• Journal of Gastric Cancer
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• v.19 no.2
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• pp.157-164
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• 2019

Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

• Safety and Health at Work
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• v.13 no.2
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• pp.240-247
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• 2022

Background: Although insomnia and constipation are highly prevalent worldwide, studies examining a possible association between them are lacking. We examined the relationship between insomnia and constipation in shift workers who have a high prevalence of insomnia and other diseases. Methods: This study had a multicenter cross-sectional design and conducted using health examination data including self-reported questionnaires. In total, 12,879 and 4,650 shift workers were enrolled in Severance Hospital and Wonju Severance Hospital, respectively, during 2015-2017. Multivariate logistic regression models and subgroup analysis were performed in each center with the same protocol, using a common data model. Results: The mean age of the total population was 44.35 (standard deviation = 8.75); the proportion of males was 56.9%. Female sex, being underweight and non-smoker were strongly associated with an increased risk of constipation symptom (p < 0.001). Pooled odds ratios (ORs) were calculated using ORs of both centers with weights; there was a significant dose-response relationship (sub-threshold 1.76 [95% confidence interval [CI] 1.62-1.91]; moderate 2.28 [95% CI 2.01-2.60]; severe 4.15 [95% CI 3.18-5.41] in the final model, p for trend < 0.001). Subgroup analysis performed by stratifying sex and pooled ORs showed a similar trend to that of the entire group. Conclusion: We observed a strong correlation between insomnia and constipation in this population. Our findings may help in formulating guidelines and policies to improve quality of life in shift workers through the management of sleep quality and proper bowel function. This study is the first to report this relationship among people working in shifts.

• The Journal of Korean Obstetrics and Gynecology
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• v.23 no.1
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• pp.42-52
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• 2010

Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

• Journal of Korean Neurosurgical Society
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• v.47 no.2
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• pp.112-118
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• 2010

Objective : There have been no clinical studies regarding the epidemiology and treatment outcome for unruptured intracranial aneurysm (UIA) in South Korea yet. Thus, The Korean Society of Cerebrovascular Surgery (KSCVS) decided to evaluate the clinical and epidemiological characteristics, and outcome of the treatment of UIA in 2006, using the nationwide multicenter survey in South Korea. Methods : A total of 1,696 cases were enrolled retrospectively over one year at 48 hospitals. The following data were obtained from all patients : age, sex, presence of symptoms, location and size of the aneurysm, treatment modality, presence of risk factors for stroke, and the postoperative 3D-day morbidity and mortality. Results : The demographic data showed female predominance and peak age of seventh and sixth decades. Supraclinoid internal carotid artery was the most common site of aneurysms with a mean size of 5.6 mm. Eight-hundred-forty-six patients (49.9%) were treated with clipping, 824 (48.6%) with coiling, and 26 with combined method. The choice of the treatment modalities was related to hospital (p=0.000), age (p=0.000), presence of symptom (p=0.003), and location of aneurysm (p=0.000). The overall 30-day morbidity and mortality were 7.4% and 0.3%, respectively. The 30-day mortality was 0.4% for clipping and 0.2% for coiling, and morbidity was 8.4% for clipping and 6.3% for coiling. Age (p=0.010), presence of symptoms (p=0.034), size (p=0.000) of aneurysm, and diabetes mellitus (p=0.000) were significant prognostic factors, while treatment modality was not. Conclusion : This first nation-wide multicenter survey on UIAs demonstrates the epidemiological and clinical characteristics, outcome and the prognostic factors of the treatment of UIAs in South Korea. The 30-day postoperative outcome for UIAs seems to be reasonable morbidity and mortality in South Korea.

• 대한임상약리학회:학술대회논문집
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• 1996.12a
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• pp.28-28
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• 1996

• Journal of Sasang Constitutional Medicine
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• v.24 no.2
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• pp.47-53
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• 2012

1. Objectives : The aim of the present study was to describe the Korea Constitutional Multicenter Bank (KCMB), which was various clinical data bank for scientific advancement of constitutional diagnosis and treatment. 2. Methods and Results : The KCMB is based on the 28 multi-institute cooperative clinical research networks including domestic and international institute. Since the KCMB was founded in 2006, data have been accumulated from 10,412 subjects. The KCMB consists of three parts: The clinical constitutional data, the measurement data, and the biological data. The method of data entry is via web based electronic Case Report From (eCRF). The eCRF has been developed and programed to ensure the efficient entry of data. We also developed coding manual, ongoing quality control assessment to obtain high-quality data. 3. Conclusions : The KCMB with various data contribute to providing the scientification of Sasang Constitutional Medicine.

• Journal of Hospice and Palliative Care
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• v.24 no.1
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• pp.66-68
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• 2021

The World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak to be a pandemic on March 12, 2020. In Korea, there have been 24,027 confirmed cases of COVID-19 and 420 deaths as of October 3, 2020. The clinical spectrum of COVID-19 ranges from asymptomatic infection to death. Cancer care in this pandemic has radically changed. The literature was reviewed. The COVID-19 pandemic has made it urgently necessary to profoundly re-organize cancer patients' care without compromising cancer outcomes. Several important questions in regard to COVID-19 infection in cancer patients have emerged. Are patients with cancer at a higher risk of COVID-19 infection? Are they at an increased risk of mortality and severe illness when infected with COVID-19? Does anticancer treatment affect the course of COVID-19? Based on the existing research, cancer patients with immunosuppression are vulnerable to COVID-19 infection, and cancer patients are more likely to experience severe COVID-19. However, chemotherapy and major surgery do not seem to be predictors of hospitalization or severe disease. Korean background data on patients with cancer and COVID-19 are lacking. Prospective multicenter studies on the outcomes of patients with cancer and COVID-19 should be conducted.

• Journal of the Korea Convergence Society
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• v.12 no.8
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• pp.327-333
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• 2021

Zoster-associated pain (ZAP) in patients with herpes zoster (HZ) may persist for a long time, occurring even years after the rash has healed. In this case, the patient is diagnosed as having postherpetic neuralgia (PHN). Prodromal symptoms can present with constant or intermittent pain, and are often accompanied by other symptoms, resulting in misdiagnosis and/or inappropriate treatment. The aim of this study is to investigate the characteristics of the prodromal symptoms of ZAP through a multicenter study in Korea.

• Journal of Gastric Cancer
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• v.18 no.1
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• pp.30-36
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• 2018

Purpose: We investigated complications after laparoscopic sentinel basin dissection (SBD) for patients with gastric cancer who were enrolled in a quality control study, prior to the phase III trial of sentinel lymph node navigation surgery (SNNS). Materials and Methods: We analyzed prospective data from a Korean multicenter prerequisite quality control trial of laparoscopic SBD for gastric cancer and assessed procedure-related and surgical complications. All complications were classified according to the Clavien-Dindo Classification (CDC) system and were compared with the results of the previously published SNNS trial. Results: Among the 108 eligible patients who were enrolled in the quality control trial, 8 (7.4%) experienced complications during the early postoperative period. One patient with gastric resection-related duodenal stump leakage recovered after percutaneous drainage (grade IIIa in CDC). The other postoperative complications were mild and patients recovered with supportive care. No complications were directly related to the laparoscopic SBD procedure or tracer usage, and there were no mortalities. The laparoscopic SBD complication rates and patterns that were observed in this study were comparable to those of a previously reported trial. Conclusions: The results of our prospective, multicenter quality control trial demonstrate that laparoscopic SBD is a safe procedure during SNNS for gastric cancer.

• The Journal of Internal Korean Medicine
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• v.42 no.4
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• pp.510-531
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• 2021

Objectives: The purpose of this study was to review the status of numeric rating scale (NRS) usage and suggest the potential for use in multicenter retrospective studies of various diseases. Methods: Articles published from 2011 to 2021 that used the keywords "NRS", "Multi-center", and "RCT" were identified in foreign databases, including EMBASE, PubMed, CENTRAL. The articles were analyzed according to their use of "NRS" by symptoms and by disease group using the major classifications of the Korean Standard Classification of Diseases (KCD-7). Results: Classification by symptom in a total of 288 articles illustrates that the NRS was not only commonly used in pain evaluation but also for non-pain symptoms. In usage with non-pain symptoms, chief complaint of patients was the most common at 79%, and other factors included treatment satisfaction, evaluation of daily life, and sleep quality. In disease classification according to the KCD-7, the NRS was commonly used in connection with musculoskeletal and connective tissue diseases but was also utilized in various other disease groups. Conclusions: This study confirms usage of the NRS in multi-center RCTs, as the NRS was widely used in all types of diseases and symptoms. Considering the result and the advantages of the NRS, it is recommended for use as a daily evaluation tool for the collection of common data in multicenter retrospective studies.