Research Information Service Identifier Research Articles

Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial.

Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies. The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuum-assisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years. This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients. ClinicalTrials.gov Identifier: NCT05505357. Registered on August 17, 2022. Clinical Research Information Service Identifier: KCT0007638. Registered on July 25, 2022.

Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System.

Although a single-lead electrocardiogram (ECG) patch may provide advantages for detecting arrhythmias in outpatient settings owing to user convenience, its comparative effectiveness for real-time telemonitoring in inpatient settings remains unclear. We aimed to compare a novel telemonitoring system using a single-lead ECG patch with a conventional telemonitoring system in an inpatient setting. This was a single-center, prospective cohort study. Patients admitted to the cardiology unit for arrhythmia treatment who required a wireless ECG telemonitoring system were enrolled. A single-lead ECG patch and conventional telemetry were applied simultaneously in hospitalized patients for over 24 hours for real-time telemonitoring. The basic ECG parameters, arrhythmia episodes, and signal loss or noise were compared between the 2 systems. Eighty participants (mean age 62±10 years, 76.3% male) were enrolled. The three most common indications for ECG telemonitoring were atrial fibrillation (66.3%), sick sinus syndrome (12.5%), and atrioventricular block (10.0%). The intra-class correlation coefficients for detecting the number of total beats, atrial and ventricular premature complexes, maximal, average, and minimal heart rates, and pauses were all over 0.9 with p values for reliability <0.001. Compared to a conventional system, a novel system demonstrated significantly lower signal noise (median 0.3% [0.1-1.6%] vs. 2.4% [1.4-3.7%], p<0.001) and fewer episodes of signal loss (median 22 [2-53] vs. 64 [22-112] episodes, p=0.002). The novel telemonitoring system using a single-lead ECG patch offers performance comparable to that of a conventional system while significantly reducing signal loss and noise. Clinical Research Information Service Identifier: KCT0008176.

Lymphadenectomy in clinically early epithelial ovarian cancer and survival analysis (LILAC): a Gynecologic Oncology Research Investigators Collaboration (GORILLA-3002) retrospective study.

This study aimed to evaluate the therapeutic role of lymphadenectomy in patients surgically treated for clinically early-stage epithelial ovarian cancer (EOC). This retrospective, multicenter study included patients with clinically early-stage EOC based on preoperative abdominal-pelvic computed tomography or magnetic resonance imaging findings between 2007 and 2021. Oncologic outcomes and perioperative complications were compared between the lymphadenectomy and non-lymphadenectomy groups. Independent prognostic factors were determined using Cox regression analysis. Disease-free survival (DFS) was the primary outcome. Overall survival (OS) and perioperative outcomes were the secondary outcomes. In total, 586 patients (lymphadenectomy group, n=453 [77.3%]; non-lymphadenectomy groups, n=133 [22.7%]) were eligible. After surgical staging, upstaging was identified based on the presence of lymph node metastasis in 14 (3.1%) of 453 patients. No significant difference was found in the 5-year DFS (88.9% vs. 83.4%, p=0.203) and 5-year OS (97.2% vs. 97.7%, p=0.895) between the two groups. Using multivariable analysis, lymphadenectomy was not significantly associated with DFS or OS. However, using subgroup analysis, the lymphadenectomy group with serous histology had higher 5-year DFS rates than did the non-lymphadenectomy group (86.5% vs. 74.4%, p=0.048; adjusted hazard ratio=0.281; 95% confidence interval=0.107-0.735; p=0.010). The lymphadenectomy group had longer operating time (p<0.001), higher estimated blood loss (p<0.001), and higher perioperative complication rate (p=0.004) than did the non-lymphadenectomy group. In patients with clinically early-stage EOC with serous histology, lymphadenectomy was associated with survival benefits. Considering its potential harm, lymphadenectomy should be performed according to histologic subtype and subsequent chemotherapy in patients with clinically early-stage EOC. Clinical Research Information Service Identifier: KCT0007309.

Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Human Epidermal Growth Factor 2-Positive/Triple-Negative Breast Cancer Patients With Excellent Response.

The Avoid Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy (ASLAN) trial aims to demonstrate the oncologic safety of omitting axillary surgery in patients with excellent response after neoadjuvant chemotherapy (NACT) for early human epidermal growth factor 2 (HER2)-positive (+)/triple-negative breast cancer (TNBC) who have undergone breast-conserving surgery (BCS) and adjuvant radiotherapy. The ASLAN trial will provide crucial information that could change the procedure in highly selected patients undergoing axillary surgery after NACT. ASLAN is a prospective, multicenter, and single-arm surgical trial. The recruitment will be conducted among five tertiary care hospitals in the Republic of Korea. The total number of patients to be recruited will be 178, and we plan to complete patient enrollment by December 2023. The enrollment is considered among patients with HER2+ breast cancer (BC) or TNBC at clinical stage T1-3N0-1M0 who are expected to achieve breast pathological complete response (BpCR) based on a combination of radiologic imaging and physical examination after NACT. BCS was performed on eligible patients. After BCS, patients who showed BpCR were enrolled with the omission of sentinel lymph node biopsy (SLNB). The primary study endpoint upon completion of this trial is 5-year recurrence-free survival, and the secondary endpoints include the 5-year ipsilateral breast tumor recurrence interval, 5-year ipsilateral axillary recurrence interval, 5-year distant metastasis-free survival, 5-year BC-specific survival, 5-year overall survival, 5-year contralateral BC-free survival, re-operation rate according to breast biopsy after NACT, adverse events within 5 years, and quality of life. Several clinical trials are currently underway to determine whether SLNB can be omitted after NACT in patients with HER2+ BC or TNBC that are expected to achieve pathologic complete response. The ASLAN trial is expected to provide valuable clues regarding the feasibility of omitting axillary surgery in highly selected patients. ClinicalTrials.gov Identifier: NCT04993625. Registered on August 6, 2021. Clinical Research Information Service Identifier: KCT0006371. Registered on July 22, 2021.

Effect of Self-treatment of Recurrent Benign Paroxysmal Positional Vertigo

Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo with frequent recurrences. To determine the efficacy of a web-based diagnosis and treatment of BPPV when it recurs in patients with confirmed and treated BPPV. This randomized, controlled, parallel-group, double-blind trial took place in multiple referral-based university hospitals in South Korea between July 2017 and February 2020. Of 728 patients (age ≥20 years) with diagnosed and treated BPPV, 585 were enrolled after excluding 143 who declined participation, could not use the internet, or had spinal problems, multicanal BPPV, or cognitive dysfunction. Patients were followed up for recurrence at least for 2 years until February 2022. Patients were randomly assigned (1:1) to the treatment or control group. The patients in the treatment group completed a questionnaire for diagnosis and received a video clip for self-administration of canalith repositioning maneuver (CRM) according to the type of BPPV diagnosed when they experienced positional vertigo again. Patients in the control group received a video clip for self-administration of CRM according to the type of BPPV that had been diagnosed on enrollment. The primary outcome was self-reported resolution of positional vertigo post-CRM. Secondary outcomes included difficulties and requirement for assistance when using the program and any falls or other adverse events related to CRM. The primary outcome was analyzed using both intention-to-treat and per-protocol methods. Of 585 patients enrolled, 292 were randomized to the treatment group (mean [SD] age, 60.3 [12.8] years, 37 [64%] women) and 293 were randomized to the control group (mean [SD] age, 61.1 [13.2] years; 50 [71%] women). Overall, 128 (21.9%) had recurrence (58 in the treatment group and 70 in the control group), and 109 (85.2%) successfully used the web-based system. In the intention-to-treat analysis, 42 of 58 individuals (72.4%) in the treatment group and 30 of 70 individuals (42.9%) in the control group reported vertigo resolution (χ2 test: 95% CI, 0.13-0.46; P < .001). This trial proved the efficacy of a web-based system for the diagnosis and treatment of recurrent BPPV. Use of this system may play an important role in telemedicine for vestibular disorders. Clinical Research Information Service Identifier: KCT0002364.

Effects of three-dimensional image based insole for healthy volunteers: a pilot clinical trial.

Clinical Research Information Service Identifier: KCT0008100.

Efficacy of active noise-canceling headphones in patients undergoing ultrasonic scaling.

Dental fear hinders patients from receiving appropriate dental treatment. In particular, the noise generated by high-speed air turbines and ultrasonic scalers can adversely affect patients. Many efforts have been made to reduce the discomfort caused by noise, but no methods are definitively recommended. The purpose of this study was to determine the efficacy of active noise-canceling (ANC) headphones in reducing the pain and discomfort associated with dental scaling. Fifty-five patients requiring scaling and root planing, aged ≥19 years and showing no auditory problems, were included. Scaling was performed for the bilateral maxillary molars and premolars while patients wore headphones, with ANC turned either on or off. The degree of noise and pain reduction in the on and off conditions were surveyed using a visual analog scale (VAS). The Wilcoxon signed-rank test was performed to compare noise- and pain-related discomfort with ANC turned on and off. The sample included 28 men and 27 women with a mean age of 45.45±13.12 years. The average noise-related discomfort score was 3.84±2.12 and 2.95±1.99 when noise-canceling was turned off and on, respectively, with a statistically significant difference (P<0.05). Similarly, the average pain-related discomfort score was 3.78±2.00 and 3.09±1.96 when noise-canceling was turned off and on, respectively, which was a statistically significant difference (P<0.05). The use of ANC headphones seems to reduce the discomfort caused by noise and pain in patients undergoing scaling. Clinical Research Information Service Identifier: KCT0007093.

Evaluation of the clinical and radiographic effectiveness of treating peri-implant bone defects with a new biphasic calcium phosphate bone graft: a prospective, multicenter randomized controlled trial.

Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 40% β-TCP and 60% HA compared to demineralized bovine bone mineral (DBBM). This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ² test. Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM. Clinical Research Information Service Identifier: KCT0006428.

Effect of a Motivational Interviewing-Based Brief Intervention on Alcohol Use Behavior in Korean Internal Medicine Settings.

A motivational interviewing (MI)-based brief intervention was performed with high-risk drinking outpatients screened at internal medicine settings in Korea after the doctor advised them to reduce alcohol consumption. Participants were assigned to a MI group or a control group where they received a brochure with information on the harm of high-risk drinking and tips on managing drinking habits. Four-week follow-up results showed that Alcohol Use Disorders Identification Test-Concise (AUDIT-C) scores decreased in the MI group and the control group compared to baseline scores. The difference between groups was not significant; however, group by time interaction was significant between the two groups: the slope of decreasing AUDIT-C scores over time was greater in the intervention group than in the control group (P = 0.042). The findings suggest that short comments received from doctors might be a key component in performing brief interventions for high-risk drinking management in Korean clinical settings. Trial Registration: Clinical Research Information Service Identifier: KCT0002719.

Factors Associated With the Development and Severity of Polycystic Liver in Patients With Autosomal Dominant Polycystic Kidney Disease.

Factors related to the development and severity of polycystic liver disease (PLD) have not been well established. We aimed to evaluate the genetic and epidemiologic risk factors of PLD in patients with autosomal dominant polycystic kidney disease (ADPKD). Adult patients with inherited cystic kidney disease were enrolled from May 2019 to May 2021. Demographic, clinical, and laboratory data were collected at the initial study visit. The severity of PLD was graded based on the height-adjusted total liver volume: < 1,000 mL/m (Gr1), 1,000-1,800 mL/m (Gr2), and > 1,800 mL/m (Gr3). Targeted exome sequencing was done by a gene panel including 89 ciliopathy-related genes. We searched out the relative factors to the presence and the severity of PLD using logistic regression analysis. Of 602 patients with typical ADPKD, 461 (76.6%) patients had PLD. The patients with PLD showed female predominance and a higher frequency of other ADPKD-related complications. The genetic variants with truncating mutation of PKD1 (PKD1-protein-truncating [PT]) or PKD2 commonly affected the development and severity of PLD. An older age, female sex, and higher kidney volume with Mayo classification 1C-1E was significantly associated with the development of PLD, but not with the severity of PLD. On the other hand, higher body mass index, lower hemoglobin, and higher alkaline phosphatase (ALP) were the significant risk factors of severe PLD (≥ Gr2). Hepatic involvement in ADPKD could be related to kidney manifestations and genetic variants including PKD1-PT or PKD2. Monitoring hemoglobin and ALP and evaluating the genetic variants might help predict severe PLD. Clinical Research Information Service Identifier: KCT0005580.

The effects of dietary self-monitoring intervention on anthropometric and metabolic changes via a mobile application or paper-based diary: a randomized trial.

Weight loss via a mobile application (App) or a paper-based diary (Paper) may confer favorable metabolic and anthropometric changes. A randomized parallel trial was conducted among 57 adults whose body mass indices (BMIs) were 25 kg/m2 or greater. Participants randomly assigned to either the App group (n = 30) or the Paper group (n = 27) were advised to record their foods and supplements through App or Paper during the 12-week intervention period. Relative changes of anthropometries and biomarker levels were compared between the 2 intervention groups. Untargeted metabolic profiling was identified to discriminate metabolic profiles. Out of the 57 participants, 54 participants completed the trial. Changes in body weight and BMI were not significantly different between the 2 groups (P = 0.11). However, body fat and low-density lipoprotein (LDL)-cholesterol levels increased in the App group but decreased in the Paper group, and the difference was statistically significant (P = 0.03 for body fat and 0.02 for LDL-cholesterol). In the metabolomics analysis, decreases in methylglyoxal and (S)-malate in pyruvate metabolism and phosphatidylcholine (lecithin) in linoleic acid metabolism from pre- to post-intervention were observed in the Paper group. In the 12-week randomized parallel trial of weight loss through a App or a Paper, we found no significant difference in change in BMI or weight between the App and Paper groups, but improvement in body fatness and LDL-cholesterol levels only in the Paper group under the circumstances with minimal contact by dietitians or health care providers. Clinical Research Information Service Identifier: KCT0004226.

Reference Respiratory Muscle Strength Values and a Prediction Equation Using Physical Functions for Pulmonary Rehabilitation in Korea.

In Korea, tests for evaluating respiratory muscle strength are based on other countries' clinical experience or standards, which can lead to subjective evaluations. When evaluating respiratory function based on the standards of other countries, several variables, such as the race and cultures of different countries, make it difficult to apply these standards. The purpose of this study was to propose objective respiratory muscle strength standards and predicted values for healthy Korean adults based on age, height, weight, and muscle strength, by measuring maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), and peak cough flow (PCF). This cross-sectional study analyzed MIP, MEP, and PCF in 360 people, each group comprising 30 adult men and women aged 20-70, diagnosed as healthy after undergoing medical check-ups at a general hospital. Hand grip strength (HGS) and the five times sit-to-stand test (FTSST) results were also recorded. Correlations among respiratory muscle strength, participant demographics, and overall muscle strength were evaluated using Pearson's correlation analysis. The predicted values of respiratory muscle strength were calculated using multiple regression analysis. Respiratory muscle strength differed from the values reported in studies from other countries. In the entire samples, both MIP and MEP had the highest correlations with peak HGS (r = 0.643, r = 0.693; P < 0.05), while PCF had the highest correlation with forced expiratory volume in 1 s (r = 0.753; P < 0.05). Age, body mass index, peak HGS, and FTSST results were independent variables affecting respiratory muscle strength. A predictive equation for respiratory muscle strength was developed using the multiple regression equation developed in this study. Respiratory muscle strength index may differ by country. For more accurate diagnoses, standard values for each country are required. This study presents reference values for Korea, and a formula for estimation is proposed when no respiratory muscle strength measurement equipment is available. Clinical Research Information Service Identifier: KCT0006778.

Porcine-derived soft block bone substitutes for the treatment of severe class II furcation-involved mandibular molars: a prospective controlled follow-up study.

No evidence exists regarding the advantages of periodontal regeneration treatment for furcation defects using soft block bone substitutes. Therefore, this randomized controlled trial aimed to assess the clinical and radiographic outcomes of regenerative therapy using porcine-derived soft block bone substitutes (DPBM-C, test group) compared with porcine-derived particulate bone substitutes (DPBM, control group) for the treatment of severe class II furcation defects in the mandibular molar regions. Thirty-five enrolled patients (test group, n=17; control group, n=18) were available for a 12-month follow-up assessment. Clinical (probing pocket depth [PPD] and clinical attachment level [CAL]) and radiographic (vertical furcation defect; VFD) parameters were evaluated at baseline and 6 and 12 months after regenerative treatment. Early postoperative discomfort (severity and duration of pain and swelling) and wound healing outcomes (dehiscence, suppuration, abscess formation, and swelling) were also assessed 2 weeks after surgery. For both treatment modalities, significant improvements in PPD, CAL, and VFD were found in the test group (PPD reduction of 4.1±3.0 mm, CAL gain of 4.4±2.9 mm, and VFD reduction of 4.1±2.5 mm) and control group (PPD reduction of 2.7±2.0 mm, CAL gain of 2.0±2.8 mm, and VFD reduction of 2.4±2.5 mm) 12 months after the regenerative treatment of furcation defects (P<0.05). However, no statistically significant differences were found in any of the measured clinical and radiographic parameters, and no significant differences were observed in any early postoperative discomfort and wound healing outcomes between the 2 groups. Similar to DPBM, DPBM-C showed favorable clinical and radiographic outcomes for periodontal regeneration of severe class II furcation defects in a 12-month follow-up period. Clinical Research Information Service Identifier: KCT0007305.

Efficacy and Safety of ClearCut™ Knife H-type in Endoscopic Submucosal Dissection for Gastric Neoplasms: A Multicenter, Randomized Trial.

Endoscopic submucosal dissection (ESD) is an effective treatment for early gastrointestinal neoplasms. However, this is a time-consuming procedure requiring various devices. This study aimed to evaluate the efficacy and safety of the ClearCut™ Knife H-type, which is an integrated needle-tipped and insulated-tipped (IT) knife. Between July 2020 and September 2021, 99 patients with gastric epithelial neoplasms scheduled for ESD at three tertiary care hospitals were randomly assigned to H-knife (ClearCut™ Knife H-type) or IT-knife (conventional IT knife) groups. Procedure times, therapeutic outcomes, and adverse events were analyzed. A total of 98 patients (50 in the H-knife group and 48 in the IT-knife group) were analyzed. The median total procedure time was 11.9 minutes (range, 4.4-47.2 minutes) in the H-knife group and 12.7 minutes (range, 5.2-137.7 minutes) in the IT-knife group (P=0.209). Unlike the IT-knife group, which required additional devices in all cases, no additional devices were used in the H-knife group (P<0.001). En-bloc resection was performed for all lesions in both groups. The incidence of adverse events was not significantly different between groups (4.0% in the H-knife group vs. 8.3% in the IT-knife group; P=0.431). The newly developed hybrid device, the ClearCut™ Knife H-type, had comparable efficacy to the conventional IT knife for gastric ESD. Clinical Research Information Service Identifier: KCT0005164.

QTc interval prolongation due to spinal anesthesia in patients with and without diabetes: an observational study

BackgroundSpinal anesthesia and autonomic neuropathy (caused by diabetes) prolong the QTc interval. Changes in the duration of the QTc interval following subarachnoid blockade in patients with diabetes have not been evaluated. We hypothesized that after subarachnoid blockade, QTc interval prolongation would be greater in patients with diabetes than in those without. Accordingly, we compared the QTc interval, T wave peak-to-end interval (Tp-e interval), blood pressure, heart rate, and heart rate variability before and after spinal anesthesia in patients with and without diabetes.MethodsThis prospective observational study (Clinical Research Information Service identifier: KCT0004897) was conducted in a tertiary university hospital and included 24 patients with diabetes mellitus (DM group) and 24 patients without it (control group) who were scheduled for spinal anesthesia. The QTc interval, Tp-e interval, heart rate variability, blood pressure, and heart rate were measured before (T1) and 1 (T2), 5 (T3), and 10 min (T4) following subarachnoid blockade.ResultsTen minutes following subarachnoid blockade, the QTc intervals of patients in the DM group were significantly longer than the baseline values, whereas the change in the QTc interval in the control group was not significant (p < 0.0001 vs. p = 0.06).ConclusionSpinal anesthesia caused a more significant prolongation of the QTc interval in patients with diabetes than in those without.

Comparison of the Analgesic Efficacy of Opioid-Sparing Multimodal Analgesia and Morphine-Based Patient-Controlled Analgesia in Minimally Invasive Surgery for Colorectal Cancer.

A multimodal analgesia (MMA) protocol has shown the effect of postoperative pain control and reduced the postoperative opioid consumption. However, it was questionable whether MMA could replace opioid-based patient-controlled analgesia (PCA) for postoperative pain control. Therefore, this study aimed to investigate whether an MMA protocol is non-inferior to opioid-based PCA for pain management after a minimally invasive colorectal cancer surgery. A randomized, open-label, non-inferiority clinical trial was conducted on patients undergoing laparoscopic or robotic resection of colorectal cancer. The patients were randomly assigned to either the PCA or MMA group. The MMA protocol included pregabalin, tramadol, wound infiltration, and transversus abdominis plane block. The primary outcome was the numeric rating scale (NRS) score for pain at rest 24h postoperatively. Ninety-seven patients were included in the intention-to-treat analysis. The mean difference in NRS score at rest at 24h was 0.25 (95% confidence interval, - 0.61 to 1.11). This result demonstrated the non-inferiority of MMA to PCA in our non-inferiority margin (- 1). Compared with the PCA group, the median remifentanil dose (996 vs. 654μg; p < 0.001) and time in the post-anesthesia care unit (35 vs. 25min; p < 0.001) were significantly less in the MMA group. Our MMA protocol successfully controlled postoperative pain and was non-inferior to morphine-based PCA based on patient-reported pain intensity, with no significant increase in adverse events. These results will help construct a strategy to reduce conventional opioid prescriptions for pain management after a minimally invasive colorectal cancer surgery. Trial Registration Number Trial Registration Clinical Research Information Service Identifier: KCT0002593.

Effects of Mobile Healthcare Applications on the Lifestyle of Patients With Breast Cancer: A Protocol for a Randomized Clinical Trial.

Physical activity (PA) in patients with breast cancer is associated with improved quality of life (QoL); however, many breast cancer survivors do not meet the recommended PA level. This study aims to evaluate the effect of digital health interventions using mobile apps to promote PA and QoL in patients with postoperative breast cancer. This study will also identify effective digital intervention methods and perform an economic analysis. The main hypothesis is that the use of mobile healthcare apps will improve health-related quality of life (HRQOL), promote PA, and reduce healthcare costs. The Promotion of a better lifestyle (PA) with Precise and Practicable digital healthcare in postoperative CANCER patients through a Multi-Disciplinary Network (P4CancerMDnet) study is examined by a prospective 4-group randomized controlled trial with a concurrent cost-utility evaluation. Patients are randomly assigned to 3 different mobile app intervention groups or control groups in a 1:1:1:1 ratio. The intervention group is encouraged to use the assigned mobile app. The targeted outcomes are HRQOL, metabolic health markers, and quality-adjusted life-years. The outcomes will be measured at the 6- and 12-month follow-ups. This study will contribute towards a better lifestyle and HRQOL through digital healthcare for postoperative breast cancer patients. These findings are expected to provide evidence of the effectiveness of mobile apps for breast cancer survivors. Clinical Research Information Service Identifier: KCT0005447.

Evaluation of food effects on the pharmacokinetics of Pelargonium sidoides and Coptis with each bioactive compound berberine and epicatechin after a single oral dose of an expectorant and antitussive agent UI026 in healthy subjects.

UI026 is an expectorant and antitussive agent which is a new combination of Pelargonium sidoides extract and Coptis extract. The bioactive compounds of Pelargonium sidoides and Coptis extracts were identified as epicatechin and berberine, respectively. This study evaluated the effect of food on the pharmacokinetics (PKs) and safety of UI026. A randomized, open-label, single-dose, 2-treatment, parallel study in 12 healthy male subjects was performed. Subjects received a single oral dose of UI026 (27 mL of syrup) under a fed or fasted condition according to their randomly assigned treatment. Blood samples for the PK analysis were obtained up to 24 hours post-dose for berberine and 12 hours post-dose for epicatechin. The PK parameters were calculated by non-compartmental analysis. In the fed condition, the mean maximum plasma concentration (Cmax) and mean area under the plasma concentration-time curve from time zero to the last observed time point (AUClast) for berberine were approximately 33% and 67% lower, respectively, compared with the fasted condition, both showing statistically significant difference. For epicatechin, the mean Cmax and mean AUClast were about 29% and 45% lower, respectively, compared to the fasting condition, neither of which showed a statistically significant difference. There were no drug-related adverse events. This finding suggests that food affects the systemic exposure and bioavailability of berberine and epicatechin.Trial RegistrationClinical Research Information Service Identifier: KCT0003451

Safety of Gastrointestinal Endoscopy in Korea: A Nationwide Survey and Population-Based Study.

BackgroundAttention should be paid to endoscopy-related complications and safety-related accidents that may occur in the endoscopy unit. This study investigated the current status of complications associated with diagnostic and therapeutic endoscopy in Korea.MethodsA questionnaire survey on endoscopy-related complications was conducted in a total of 50 tertiary or general hospitals in Korea. The results were compared to the population-level claims data from the Health Insurance Review & Assessment Service (HIRA), which analyzed endoscopy procedures conducted in 2017 in Korea.ResultsThe incidences of bleeding associated with diagnostic and therapeutic esophagogastroduodenoscopy (EGD) and with diagnostic and therapeutic colonoscopy were 0.224% and 3.155% and 0.198% and 0.356%, respectively, in the 2017 HIRA claims data, compared to 0.012% and 1.857%, and 0.024% and 0.717%, in the 50 hospitals surveyed. The incidences of perforation associated with diagnostic and therapeutic EGD and with diagnostic and therapeutic colonoscopy were 0.023% and 0.613%, and 0.007% and 0.013%, respectively, in the 2017 HIRA claims data compared to 0.001% and 0.325%, and 0.017% and 0.206%, in the 50 hospitals surveyed. In the HIRA claims data, the incidence of bleeding/perforation after diagnostic colonoscopy in clinics, community hospitals, general hospitals, and tertiary hospitals was 0.129%/0.000%, 0.088%/0.004%, 0.262%/0.009%, and 0.479%/0.030% respectively, and the corresponding incidence of bleeding/perforation after therapeutic colonoscopy was 0.258%/0.004%, 0.401%/0.007%, 0.408%/0.024%, and 0.731%/0.055%.ConclusionThe incidences of complications associated with diagnostic and therapeutic EGD or colonoscopy tended to increase with the hospital volume in Korea.Trial RegistrationClinical Research Information Service Identifier: KCT0001728

Implementation and Outcomes of a Difficult Airway Code Team Composed of Anesthesiologists in a Korean Tertiary Hospital: A Retrospective Analysis of a Prospective Registry.

BackgroundIn 2017, we established an airway call (AC) team composed of anesthesiologists to improve emergency airway management outside the operating room. In this retrospective analysis of prospectively collected data from the airway registry, we describe the characteristics of patients attended to and practices by the AC team during the first 4 years of implementation.MethodsAll AC team activations in which an airway intervention was performed by the AC team between June 2017 and May 2021 were analyzed.ResultsIn all, 359 events were analyzed. Activation was more common outside of working hours (62.1%) and from the intensive care unit (85.0%); 36.2% of AC activations were due to known or anticipated difficult airway, most commonly because of acquired airway anomalies (n = 49), followed by airway edema or bleeding (n = 32) and very young age (≤ 1 years; n = 30). In 71.3% of the cases, successful intubation was performed by the AC team at the first attempt. However, three or more attempts were performed in 33 cases. The most common device used for successful intubation was the videolaryngoscope (59.7%). Tracheal intubation by the AC team failed in nine patients, who then required surgical airway insertion by otolaryngologists. However, there were no airway-related deaths.ConclusionsWhen coupled with appropriate assistance from an otolaryngologist AC system, an AC team composed of anesthesiologists could be an efficient way to provide safe airway management outside the operating room.Trial RegistrationClinical Research Information Service Identifier: KCT0006643