• Title/Summary/Keyword: Multicenter study

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Efficacy and safety of equine cartilage for rhinoplasty: a multicenter double-blind non-inferiority randomized confirmatory clinical trial

  • Chang, Yongjoon;Yun, Hyunjong;Choi, Jong Woo;Suh, Joong Min;Jeong, Woo Shik;Park, Hojin;Kang, Min Kyu;Shin, Yongho;Kim, Kuylhee;Chung, Chul Hoon
    • Archives of Craniofacial Surgery
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    • v.23 no.4
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    • pp.152-162
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    • 2022
  • Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

An Early Experience of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in the Republic of Korea: A Retrospective Multicenter Study

  • Park, Joonhyeon;Jang, Sung Woo;Yu, Byungchul;Lee, Gil Jae;Chang, Sung Wook;Kim, Dong Hun;Chang, Ye Rim;Jung, Pil Young
    • Journal of Trauma and Injury
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    • v.33 no.3
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    • pp.144-152
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    • 2020
  • Purpose: This retrospective multicenter study analyzed trauma patients who underwent resuscitative endovascular balloon occlusion of the aorta (REBOA) in the Republic of Korea. Methods: This study was conducted from February 2017 to May 2018 at three regional trauma centers in the Republic of Korea. The patients were divided into two groups (cardiopulmonary resuscitation [CPR] and No-CPR) for comparative analysis based on two criteria (complication and mortality) for logistic regression analysis (LRA). Results: There were significant differences between the CPR and No-CPR groups in mortality (p=0.003) and treatment administered (p=0.016). By LRA for complications, total occlusion has significantly lesser risk than intermittent or partial occlusion in both univariate (odds ratio [OR] 0.06, 95% confidence interval [CI] 0.00-0.36, p=0.01) and multivariate (OR 0.05, 95% CI 0.00-0.38, p=0.01) analyses. The Rescue had a higher risk than the Coda or Reliant in univariate analysis (OR 4.91, 95% CI 1.14-34.25, p=0.05); however, it was not statistically significant in multivariate analysis (OR 6.98, 95% CI 1.03-74.52, p=0.07). By LRA for mortality, the CPR group was the only variable that had a significantly higher risk of mortality than the No-CPR group in both univariate (OR 17.59, 95% CI 3.05-335.25, p=0.01), and multivariate (OR 24.92, 95% CI 3.77-520.51, p=0.01) analyses. Conclusions: This study was conducted in the early stages of REBOA implementation in the Republic of Korea and showed conflicting results from studies conducted by multiple institutions. Therefore, additional research with more accumulated data is needed.

Characteristics of Upper Gastrointestinal Tract Involvement in Korean Pediatric Crohn's Disease: A Multicenter Study

  • Park, Ji Hyoung;Nam, Hye Na;Lee, Ji-Hyuk;Hong, Jeana;Yi, Dae Yong;Ryoo, Eell;Jeon, In Sang;Tchah, Hann
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.20 no.4
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    • pp.227-235
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    • 2017
  • Purpose: Crohn's disease (CD) can involve any site of the gastrointestinal tract (GIT). However, the characteristics of upper GIT involvement in CD are unclear, especially in the Eastern pediatric population. This study aimed to estimate the prevalence of upper GIT involvement and identify the clinical features of Korean children with CD. Methods: This was a retrospective multicenter cohort study that included 52 pediatric patients with CD who underwent esophagogastroduodenoscopy and biopsy. The clinical symptoms and endoscopic and histologic features of the upper GIT were identified according to the presence or absence of upper gastrointestinal symptoms. Results: Among the 52 patients, upper GIT involvement was noted in 50.0% (26/52). The mean age at CD diagnosis was $14.1{\pm}2.1$ years. Gastric ulcer was the most common lesion (19.2%) found on upper GIT endoscopy, followed by duodenal ulcers (15.4%). Chronic inflammation was the most common histopathologic feature (75.0%), followed by gastric erosion (17.3%). Granuloma was found in 9.6% of patients. Helicobacter pylori infection was identified in 5.8% of patients. Endoscopic and histologic findings were not significantly different, but the mean values of erythrocyte sedimentation rate ($60.7{\pm}27.1$ vs. $43.0{\pm}27.6mm/h$, p=0.037) and C-reactive protein ($16.5{\pm}28.2$ vs. $6.62{\pm}13.4mg/dL$, p=0.014) were significantly different between patients with and without upper gastrointestinal CD symptoms. Conclusion: Upper GIT involvement was relatively common in pediatric patients with CD irrespective of upper gastrointestinal symptoms, and H. pylori infection was relatively uncommon. The results of this study should aid the establishment of regional guidelines for upper GIT examination.

Fecal Retention in Overactive Bladder (OAB) in Children: Perspective of a Pediatric Gastroenterologist

  • Jeong, Su Jin
    • Childhood Kidney Diseases
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    • v.19 no.1
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    • pp.1-7
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    • 2015
  • Coexisting voiding and bowel dysfunction in children are common in the clinic. The idea that overactive bladder (OAB) and constipation arise from one single pathophysiology has been reinforced in many studies. In Korea, a nationwide multicenter study conducted in 2009 showed that overall prevalence of OAB in children, 5-13 years of age, was 16.59% and this number has increased more recently. The initial step to manage coexisting fecal retention and OAB in children is to characterize their bowel and bladder habits and to treat constipation if present. Although diagnosing constipation in children is difficult, careful history-taking using the Bristol Stool Form Scale, and a scoring system of plain abdominal radiography, can help to estimate fecal retention more easily and promptly. Non-pharmacological approaches to manage functional constipation include increasing fluids, fiber intake, and physical activity. Several osmotic laxatives are also effective in improving OAB symptoms and fecal retention. Additionally, correction and education in relation to toilet training is the most important measure in treating OAB with fecal retention.

Factors Associated with Gastric and Duodenal Neuroendocrine Tumor Development

  • Kwangwoo Nam;Su Youn Nam
    • Journal of Digestive Cancer Research
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    • v.12 no.1
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    • pp.1-5
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    • 2024
  • The incidence and prevalence of upper gastrointestinal neuroendocrine tumors (NETs), including gastric NETs (GNETs) and duodenal NETs (DNETs), have been gradually increasing. These trends may be associated with the increased use of health checkups, which includes upper endoscopy, in conjunction with better disease recognition. However, the clinical factors associated with GNETs and DNETs remain unknown; previous studies revealed discrepancies. Recently, metabolic disorders have been indicated as potential factors that are associated with GNETs and DNETs. This review summarizes the results of previous studies and briefly introduces the results of a recent Korean multicenter study on the factors associated with GNETs and DNETs.

A MULTICENTER RETROSPECTIVE STUDY OF OUTPATIENT INTRAVENOUS SEDATION FOR DENTAL TREATMENTS (치과 치료를 위한 외래 정주진정 법에 대한 다기관 후향적 임상연구)

  • Jung, Se-Hwa;Baik, Sang-Hyun;Roh, Hyun-Ki;Kang, Na-Ra;Im, Jae-Jung;Lee, Byung-Ha;Jeon, Jae-Yoon;Hwang, Kyung-Gyun;Shim, Kwang-Sup;Park, Chang-Joo
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.31 no.5
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    • pp.394-400
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    • 2009
  • Purpose : On outpatient facilities, our sedation protocol focuses on the intermittent bolus injections of midazolam intravenously, according to patient's and operator's needs during the dental treatment. This multicenter retrospective study was aimed to prove the efficiency and safety of our sedation protocol. Patients and Methods : In three centers using the same outpatient sedation protocol for dental treatment (Division of Oral and Maxillofacial Surgery/Department of Dentistry in Hanyang University Medical Center, S-plant Dental Hospital. and Grand Oral and Maxillofacial Surgery), total 937 patients had various dental treatments under intravenous conscious sedations with independent patient monitoring from March 2006 to March 2009. By reviewing charts, we analyzed the results of sedation and dental treatment, retrospectively. Results : Our sedation protocol had no severe postoperative complications requiring admission. while showing good compatibility with almost all dental treatments, with acceptable satisfaction of both patients and operators. Conclusion : We assure that our sedation protocol can be used efficiently and safely on routine outpatient basis. We also hope that this study will provide the concrete concepts to common dental practitioners, who desire to perform sedation for dental treatment.

Prevalence and Risk Factors of Functional Dyspepsia in Health Check-up Population: A Nationwide Multicenter Prospective Study

  • Kim, Sung Eun;Kim, Nayoung;Lee, Ju Yup;Park, Kyung Sik;Shin, Jeong Eun;Nam, Kwangwoo;Kim, Hyeon Ju;Song, Hyun Joo;Joo, Young-Eun;Myung, Dae-Seong;Seo, Ji-Hyun;Jo, Hyun Jin;Kim, Seon Mie;Lim, Seon Hee;Kim, Hyun Jin;Baik, Gwang Ho;Choi, Sang Hyeon;Choi, Suck Chei
    • Journal of Neurogastroenterology and Motility
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    • v.24 no.4
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    • pp.603-613
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    • 2018
  • Background/Aims Functional dyspepsia (FD) is one of the most common gastrointestinal disorders, and FD imposes social and economic burden worldwide. The aim of this study is to identify the prevalence and risk factors of FD in health check-up population in tertiary centers in Korea. Methods A nationwide multicenter prospective study was performed at 9 tertiary healthcare centers in Korea between September 2016 and June 2017. A total of 2525 subjects were investigated based on endoscopic findings and questionnaires with the Rome III criteria, and Helicobacter pylori serology (IgG). Results A total of 1714 subjects without organic disease were enrolled. The mean (${\pm}SD$) age was 51.5 (${\pm}12.7$) years, and 917 patients (53.5%) were female. The proportion of H. pylori seropositivity was 51.0% (874/1714). The prevalence of FD was 10.3% (176/1714), and the subtypes of postprandial distress syndrome alone, epigastric pain syndrome alone, and postprandial distress syndromeepigastric pain syndrome overlap were 4.8%, 3.0%, and 2.5%, respectively. Multivariate analysis showed that female gender (OR, 1.58; 95% CI, 1.14-2.21) and education below college level (OR, 1.45; 95% CI, 1.01-2.07) were related to FD. Multivariate analysis based on age 60 showed female gender as a significant (OR, 2.90; 95% CI, 1.06-7.94) factor in the group ${\geq}60$ years. Conclusions The prevalence of FD was 10.3% in the health check-up population in Korea. Female sex and education below college level were risk factors for FD. Female sex is a risk factor for FD in old age, underscoring the need for close attention in this age group.