Influence of Pre- and Intraoperative Local Anaesthetic in Strabismus Surgery under General Anaesthesia in Adults.

BACKGROUND: As studies have shown a reduction in the occurrence of the oculocardiac reflex with the addition of local anaesthesia, we changed our care regime accordingly a few years ago. To promote and establish better patient care, we retrospectively analysed the files of our patients who underwent strabismus surgery from 2013 to 2021 in order to compare strabismus surgery under general anaesthesia with and without local anaesthetics in a routine clinical setting. PATIENTS AND METHODS: Data from 238 adult patients who had undergone strabismus surgery could be extracted from the files: G1: n = 102, only general anaesthesia; G2: n = 136, preoperative application of tetracaine eye drops and intraoperative subtenon lidocaine/levobupivacaine in addition to general anaesthesia. We compared the two groups in regard to the frequency of oculocardiac reflex, the amount of atropine needed to treat, as well as the amount of antiemetic and analgesic medication given, and time spent in the recovery room. RESULTS: Mean age of G1 was 50 years and 52 years in G2. There was no significant difference between the kind of surgeries (recessions/resections), the number of patients who had undergone a reoperation, or the duration of the operations. Adding local anaesthetics resulted in significantly less occurrence of oculocardiac reflex (p = 0.009), a reduction in the need for atropine, analgesic, or antiemetic medication, as well as reduced time in the recovery room. CONCLUSION: As this increases patient safety and comfort and is cost-effective (less time in the recovery room), we recommend adding perioperative local anaesthesia to strabismus surgery performed under general anaesthesia.

Endoscopic transcanal facial nerve decompression in Bell's palsy: A pilot study.

PURPOSE: To explore the surgical effects of endoscopic facial nerve decompression in Bell's palsy. MATERIALS AND METHODS: This retrospective study included 15 patients with Bell's palsy. All had grade VI (House-Brackmann grading system) complete unilateral facial paralysis before surgery and a >95% reduction in amplitude on electroneurography testing compared to the unaffected side. Their MRI results indicated perineural edema in the geniculate ganglion area. Endoscopic decompression surgery was performed soon after they presented at our hospital. The time between onset of facial paralysis and surgery ranged from 25 to 93 days. All patients had no relevant surgical history or ear diseases. RESULTS: At 1-year follow-up, 13 of the 15 (87%) patients had recovered to normal or near-normal facial function (House-Brackmann grade I-II), and all patients had reached House-Brackmann grade III or lower facial function. No obvious air-bone gap or sensorineural hearing loss occurred after surgery, and there were no severe complications or synkinesis. CONCLUSIONS: Endoscopic transcanal facial nerve decompression provides a less traumatic and improved exposure of the geniculate ganglion, and may also help prevent permanent severe facial sequela. Results of intraoperative facial nerve stimulation may be related to the length of time required for recovery. The optimal time of surgery after onset of paralysis needs to be investigated further, to identify a post-drug surgical therapy which may be more acceptable for patients. Patients' response to conservative treatments should be assessed as soon as possible so as not to delay surgery.

Effects of Intraoperative Auditory Stimulation on Pain and Agitation on Awakening After Pediatric Adenotonsillectomy: A Randomized Clinical Trial.

Importance: Severe pain on awakening (POA) and emergence delirium (ED) are common following pediatric adenotonsillectomy. Effective preventive interventions are lacking. Objective: To determine the effects of intraoperative auditory stimulation on reduction of POA and ED after pediatric adenotonsillectomy. Design, Setting, and Participants: Single-center, double-blinded, 4-armed, randomized clinical trial of children undergoing adenotonsillectomy from March 2018 to May 2019 at a tertiary care pediatric referral center. Interventions: Children were randomized to 1 of the following groups: auditory stimulation with music, auditory stimulation with noise, ambient noise insulation with masking earplugs, and a control group receiving no intervention. Ear inserts were placed in the operating room once general anesthesia was administered. Stimulation parameters were based on the preoperative audiological evaluation and the appropriate fitting of the transduction system, including ambient noise level monitoring. Main Outcomes and Measures: The primary outcome was POA levels measured on 10-point scales according to age-appropriate validated tools. The secondary outcome was ED levels assessed according to the Pediatric Anesthesia Emergence Delirium 20-point scale. Results: A total of 104 consecutive healthy children (median [interquartile range] age at surgery, 5.0 [3.8-6.4] years) were included in the analysis. Music had a large effect size on POA (0.63; 98% CI, 0.43-0.84) and a medium effect size on ED (0.47; 98% CI, 0.21-0.75), while noise had a medium effect size on POA (0.47; 98% CI, 0.22-0.73) and a large effect size on ED (0.63; 98% CI, 0.44-0.85) compared with controls. The earplugs group showed a small effect size on POA and ED. Considering a clinically meaningful threshold of greater than 4 for POA and 10 or greater for ED at dichotomized analysis, a large effect size was achieved by music (1.39; odds ratio [OR], 0.08; 98% CI, 0.02-0.29; and 0.84; OR, 0.22; 98% CI, 0.06-0.75, respectively) and noise (0.97; OR, 0.17; 98% CI, 0.05-0.6; and 1.48; OR, 0.07; 98% CI, 0.02-0.26, respectively), while earplugs resulted in a small effect size. Conclusions and Relevance: In this randomized clinical trial, children undergoing adenotonsillectomy who received intraoperative auditory stimulation demonstrated a clinically meaningful decrease in POA and ED in the immediate postoperative period. Further research is needed to assess whether intraoperative auditory stimulation may decrease POA and ED in children undergoing other types of surgical procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT04112979.

Excellent Prognosis of Patients With Invasive Lung Adenocarcinomas During Surgery Misdiagnosed as Atypical Adenomatous Hyperplasia, Adenocarcinoma In Situ, or Minimally Invasive Adenocarcinoma by Frozen Section.

BACKGROUND: Our previous study revealed that intraoperative frozen section (FS) analysis could differentiate invasive lung adenocarcinoma (LUAD) accurately from preinvasive lesions. However, few articles have analyzed the clinical impact of FS errors such as underestimation of invasive adenocarcinomas (IACs), and whether complementary therapy is needed remains controversial. RESEARCH QUESTION: What is the prognosis of patients undergoing limited resection for invasive LUAD misdiagnosed as atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), or minimally invasive adenocarcinoma (MIA) by intraoperative FS analysis? STUDY DESIGN AND METHODS: From 2012 through 2018, data on 3031 patients undergoing sublobar resection of AAH, AIS, or MIA diagnosed by FS analysis were collected. The concordance rate between FS analysis and final pathologic results was evaluated. To assess the clinical significance of a discrepancy between FS and final pathologic results, patients with final pathologic results of IAC were identified for prognostic evaluation. RESULTS: When AAH, AIS, and MIA were classified together as a group, the overall concordance rate between FS and final pathologic results was 93.7%, and 192 patients (6.3%) received an upgraded diagnosis from the final pathologic results. Misdiagnosed IACs consisted of 94 patients (48.9%) with lepidic-predominant adenocarcinoma, 77 patients (40.1%) with acinar predominant adenocarcinoma, 19 patients (9.9%) with papillary predominant adenocarcinoma, one patient with solid predominant adenocarcinoma, and one patient with invasive mucinous adenocarcinoma. Among these patients, no positive N1 or N2 lymph node findings were observed. Moreover, the 5-year recurrence-free survival was still 100%, although the final pathologic results turned out to be IAC. INTERPRETATION: Patients undergoing limited resection of invasive LUAD misdiagnosed as AAH, AIS, or MIA by FS analysis showed excellent prognoses. Sublobar resection guided by FS diagnosis would be adequate for these underestimated cases of invasive LUAD.

Effect of magnesium supplementation on emergence delirium and postoperative pain in children undergoing strabismus surgery: a prospective randomised controlled study.

BACKGROUND: The benefits of intraoperative magnesium supplementation have been reported. In this prospective, randomized study, the effects of magnesium supplementation during general anaesthesia on emergence delirium and postoperative pain in children were evaluated. METHODS: A total of 66 children aged 2 to 5 years who underwent strabismus surgery were assigned to the magnesium or to the control group. Preoperative anxiety was assessed using the modified Yale Preoperative Anxiety Scale. After anaesthesia induction, the magnesium group received an initial loading dose of 30 mg/kg magnesium sulphate over 10 min and, then, continuous infusion of 10 mg/kg per h until 10 min before the end of the surgery. The control group received an equal volume of normal saline via the same regimen. The Paediatric Anaesthesia Emergence Delirium (PAED) score, pain score, and respiratory events were assessed at the postanaesthetic care unit. RESULTS: Data obtained from 65 children were analyzed. The PAED and pain scores of the two groups did not differ significantly. There were 26 of 33 (78.8%) and 27 of 32 (84.4%) children with emergence delirium in the control and the magnesium groups, respectively (odds ratio 0.69, 95% CI 0.19-2.44; p = 0.561). The preoperative anxiety score was not significantly correlated with the PAED score. The incidence of respiratory events during the emergence period did not differ significantly between the two groups. CONCLUSIONS: Magnesium supplementation during anaesthesia had no significant effects on the incidence of emergence delirium or postoperative pain in children undergoing strabismus surgery. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03132701 ). Prospectively registered May 8, 2017.

A Tenon's capsule/bulbar conjunctiva interface biomimetic to model fibrosis and local drug delivery.

Glaucoma filtration surgery is one of the most effective methods for lowering intraocular pressure in glaucoma. The surgery efficiently reduces intra-ocular pressure but the most common cause of failure is scarring at the incision site. This occurs in the conjunctiva/Tenon's capsule layer overlying the scleral coat of the eye. Currently used antimetabolite treatments to prevent post-surgical scarring are non-selective and are associated with potentially blinding side effects. Developing new treatments to target scarring requires both a better understanding of wound healing and scarring in the conjunctiva, and new means of delivering anti-scarring drugs locally and sustainably. By combining plastic compression of collagen gels with a soft collagen-based layer, we have developed a physiologically relevant model of the sub-epithelial bulbar conjunctiva/Tenon's capsule interface, which allows a more holistic approach to the understanding of subconjunctival tissue behaviour and local drug delivery. The biomimetic tissue hosts both primary human conjunctival fibroblasts and an immune component in the form of macrophages, morphologically and structurally mimicking the mechanical proprieties and contraction kinetics of ex vivo porcine conjunctiva. We show that our model is suitable for the screening of drugs targeting scarring and/or inflammation, and amenable to the study of local drug delivery devices that can be inserted in between the two layers of the biomimetic. We propose that this multicellular-bilayer engineered tissue will be useful to study complex biological aspects of scarring and fibrosis, including the role of inflammation, with potentially significant implications for the management of scarring following glaucoma filtration surgery and other anterior ocular segment scarring conditions. Crucially, it uniquely allows the evaluation of new means of local drug delivery within a physiologically relevant tissue mimetic, mimicking intraoperative drug delivery in vivo.

Ultra-Mini-Percutaneous Nephrolithotomy for the Treatment of Upper Urinary Tract Stones Sized between 10-20 mm in Children Younger Than 8 Years Old.

PURPOSE: With the invention of miniature devices, it has been advised to apply less aggressive methods for the management of upper urinary tract stones, especially in children. In the recent years, ultra-mini percutaneous nephrolithotomy (UMP) has been used for the treatment of upper urinary tract stones in order to perform surgeries with less complications and more acceptable outcomes. Results reported from different medical centers have been promising. MATERIALS AND METHODS: Twenty-two children aged less than 8 years old with upper urinary stones sized between 10-20 mm underwent UMP. Inclusion criteria was solitary unilateral kidney stone, stone size between 10-20 mm, normal renal function tests, absence of any congenital malformations, and history of previous ESWL failure. Data including age, sex, side of kidney involvement, size of stone, location of stone, duration of surgery, duration of hospitalization, stone composition, need for blood transfusion, damage to adjacent organs, postoperative fever, septicemia after surgery, need for narcotics, further need for a complementary method, stone-free rate, pre and post-operative hemoglobin levels, and urinary leakage from the access tract were extracted from patients' medical files and were recorded. RESULTS: The mean age (± standard deviation) of children was 5.22 (±1.57) years. Fourteen (63.6%) patients were male. Fifteen (68.2%) renal stones were located in the right kidney, and 82% of patients had pelvis stones. 13 (59%) patients' stones were composed of calcium oxalate. Stone-free rate was 95.5%. In none of the cases urinary leakage, septicemia after surgery, injury to adjacent organs, and need for blood transfusions was reported. CONCLUSION: Ultra-mini percutaneous nephrolithotomy is an efficient and safe method for treating urinary stones sized between 10-20 mm in children.

The role of intra-operative cell salvage in patient blood management for revision hip arthroplasty: a prospective cohort study.

Cell salvage is an important component of blood management in patients undergoing revision hip arthroplasty surgery. However concerns regarding efficacy and patient selection remain. The aims of this study were to describe intra-operative blood loss, cell salvage re-infusion volumes and red blood cell transfusion rates for revision hip procedures and to identify factors associated with the ability to salvage sufficient blood intra-operatively to permit processing and re-infusion. Data were collected from a prospective cohort of 664 consecutive patients undergoing revision hip surgery at a single tertiary centre from 31 March 2015 to 1 April 2018. Indications for revision surgery were aseptic (n = 393 (59%)) fracture (n = 160 (24%)) and infection (n = 111 (17%)). Salvaged blood was processed and re-infused when blood loss exceeded 500 ml. Mean (SD) intra-operative blood loss was 1038 (778) ml across all procedures. Salvaged blood was re-infused in 505 of 664 (76%) patients. Mean (SD) re-infusion volume was 253 (169) ml. In total, 246 of 664 (37%) patients received an allogeneic red blood cell transfusion within 72 h of surgery. Patients undergoing femoral component revision only (OR (95%CI) 0.41 (0.23-0.73)) or acetabular component revision only (0.53 (0.32-0.87)) were less likely to generate sufficient blood salvage volume for re-infusion compared with revision of both components. Compared with aseptic indications, patients undergoing revision surgery for infection (1.87 (1.04-3.36)) or fracture (4.43 (2.30-8.55)) were more likely to generate sufficient blood salvage volume for re-infusion. Our data suggest that cell salvage is efficacious in this population. Cases where the indication is infection or fracture and where both femoral and acetabular components are to be revised should be prioritised.

Impact of Intraoperative Cell Salvage on Blood Coagulation Factor Concentrations in Patients Undergoing Cardiac Surgery.

BACKGROUND: Cardiothoracic surgery is associated with major blood loss and allogeneic transfusion of red blood cell concentrates. To minimize allogeneic red blood cell (RBC) transfusion, intraoperative cell salvage has been effectively used for years. The objective of this study was to evaluate the impact of cell salvage on blood coagulation factors. METHODS: We enrolled 30 patients scheduled for cardiac surgery in a prospective single-center observational cohort study at an academic hospital. Blood samples from the cell salvage system were obtained from both the reservoir and the processed red blood cell concentrate. Coagulation factors, fibrinogen, antithrombin and von Willebrand activity, and antigen were assessed before and after cell salvage. Statistical analysis was performed using Wilcoxon matched-pairs signed rank test. RESULTS: Our results revealed a significant decrease of fibrinogen (P < .001), coagulation factors II (P = .004), factors VII, X, and XIII (P < .001), and all other measured coagulation factor concentrations/activities in the processed red blood cell concentrate, when compared to the concentrations/activities of the reservoir. CONCLUSIONS: The results of the present study revealed a significant reduction of coagulation factor concentrations/activities by the washing process. Therefore, physicians need to consider adequate management of coagulation in patients with major blood loss and the need of large volumes of RBC transfusion.

Comparison of the Wide-Awake Approach and Conventional Approach in Extensor Indicis Proprius-to-Extensor Pollicis Longus Tendon Transfer for Chronic Extensor Pollicis Longus Rupture.

BACKGROUND: The wide-awake approach enables surgeons to perform optimal tensioning of a transferred tendon intraoperatively. The authors hypothesized that the extensor indicis proprius-to-extensor pollicis longus tendon transfer using the wide-awake approach would yield better results than conventional surgery. METHODS: A retrospective analysis was performed of the prospectively collected data of 29 consecutive patients who underwent extensor indicis proprius-to-extensor pollicis longus tendon transfer. Patients were treated with the wide-awake approach (group A, n = 11) and conventional surgery under general anesthesia (group B, n = 18). The groups were compared retrospectively for thumb interphalangeal and metacarpophalangeal joint motion, grip and pinch strength, specific extensor indicis proprius-to-extensor pollicis longus evaluation method (SEEM), and Disabilities of the Arm, Shoulder and Hand questionnaire score at 6 weeks and 2, 4, 6, and 12 months postoperatively. RESULTS: Group A showed significantly better interphalangeal joint flexion and total arc of motion at 6 weeks and 2, 4, and 6 months, and significantly better metacarpophalangeal joint flexion and total arc of motion at all time points. Interphalangeal and metacarpophalangeal joint extension showed no difference at all time points. Group A showed significantly better specific extensor indicis proprius-to-extensor pollicis longus evaluation method scores at 2 and 4 months, and Disabilities of the Arm, Shoulder and Hand questionnaire scores at 4, 6, and 12 months. Grip and pinch strength showed no difference at all time points. The complication rate and duration until return to work were not different between groups. CONCLUSION: Compared with the conventional approach, the wide-awake approach showed significantly better results in the thumb's range of motion and functional outcomes, especially in the early postoperative periods. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

General versus local anesthesia for percutaneous radiofrequency ablation of hepatocellular carcinoma at unusual regions.

AIMS: The aim of this study is to compare the efficacy and safety of percutaneous radiofrequency ablation (RFA) under general anesthesia or local anesthesia plus intraoperative analgesia in the treatment of hepatocellular carcinoma (HCC) at unusual regions. SUBJECTS AND METHODS: From July 2012 to October 2019, 83 consecutive patients with 107 HCC lesions were treated with interventional radiology therapy. The lesions were located at some unusual regions such as diaphragmatic surface, hepatic hilum, hepatic subcapsular region, tissues near inferior vena cava, and tissues near the colon. General anesthesia was applied in 57 cases (general anesthesia group) and local anesthesia plus intraoperative analgesia was used in 26 cases (local anesthesia group). All patients were treated with transcatheter arterial chemoembolization, followed immediately by RFA. The rate of tumor inactivation, time used for placing RF needles to the scheduled sites, pain score, and complications were analyzed. STATISTICAL ANALYSIS USED: All continuous variables were tested for the normal/nonnormal distribution by Kolmogorov-Smirnov test. The t-test was used to analyze the normal distribution variables; the Mann-Whitney U-test was used to measure nonnormal distribution variables; and the Chi-square test for categorical variables. P < 0.05 was considered statistically significant. RESULTS: The treatments were successful in all patients, including 51 cases of complete response (CR) and 6 cases of partial response (PR) in the general anesthesia group and 18 cases of CR and 8 cases of PR in the local anesthesia group (P = 0.049). The time used for placing the needles to the scheduled sites was 1-5 min (mean 2 min) in the general anesthesia group and 2-9 min (mean 4 min) in the local analgesia group (P < 0.001). The pain scores ranged from 0 to 2 points (mean 1 point) in the general anesthesia group and 2-9 points (mean 5 points) in the local anesthesia group (P < 0.001). With regard to complications, seven cases had pneumothorax and four cases had slight hepatic subcapsular hemorrhage in the general anesthesia group and four cases of pneumothorax and three cases of slight hepatic subcapsular hemorrhage in the local anesthesia group, and the difference was not statistically significant between the two groups (P = 0.715). CONCLUSIONS: For HCC located at unusual regions, general anesthesia is superior to local anesthesia plus intraoperative analgesia in percutaneous RFA in reducing the difficulty of the procedure and improving the safety of RFA.

Effectiveness of Intraoperative Laser Acupuncture Combined with Antiemetic Drugs for Prevention of Postoperative Nausea and Vomiting.

Introduction: Postoperative nausea and vomiting (PONV) are frequent in patients undergoing laparoscopic cholecystectomy. The aim of this study is to evaluate the effectiveness of intraoperative laser acupuncture stimulation of Pericardium 6 (PC6) and Large Intestine 4 (LI4) acupoints combined with antiemetic drug prophylaxis on PONV. Methods: A total of 88 patients, scheduled for laparoscopic cholecystectomy, were assigned into 2 groups. Group I received bilateral laser acupuncture on PC6 and LI4 acupoints after induction of anesthesia and also received antiemetic drug (metoclopramide) prophylaxis. Patients in Group II received only antiemetic drug prophylaxis. Nausea and vomiting frequencies and need for rescue antiemetic drug (ondansetron) were recorded after extubation, at 30th minute at recovery room and at 6th hour at ward. Results: The incidence of nausea and rescue antiemetic drug need was higher at postoperative 6th hour in Group II. Vomiting was not different in groups at any time. Conclusion: Intraoperative laser acupuncture stimulation of PC6 and LI4 acupoints combined with antiemetic drug prophylaxis decreases nausea and rescue antiemetic drug need in late postoperative period in patients undergoing laparoscopic cholecystectomy.

Music Interventions in Pediatric Surgery (The Music Under Surgery In Children Study): A Randomized Clinical Trial.

BACKGROUND: Perioperative music interventions have been shown to reduce anxiety and pain in adults. This inexpensive, easily applicable intervention could be of benefit to children as well. Our objective was to determine the effects of music interventions on distress, anxiety, and postoperative pain in infants undergoing surgery. METHODS: The Music Under Surgery In Children study was designed as a parallel, single-blind, randomized controlled trial with an a priori formulated hypothesis. Data were collected between August 2015 and October 2016 in a single tertiary care children's hospital. There was a 24-hour follow-up with blind primary outcome assessment. A random sample of 432 eligible 0-3 years of age infants admitted for orchidopexy, hypospadias, or inguinal hernia repair receiving general anesthesia and caudal block were asked for participation. Subjects were assigned to a preoperative music intervention, pre- and intraoperative music intervention, or no music intervention (control) via random allocation using a computer-generated list with the use of opaque envelopes. The main outcome measure was the postoperative level of distress assessed with the COMFORT-Behavior scale, which is an observational scale; furthermore, preoperative level of distress, preoperative anxiety, and physiological measurements such as heart rate (HR) and blood pressure were measured. The trial was registered at the Dutch Trial Register, number NTR5402 (www.trialregister.nl). RESULTS: One hundred ninety-five infants with median age 6.9 months (interquartile range, 3.3-11.1) were randomized, 178 of whom were included in the primary analysis. A nonsignificant difference in COMFORT-Behavior scale scores between the pre- and intraoperative music intervention group and control group at 4 hours after surgery was found (mean difference, -1.22; 95% CI, 2.60-0.17; P = .085). Additional analysis showed weak nonsignificant evidence for an interaction effect between music exposure and COMFORT-Behavior score at baseline (P = .027 with a Bonferroni-adjusted significance level of .025). General linear modeling showed a statistically significantly reduced HR after the preoperative music intervention in the holding area in the combined preoperative music intervention and intraoperative music intervention group compared to the control group (P = .003). The differences in HR among the 3 study arms at all time points were not statistically significant (P = .069). CONCLUSIONS: Music interventions do not seem to benefit all young infants undergoing surgery. The potential benefits of music interventions in the preoperative period and in more distressed children warrant further exploration.

Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study.

INTRODUCTION: Pancreatic cancer is a devastating disease with an exceptionally poor prognosis. Complete resection of the primary tumour followed by adjuvant chemotherapy is the current standard treatment for patients with resectable disease and the only curative treatment option. However, long-term survival remains rare. Tumour cell dissemination due to manipulation during surgery may increase the rate of future metastases and local recurrence, and perioperative chemotherapy might diminish local, distant and circulating minimal residual disease. Yet, safety and feasibility of systemic chemotherapeutic treatments during pancreatic cancer resection have to be evaluated in a first instance. METHODS AND ANALYSIS: This is a prospective, single-centre phase I/II feasibility study to investigate the safety and tolerability of a combination of intraoperative chemotherapy and surgical resection in pancreatic cancer. Forty patients with locally confined or borderline resectable pancreatic cancer, meeting all proposed criteria will be included. Participants will receive 400 mg/m2 calcium folinate over 2 hours and 2000 mg/m2 5-fluorouracil over 48 hours, started on the day before pancreatic surgery and thus continuing during surgery. Participants will be followed until 60 days after surgery. The primary endpoint is the 30-day overall complication rate according to the Clavien-Dindo classification. Secondary endpoints comprise toxicity and treatment associated complications. Patients receiving perioperative chemotherapy will be compared with a propensity score matched contemporary control group of 70 patients with pancreatic cancer receiving the standard treatment. This trial also contains an ancillary translational study to analyse disseminated tumour cells and effects of pharmacological interventions in pancreatic cancer. ETHICS AND DISSEMINATION: CombiCaRe has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4042787) and the Medical Ethics Committee of Heidelberg University (reference number AFmo-269/2018). The results of this trial will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00015766).

Intraoperative Autologous Blood Donation Leads to Fewer Transfusions in Cardiac Surgery.

BACKGROUND: Blood conservation with antifibrinolytics, topical hemostatics, and strict transfusion triggers are becoming commonplace in cardiac surgery. The aim of this study was to evaluate the effect of a blood conservation protocol centering on standardized intraoperative autologous blood donation (IAD) use in cardiac surgery. METHODS: We reviewed charts of patients who underwent cardiac surgery at our hospital over an 8-year period to analyze transfusion tendencies before and after a new blood conservation policy was implemented. Propensity score matching was used to account for population differences in preoperative and perioperative covariates. RESULTS: Over an 8-year period (January 2009 to December 2017) 1002 patients were studied. Three hundred fifty-two patients before the new blood conservation policy (group 1) were compared with 650 patients after the change (group 2). Fewer group 2 patients required blood transfusions during their hospital stay (78% vs 61%, P < .001), were transfused fewer units (2.8 vs 1.81 units, P < .001), and experienced a shorter length of stay (8.02 vs 7.28 days, P = .012). Propensity score-matched cohorts revealed reductions in any complication (29.5% vs 18.8%, P = .007), fewer postoperative transfusions (70.1% vs 50.9%, P < .001), and a lower transfusion volume (1.82 vs 1.21 units, P = .002) associated with IAD without any associated change in mortality. CONCLUSIONS: IAD use is associated with reduced transfusions in cardiac surgery and may be considered a complementary aspect of blood conservation. Our experience suggests it may be applied with few limitations. A causal relationship between IAD and outcomes should be established with prospective studies.

The use and protective effects of transcutaneous electrical acupoint stimulation during abdominal surgery: study protocol for a multicenter randomized parallel controlled trial.

BACKGROUND: Acupuncture-balanced anesthesia has been found to offer protective benefits. Electrical stimulation at certain acupoints can potentially promote perioperative gastrointestinal function recovery. The purpose of this study is to explore the effects of acupuncture-balanced anesthesia on the postoperative recovery of gastrointestinal function, on anesthesia strategies for abdominal surgery, on postoperative pain treatment, and on any associated complications or alterations in immune function. We further seek to verify the protective effects of transcutaneous electrical acupoint stimulation (TEAS), to explore possible underlying neuroimmune-endocrine mechanisms, and to thereby develop an optimized acupuncture-balanced anesthesia strategy suitable for abdominal surgery. Together, these findings will provide a scientific basis for the clinical utilization of acupuncture-balanced anesthesia in the context of abdominal surgery. METHODS/DESIGN: This study is a multicenter, large-sample, randomized placebo-controlled trial. All subjects will be patients undergoing elective gastric or colorectal surgery. In Part 1, these patients will be stratified according to surgical site (gastric or colorectal), and randomly divided into four groups based on different perioperative interventions: Con group, which will undergo sham TEAS before, during, and after surgery; T1 group, which will receive TEAS during the preoperative and intraoperative periods, and sham TEAS during the postoperative period; T2 group, which will receive TEAS during the preoperative period, sham TEAS during the intraoperative period, and TEAS during the postoperative period; and T3 group, which will receive TEAS before, during, and after operation. Part 2 of this study will focus solely on colorectal surgery patients. All patients will receive TEAS during the preoperative and intraoperative periods, and they will be randomized into four groups according to different postoperative treatments: Con' group, which will not receive TEAS; T1' group, which will receive sham TEAS; T2' group, which will receive 5-Hz TEAS; and T3' group, which will receive 100-Hz TEAS. Venous blood (5 ml) will be used to measure immunological and inflammatory indexes both at the preoperative stage prior to TEAS and 4-5 days after operation. The primary outcome will be the time to first bowel sounds after surgery. Secondary outcomes will include gastrointestinal functional recovery, analgesic efficacy during the postoperative period, acupuncture-balanced anesthesia efficacy, postoperative nausea and vomiting, and postoperative complications. DISCUSSION: This study is designed to investigate the clinical value of TEAS during various perioperative periods in those undergoing abdominal surgery, with the overall goal of evaluating the clinical value and advantages of acupuncture-balanced anesthesia, and of providing new strategies for improving patient prognoses. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-TRC-14004435. Registered on 26 March 2014.