• Journal of Korean Neurosurgical Society
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• 제39권1호
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• pp.11-15
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• 2006

Objective : A prospective, randomized, controlled clinical study is performed to verify the effectiveness of epidural dexamethasone-soaked gelatin sponges to reduce postoperative pain following lumbar microdiscectomy. Methods : Twenty-three patients (10 men and 13 women) undergoing lumbar microdiscectomy were included. Five pieces of gelatin sponge measuring $1{\times}1cm$ [Gelfoam; Pharmacia & Upjohn. Kalamazoo, MI, USA], soaked with either 5mg dexamethasone or an equal amount [2mL] of saline, were left on the decompressed nerve root after unilateral hemilami-nectomy, flavectomy and discectomy. Results : Subjective visual analog scale[VAS] scores of leg pain in the dexamethasone group on the first, third and first postoperative days [2.5, 2.5, 1.7, respectively] were significantly lower than in the control group [5.0, 4.8, 3.6][P<0.05]. No side effects related to the dexamethasone-soaked gelatin sponges were observed. Conclusion : The intraoperative application of dexamethasone-soaked gelatin sponges during lumber microdiscetomy can provide effective-postoperative analgesia without complications.

• Journal of Gastric Cancer
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• 제24권3호
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• pp.257-266
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• 2024

Purpose: We conducted a randomized prospective trial (KLASS-07 trial) to compare laparoscopy-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer. In this interim report, we describe short-term results in terms of morbidity and mortality. Methods and Methods: The sample size was 442 participants. At the time of the interim analysis, 314 patients were enrolled and randomized. After excluding patients who did not undergo planned surgeries, we performed a modified per-protocol analysis of 151 and 145 patients in the LADG and TLDG groups, respectively. Results: The baseline characteristics, including comorbidity status, did not differ between the LADG and TLDG groups. Blood loss was somewhat higher in the LADG group, but statistical significance was not attained (76.76±72.63 vs. 62.91±65.68 mL; P=0.087). Neither the required transfusion level nor the operation or reconstruction time differed between the 2 groups. The mini-laparotomy incision in the LADG group was significantly longer than the extended umbilical incision required for specimen removal in the TLDG group (4.79±0.82 vs. 3.89±0.83 cm; P<0.001). There were no between-group differences in the time to solid food intake, hospital stay, pain score, or complications within 30 days postoperatively. No mortality was observed in either group. Conclusions: Short-term morbidity and mortality rates did not differ between the LADG and TLDG groups. The KLASS-07 trial is currently underway.

• 대한한의학회지
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• 제31권5호
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• pp.1-11
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• 2010

Objectives: This study aimed to evaluate any clinical studies regarding rhinitis published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to rhinitis was initially obtained from journals of the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 36 initially obtained articles, 17 were finally analyzed. 2 articles were randomized controlled studies, 6 articles were prospective whereas 9 were retrospective. In the prospective articles, there were no randomized controlled trials and the other non-randomized studies had no control group with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described rhinitis diagnosis objectively and outcome measures were either non-relevant to rhinitis or non-validated. Conclusions: Further well-designed randomized controlled studies for rhinitis are mandatory and more rigorous non-randomized controlled studies should be conducted.

• The Journal of Advanced Prosthodontics
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• 제5권2호
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• pp.204-208
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• 2013

PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.

• Archives of Plastic Surgery
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• 제32권1호
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• pp.19-23
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• 2005

Tissue adhesives have gained popularity for quicker and painless closure of lacerations. The use of tissue glue is currently popular for the closure of superficial lacerations, especially in children. Histoacryl $Blue^{(R)}$(2-N-butylcyanoacrylate) is a topical wound closure that precludes the need for foreign bodies to close wounds. The purpose of this study was to compare the applications of Histoacryl $Blue^{(R)}$(HAB) and conventional suture, regarding cosmetic outcome. To compare the short term and long term results of various repair methods, we designed the prospective, randomized, blind study. Patients with laceration undergoing repair were randomly allocated to conventional suture, subcutaneous suture plus HAB, and HAB only groups. The exclusion criterions were large wound that require large tension for repair or avulsion wound. An independent, blinded observer assessed cosmetic result at 7-10 days after repair and 3-9 months postoperatively. Physician's satisfaction with wound appearance was recorded on 100 mm Visual Analogue Scale(VAS)(0=worst, 100=best). The difference in VAS score between conventional suture method and subcutaneous suture plus HAB methods were not significant. Tissue glue being easy to use with no complications and still resulting in equivalent cosmetic outcomes has several benefits. Especially in the case of children, the wound closure with Histoacryl $Blue^{(R)}$ could be a good alternative for repair of laceration in emergency room.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 2005년도 제57차 추계 학술대회 연제집
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• pp.496-496
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• 2005

• Restorative Dentistry and Endodontics
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• 제42권2호
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• pp.140-145
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• 2017

Objectives: The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo) or single-file reciprocating (Reciproc) systems were used. Materials and Methods: Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS), ranging from 'least possible discomfort' (1) to 'greatest possible discomfort' (10). The Wilcoxon signed-rank test was used to determine significant differences at p < 0.05. Results: Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660). Conclusions: Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

• Korean Journal of Acupuncture
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• 제35권2호
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• pp.70-81
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• 2018

Objectives : To investigate the association of trial registration status with presence of reporting bias including publication bias and outcome reporting bias in recently published randomized controlled trials (RCTs) of acupuncture. Methods : A PubMed search for RCTs of acupuncture published from March 2016 to February 2017 was conducted. Primary outcomes were identified and the direction of the results was judged as positive (i.e., statistically significant) or negative. The trial registration was identified by manually screening the trial registration number in the main text of the published article and classified into 1) prospective registration; 2) retrospective registration based on the registration date or; 3) no registration. Results : Of the 125 included RCTs, only 40 studies (32.0%) prospectively registered the study protocols. Among 65 RCTs that adequately reported the primary outcome, unregistered trials were more likely to report positive results than the registered ones (p=0.013). Of the 40 prospectively registered studies, 19 trials (47.5%) had the discrepancies between the registered and published primary outcomes and furthermore, 40% of them reported the positive findings. Conclusions : Unregistered trials were more likely to report positive results and the discrepancies between the registered and published primary outcomes were detected in about a half of the prospectively registered studies, 42.1% of which tended to report positive findings. Journal editors and researchers in this field should be alerted to various reporting biases.

• Journal of Chest Surgery
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• 제52권2호
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• pp.85-90
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• 2019

Background: Variation exists in the initial treatment for the first episode of primary spontaneous pneumothorax (PSP), and no definitive consensus exists due to a lack of high-quality evidence. This study examined the outcomes of needle aspiration and closed thoracostomy in first episodes of PSP requiring intervention. Methods: This study was a randomized, prospective, single-center trial conducted between December 2015 and August 2016. Patients of all ages with a documented first episode of PSP who were unilaterally affected, hemodynamically stable, and had a pneumothorax measuring over 25% in size were included. Patients with underlying lung disease, severe comorbidities, bilateral pneumothorax, tension pneumothorax, recurrent pneumothorax, traumatic pneumothorax, and pregnancy were excluded. Patients were randomly assigned to the needle aspiration or closed thoracostomy group using a random number table. Results: Forty patients with a first episode of PSP were recruited, and 21 and 19 patients were included in the needle aspiration group and the closed thoracostomy group, respectively. The hospital stay of each group was $2.1{\pm}1.8days$ and $5.4{\pm}3.6days$, respectively (p<0.01). However, no significant differences were found in the success rate of initial treatment or the 1-month and 1-year recurrence rates. Conclusion: Needle aspiration is a favorable initial treatment in patients experiencing a first episode of PSP.

• Korean Journal of Radiology
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• 제21권11호
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• pp.1239-1247
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• 2020

Objective: To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods: In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results: Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion: Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.