected; methodological quality was evaluated using the Cochrane risk of bias assessment tool (RoB), and the level of evidence was rated using the GRADE approach. Meta-analysis was performed using the RevMan5.3.0 software. Results. A total of 18 RCTs were included, including 1600 patients. The results of this meta-analysis showed a statistically significant effect in a total effective rate of T = TFM (RR = 1.07; 95% CI [1.03, 1.12]; P=0.45; I2 = 0%) and T = TFM + other treatments (RR = 1.18; 95% CI [1.11, 1.25]; P=0.03; I2 = 53%). In addition, TFM intervention also showed significant difference in total symptom score (T = TFM + other treatments) (MD = −1.42; 95% CI [−1.55, −1.29]; P=0.03; I2 = 60%) in patients with AR. Conclusion. Existing evidence shows that TFM is safe and effective for AR. Due to the universal low quality of the eligible trials and low evidence level, we should draw our conclusions with caution. Therefore, clinical researchers should carry out more large-sample, multicentre, high-quality randomized controlled clinical trials in the future to verify the clinical efficacy of TFM in treating AR.

scholarly journals Perioperative outcomes and adverse events of minimally invasive versus open posterior lumbar fusion: meta-analysis and systematic review

2016 ◽  
Vol 24 (3) ◽  
pp. 416-427 ◽  
Author(s):  
Christina L. Goldstein ◽  
Kevin Macwan ◽  
Kala Sundararajan ◽  
Y. Raja Rampersaud
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Adverse Events ◽  
Minimally Invasive ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Perioperative Outcomes ◽  
Estimated Blood Loss ◽  
Significant Difference ◽  
Patient Reported

OBJECT The objective of this study was to determine the clinical comparative effectiveness and adverse event rates of posterior minimally invasive surgery (MIS) compared with open transforaminal or posterior lumbar interbody fusion (TLIF/PLIF). METHODS A systematic review of the Medline, EMBASE, PubMed, Web of Science, and Cochrane databases was performed. A hand search of reference lists was conducted. Studies were reviewed by 2 independent assessors to identify randomized controlled trials (RCTs) or comparative cohort studies including at least 10 patients undergoing MIS or open TLIF/PLIF for degenerative lumbar spinal disorders and reporting at least 1 of the following: clinical outcome measure, perioperative clinical or process measure, radiographic outcome, or adverse events. Study quality was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) protocol. When appropriate, a meta-analysis of outcomes data was conducted. RESULTS The systematic review and reference list search identified 3301 articles, with 26 meeting study inclusion criteria. All studies, including 1 RCT, were of low or very low quality. No significant difference regarding age, sex, surgical levels, or diagnosis was identified between the 2 cohorts (856 patients in the MIS cohort, 806 patients in the open cohort). The meta-analysis revealed changes in the perioperative outcomes of mean estimated blood loss, time to ambulation, and length of stay favoring an MIS approach by 260 ml (p < 0.00001), 3.5 days (p = 0.0006), and 2.9 days (p < 0.00001), respectively. Operative time was not significantly different between the surgical techniques (p = 0.78). There was no significant difference in surgical adverse events (p = 0.97), but MIS cases were significantly less likely to experience medical adverse events (risk ratio [MIS vs open] = 0.39, 95% confidence interval 0.23–0.69, p = 0.001). No difference in nonunion (p = 0.97) or reoperation rates (p = 0.97) was observed. Mean Oswestry Disability Index scores were slightly better in the patients undergoing MIS (n = 346) versus open TLIF/PLIF (n = 346) at a median follow-up time of 24 months (mean difference [MIS – open] = 3.32, p = 0.001). CONCLUSIONS The result of this quantitative systematic review of clinical comparative effectiveness research examining MIS versus open TLIF/PLIF for degenerative lumbar pathology suggests equipoise in patient-reported clinical outcomes. Furthermore, a meta-analysis of adverse event data suggests equivalent rates of surgical complications with lower rates of medical complications in patients undergoing minimally invasive TLIF/PLIF compared with open surgery. The quality of the current comparative evidence is low to very low, with significant inherent bias.

scholarly journals The Risk Factors for Perioperative Serum Albumin Variation in Pediatric Patients Undergoing Major Gastroenterology Surgery

2021 ◽  
Vol 7 ◽  
Author(s):  
Qingshuang Liu ◽  
Kai Gao ◽  
Chao Zheng ◽  
Chunbao Guo
Keyword(s):  
Risk Factors ◽  
Serum Albumin ◽  
Pediatric Patients ◽  
Operating Time ◽  
Multivariable Analysis ◽  
Postoperative Outcome ◽  
Perioperative Outcomes ◽  
Multivariable Logistic Regression Model ◽  
Perioperative Morbidity ◽  
Charcot’S Triad

Background: The albumin, a negative acute-phase protein, is important for perioperative morbidity, even in patients with normal preoperative levels. This study intend to determine the perioperative factors related with the postoperative reduction in serum albumin (ΔALB) and its influence on perioperative outcome in a pediatric general surgical cohort.Methods: This single-center retrospective review included 939 pediatric patients who underwent major gastroenterology surgery from August 2010 to August 2019. The patients were dichotomized into a high ΔALB group (≥14.6%) and a low ΔALB group (&lt;14.6%) based on the mean value of ΔALB (14.6%). the independent risk factors for ΔALB, were explored using the propensity score matching to minimize potential selection bias and subjected to method multivariable logistic regression model. Furthermore, in 366 matched patients, the influences of operating time on perioperative outcomes were analyzed.Results: Among the 996 patients reviewed, 939 patient records were enrolled in the final analysis. Controlling for other factors, multivariable analysis showed that a high CRP on POD 3 or 4 [odds ratio (OR) = 2.36 (95% CI, 1.51–3.86); p = 0.007], a longer operating time [OR = 1.18 (95% CI, 1.00–1.53); p = 0.014), and the presence of Charcot's triad [OR = 1.73 (95% CI, 1.05–2.83); p = 0.031] were factors that predicted a high ΔALB level. A high ΔALB level was also related with gastrointestinal functional recovery delay, reflected by the postoperative defecation (p = 0.013) and bowel movement (p = 0.019) delay and the high occurrence of postoperative complications (16.1 vs. 10.9%, OR, 1.57; 95% CI, 1.02–2.41, P = 0.0026).Conclusions: The high ΔALB level was correlated with postoperative outcome. To obtain a safe recovery and discharge after a major abdominal operation, the above risk factors for ΔALB could be addressed in the perioperative period.

scholarly journals Delayed Ejaculation After Lumbar Spine Surgery: A Claims Database Analysis

2020 ◽  
pp. 219256822096243
Author(s):  
Hriday P. Bhambhvani ◽  
Alex M. Kasman ◽  
Chiyuan A. Zhang ◽  
Serena S. Hu ◽  
Michael L. Eisenberg
Keyword(s):  
Lumbar Spine ◽  
Spine Surgery ◽  
Interbody Fusion ◽  
Lumbar Fusion ◽  
Multivariable Analysis ◽  
Thoracolumbar Spine ◽  
Lumbar Spine Surgery ◽  
Lumbar Interbody Fusion ◽  
Delayed Ejaculation ◽  
Institutional Experience

Study Design: Retrospective cohort. Objectives: Delayed ejaculation (DE) is a distressing condition characterized by a notable delay in ejaculation or complete inability to achieve ejaculation, and there are no existing reports of DE following lumbar spine surgery. Inspired by our institutional experience, we sought to assess national rates of DE following surgery of the lumbar spine. Methods: We queried the Optum De-identified Clinformatics Database for adult men undergoing surgery of the lumbar spine between 2003 and 2017. The primary outcome was the development of DE within 2 years of surgery. Multivariable logistic regression was performed to identify factors associated with the development of DE. Results: We identified 117 918 men who underwent 162 646 lumbar spine surgeries, including anterior lumbar interbody fusion (ALIF), posterior lumbar fusion (PLF), and more. The overall incidence of DE was 0.09%, with the highest rate among ALIF surgeries at 0.13%. In multivariable analysis, the odds of developing DE did not vary between anterior/lateral lumbar interbody fusion, PLF, and other spine surgeries. A history of tobacco smoking (OR = 1.47, 95% CI 1.00-2.16, P = .05) and obesity (OR = 1.56, 95% CI 1.00-2.44, P = .05) were associated with development of DE. Conclusions: DE is a rare but distressing complication of thoracolumbar spine surgery, and patients should be queried for relevant symptoms at postoperative visits when indicated.

Female-to-Male Gender-Confirming Drainless Mastectomy May Be Safe in Obese Males

2019 ◽  
Vol 40 (3) ◽  
pp. NP85-NP93
Author(s):  
Eric M Pittelkow ◽  
Stephen P Duquette ◽  
Farrah Rhamani ◽  
Corianne Rogers ◽  
Sidhbh Gallagher
Keyword(s):  
Gender Dysphoria ◽  
Medical Condition ◽  
Perioperative Outcomes ◽  
Morbidly Obese ◽  
Level Of Evidence ◽  
Transgender People ◽  
Super Obese ◽  
Significant Difference ◽  
Transgender Men

Abstract Background Gender dysphoria is a medical condition associated with suicidality. Transgender men who have undergone female-to-male (FTM) chest reconstruction report higher quality of life and reduced gender dysphoria. It has been reported that transgender men are at higher risk of obesity. Objectives The objective of this study was to compare perioperative outcomes and complications between different classes of obesity in FTM transgender patients who underwent chest masculoplasty. Methods A retrospective review of 145 consecutive patients who underwent mastectomy with free nipple graft was conducted. Postoperative outcomes and complications were collected. Patients were divided into nonobese (body mass index [BMI] &lt;30 kg/m2), obese (BMI 30-39.9 kg/m2), morbidly obese (BMI 40-49.9 kg/m2), and super obese (BMI &gt;50 kg/m2) groups. Results Sixty-six of the 145 patients were not obese, 52 were obese, 22 were morbidly obese, and 5 were super obese. There was a statistically significant increase in amount of breast tissue resected between each of the 4 groups (866.8 g vs 1672.4 g vs 3157.1 g vs 4827.6 g; P ≤ 0.0005) as BMI increased, respectively. There was a significant difference in operative time between the nonobese and obese groups (128.7 vs 134.6 vs 150.5 vs 171 minutes; P = 0.026). A significant increase in postoperative infections was observed between the morbidly obese, super obese, and the nonobese group (P = 0.048). Conclusions Chest wall reconstruction in FTM and nonbinary transgender people is important in relieving gender dysphoria. Postoperative complications were not significantly increased in obese patients (30-39.9 kg/m2). Delaying surgery for weight loss may not be necessary unless patients are morbidly obese. Level of Evidence: 4

scholarly journals Operative and nonoperative adverse events in the management of traumatic fractures of the thoracolumbar spine: a systematic review

2014 ◽  
Vol 37 (1) ◽  
pp. E8 ◽  
Author(s):  
George M. Ghobrial ◽  
Christopher M. Maulucci ◽  
Mitchell Maltenfort ◽  
Richard T. Dalyai ◽  
Alexander R. Vaccaro ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Length Of Stay ◽  
Adverse Events ◽  
Nonoperative Management ◽  
Thoracolumbar Spine ◽  
Complication Rates ◽  
Medline Search ◽  
Significant Difference ◽  
The Mean ◽  
Nonoperative Group

Object Thoracolumbar spine injuries are commonly encountered in patients with trauma, accounting for almost 90% of all spinal fractures. Thoracolumbar burst fractures comprise a high percentage of these traumatic fractures (45%), and approximately half of the patients with this injury pattern are neurologically intact. However, a debate over complication rates associated with operative versus nonoperative management of various thoracolumbar fracture morphologies is ongoing, particularly concerning those patients presenting without a neurological deficit. Methods A MEDLINE search for pertinent literature published between 1966 and December 2013 was conducted by 2 authors (G.G. and R.D.), who used 2 broad search terms to maximize the initial pool of manuscripts for screening. These terms were “operative lumbar spine adverse events” and “nonoperative lumbar spine adverse events.” Results In an advanced MEDLINE search of the term “operative lumbar spine adverse events” on January 8, 2014, 1459 results were obtained. In a search of “nonoperative lumbar spine adverse events,” 150 results were obtained. After a review of all abstracts for relevance to traumatic thoracolumbar spinal injuries, 62 abstracts were reviewed for the “operative” group and 21 abstracts were reviewed for the “nonoperative” group. A total of 14 manuscripts that met inclusion criteria for the operative group and 5 manuscripts that met criteria for the nonoperative group were included. There were a total of 919 and 436 patients in the operative and nonoperative treatment groups, respectively. There were no statistically significant differences between the groups with respect to age, sex, and length of stay. The mean ages were 43.17 years in the operative and 34.68 years in the nonoperative groups. The majority of patients in both groups were Frankel Grade E (342 and 319 in operative and nonoperative groups, respectively). Among the studies that reported the data, the mean length of stay was 14 days in the operative group and 20.75 in the nonoperative group. The incidence of all complications in the operative and nonoperative groups was 300 (32.6%) and 21 (4.8%), respectively (p = 0.1065). There was no significant difference between the 2 groups with respect to the incidence of pulmonary, thromboembolic, cardiac, and gastrointestinal complications. However, the incidence of infections (pneumonia, urinary tract infection, wound infection, and sepsis) was significantly higher in the operative group (p = 0.000875). The incidence of instrumentation failure and need for revision surgery was 4.35% (40 of 919), a significant morbidity, and an event unique to the operative category (p = 0.00396). Conclusions Due to the limited number of high-quality studies, conclusions related to complication rates of operative and nonoperative management of thoracolumbar traumatic injuries cannot be definitively made. Further prospective, randomized studies of operative versus nonoperative management of thoracolumbar and lumbar spine trauma, with standardized definitions of complications and matched patient cohorts, will aid in properly defining the risk-benefit ratio of surgery for thoracolumbar spine fractures.

scholarly journals Improving recovery after elective degenerative spine surgery: 5-year experience with an enhanced recovery after surgery (ERAS) protocol

2019 ◽  
Vol 46 (4) ◽  
pp. E7 ◽  
Author(s):  
Victor E. Staartjes ◽  
Marlies P. de Wispelaere ◽  
Marc L. Schröder
Keyword(s):  
Adverse Events ◽  
Hospital Stay ◽  
Spine Surgery ◽  
Surgical Procedures ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Perioperative Outcomes ◽  
Degenerative Spine ◽  
Concomitant Decrease ◽  
Eras Protocol

OBJECTIVEEnhanced recovery after surgery (ERAS) has led to a paradigm shift in various surgical specialties. Its application can result in substantial benefits in perioperative healthcare utilization through preoperative physical and mental patient optimization and modulation of the recovery process. Still, ERAS remains relatively new to spine surgery. The authors report their 5-year experience, focusing on ERAS application to a broad population of patients with degenerative spine conditions undergoing elective surgical procedures, including anterior lumbar interbody fusion (ALIF).METHODSA multimodal ERAS protocol was applied between November 2013 and October 2018. The authors analyze hospital stay, perioperative outcomes, readmissions, and adverse events obtained from a prospective institutional registry. Elective tubular microdiscectomy and mini-open decompression as well as minimally invasive (MI) anterior or posterior fusion cases were included. Their institutional ERAS protocol contains 22 pre-, intra-, and postoperative elements, including preoperative patient counseling, MI techniques, early mobilization and oral intake, minimal postoperative restrictions, and regular audits.RESULTSA total of 2592 consecutive patients were included, with 199 (8%) undergoing fusion. The mean hospital stay was 1.1 ± 1.2 days, with 20 (0.8%) 30-day and 36 (1.4%) 60-day readmissions. Ninety-four percent of patients were discharged after a maximum 1-night hospital stay. Over the 5-year period, a clear trend toward a higher proportion of patients discharged home after a 1-night stay was observed (p < 0.001), with a concomitant decrease in adverse events in the overall cohort (p = 0.025) and without increase in readmissions. For fusion procedures, the rate of 1-night hospital stays increased from 26% to 85% (p < 0.001). Similarly, the average length of hospital stay decreased steadily from 2.4 ± 1.2 days to 1.5 ± 0.3 days (p < 0.001), with a notable concomitant decrease in variance, resulting in an estimated reduction in nursing costs of 46.8%.CONCLUSIONSApplication of an ERAS protocol over 5 years to a diverse population of patients undergoing surgical procedures, including ALIF, for treatment of degenerative spine conditions was safe and effective, without increase in readmissions. The data from this large case series stress the importance of the multidisciplinary, iterative improvement process to overcome the learning curve associated with ERAS implementation, and the importance of a dedicated perioperative care team. Prospective trials are needed to evaluate spinal ERAS on a higher level of evidence.

The effect of neoadjuvant chemotherapy with gemcitabine and S-1 for resectable pancreatic cancer (randomized phase II/III trial; Prep-02/JSAP-05).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4126-4126 ◽  
Author(s):  
Sohei Satoi ◽  
Michiaki Unno ◽  
Fuyuhiko Motoi ◽  
Yutaka Matsuyama ◽  
Ippei Matsumoto ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Adverse Events ◽  
Operation Time ◽  
Ductal Adenocarcinoma ◽  
Perioperative Outcomes ◽  
Rank Test ◽  
Nodal Metastases ◽  
Resection Rate ◽  
Significant Difference

4126 Background: Despite recent progress of adjuvant chemotherapy for resected pancreatic ductal adenocarcinoma (PDAC), its survival remains limited. We conducted a randomized controlled trial to compare neoadjuvant chemotherapy (NAC) with upfront surgery (UP-S) for patients with resectable PDAC. Methods: Patients with resectable PDAC, all confirmed cytologically or histologically were enrolled. Patients received 2 cycles of gemcitabine and S-1 regimen (GS) followed by surgery (NAC) or UP-S after randomization (1:1). Patients in both arms received adjuvant chemotherapy using S-1 for 6 months after surgical resection. The primary endpoint was overall survival (OS); secondary endpoints included adverse events, resection rate, recurrence-free survival, residual tumor status, nodal metastases, and tumor marker kinetics. Results: A total 362 patients were randomly assigned to NAC-GS (n=182) or UP-S (n=180) for 3 years (2013-16). The median OS was 36.7 months in NAC-GS and 26.6 months in UP-S; HR 0.72 (p=0.015, stratified log-rank test) at 2.5 year after final enrollment. Crude resection rate for NAC and UP-S were 77%, 72% respectively. There was no operative mortality in both groups. Although G3/4 adverse events were observed frequently (73%) during NAC, no significant difference for both groups was observed for perioperative outcomes including blood loss, operation time, R0 resection rate and post-operative morbidity. Significant decrease of pathological nodal metastases in NAC was noted compared to those in UP-S by pathological evaluation for resected patients(p<0.01). Although significant decrease of viable tumor cells was observed in primary tumor after NAC compared to UP-S (p<0.01), Evans IIb or more was found in only 14 % of resected patients in NAC. Hepatic recurrence after surgery was significantly reduced in NAC (30.0%) compared to UP-S (47.5%) in observed period. Conclusions: The strategy of NAC showed significant longer survival compared to that of UP-S with acceptable feasibility. The effect of NAC might imply the control of subdiagnostic liver metastases before surgery for resectable PDAC. Clinical trial information: UMIN000009634.

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