• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.6
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• pp.377-386
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• 2020

Background: To compare pain perception during palatal injection administration in children aged 7-9 years while using pre-cooling of the injection site versus application of topical anesthesia as a pre-injection anesthetic during the six months. Method: A prospective randomized split-mouth crossover trial was conducted among 30 children aged 7-9 years, who received topical application of either a pencil of ice (test group) or 5% lignocaine gel (control group) for 2 min before injection. The primary and secondary outcome measures were pain perception and child satisfaction, measured by the composite pain score and the faces rating scale, respectively. Unpaired t-test was performed to determine significant differences between groups. Results: The test group had significantly lower pain scores for self-report and behavioral measures (P < 0.0001). The changes in physiological parameters at the baseline (P = 0.74) during (P = 0.37) and after (P = 0.88) the injection prick were not statistically significant. Children felt better by the pre-cooling method (P < 0.0001). Conclusion: Ice application using a pencil of ice for 2 min reduced pain perception significantly compared to the use of a topical anesthetic. Moreover, ice application was preferred by children.

• Journal of Gastric Cancer
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• v.17 no.3
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• pp.255-266
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• 2017

Purpose: Although Roux-en-Y (R-Y) reconstruction after distal gastrectomy has several advantages, such as prevention of bile reflux into the remnant stomach, it is rarely used because of the technical difficulty. This prospective randomized clinical trial aimed to show the efficacy of a novel method of R-Y reconstruction involving the use of 2 circular staplers by comparing this novel method to Billroth-I (B-I) reconstruction. Materials and Methods: A total of 118 patients were randomly allocated into the R-Y (59 patients) and B-I reconstruction (59 patients) groups. R-Y anastomosis was performed using two circular staplers and no hand sewing. The primary end-point of this clinical trial was the reflux of bile into the remnant stomach evaluated using endoscopic and histological findings at 6 months after surgery. Results: No significant differences in clinicopathological findings were observed between the 2 groups. Although anastomosis time was significantly longer for the patients of the R-Y group (P<0.001), no difference was detected between the 2 groups in terms of the total surgery duration (P=0.112). Endoscopic findings showed a significant reduction of bile reflux in the remnant stomach in the R-Y group (P<0.001), and the histological findings showed that reflux gastritis was more significant in the B-I group than in the R-Y group (P=0.026). Conclusions: The results of this randomized controlled clinical trial showed that compared with B-I reconstruction, R-Y reconstruction using circular staplers is a safe and feasible procedure. This clinical trial study was registered at www.ClinicalTrials.gov (registration No. NCT01142271).

• Journal of Periodontal and Implant Science
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• v.53 no.4
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• pp.306-317
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• 2023

Purpose: 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 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: 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. Results: 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. Conclusions: 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.

• Advances in pediatric surgery
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• v.20 no.2
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• pp.48-52
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• 2014

Purpose: Currently the substantial clinical benefits of single-port laparoscopic appendectomy (SLA) over conventional three-port laparoscopic appendectomy (CLA) are equivocal. The aim of this study was to compare surgical outcomes between SLA and CLA in children with acute appendicitis. Methods: A single blind prospective randomized single center study was performed to compare the surgical outcomes of SLA and CLA. A total of 105 patients were randomized and various parameters were analyzed, 52 patients with SLA and 53 patients with CLA between July 2013 and March 2014. Patients with sonographically confirmed acute appendicitis were randomly assigned to receive either SLA or CLA. The outcome measurements were operating time, wound complication, and intraperitoneal morbidities, postoperative pain score and cosmetic result score. Results: Operating time is significantly longer in SLA ($70.4{\pm}26.7$ minutes vs. $58.0{\pm}23.4$ minutes; p=0.016). There were no significant differences in the postoperative wound complication rate and intraperitoneal morbidities between two groups. There were no significant differences in postoperative resting pain score ($6.6{\pm}2.5$ vs. $6.3{\pm}2.5$; p=0.317) and activity pain score ($6.9{\pm}2.4$ vs. $6.3{\pm}2.5$; p=0.189), and the cosmetic result score ($9.2{\pm}1.1$ vs. $9.1{\pm}1.4$; p=0.853). Conclusion: Although SLA would be a safe and feasible procedure in children, SLA could not demonstrate the clear benefit over CLA.

• Journal of Korean Neurosurgical Society
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• v.65 no.6
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• pp.772-778
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• 2022

Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

• Journal of Gastric Cancer
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• v.1 no.4
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• pp.221-227
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• 2001

Purpose: We have carried out prospective randomized clinical trial to compare survival benefit and side effect among three postoperative adjuvant chemotherapeutic regimens in serosa-negative gastric cancer patients. Materials and Methods: Total 317 cases were recognized as serosa negative and randomized into three groups at operating room. Out of them, 172 cases were excluded because of various reasons and 135 cases were analyzed finally; Group A 36 cases, Group B 49 cases, Group C 50 cases. Group A were treated with intravenous FP combination therapy, group B with MF combination therapy and group C with oral $UFT^{(R)}$ (mixture of Tegafur and Uracil) for one year. The median follow-up period was 30 months. Results: $88.9\%$ of Group A, $83.7\%$ of Group B and $90.4\%$ of Group C received adequate chemotherapy. The complication rates of Group A ($44.4\%$) was significantly higher than group B ($20.4\%$) and group C ($24.0\%$)(P<0.05). Most frequent complications were nausea and vomiting. The 3-year survival rates and disease-free survival rates were $92.2\%$ and $89.9\%$ respectively (Group A: $96.6\%,\;87.8\%$, B: $90.3\%,\;87.7\%$, C: $95.7\%,\;93.8\%$). There were no significant differences in survival rate and disease-free survival rate among the three groups (P>0.05). Conclusion: This study might suggest that the survival benefit of postoperative adjuvant chemotherapy for gastric Pseudomonas aeruginosa, and therefore it may be a useful adjunct tool for detection of Pseudomonas aeruginosa infection in combination with other conventional techniques.

• Journal of Gastric Cancer
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• v.17 no.4
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• pp.354-362
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• 2017

Purpose: Laparoscopic gastrectomy is accepted as a standard treatment for patients with early gastric cancer in Korea, Japan, and China. However, duodenal stump leakage remains a fatal complication after gastrectomy. We conducted a prospective phase II study to evaluate the safety of the new technique of laparoscopic reinforcement suture (LARS) on the duodenal stump. Materials and Methods: The estimated number of patients required for this study was 100 for a period of 18 months. Inclusion criteria were histologically proven gastric adenocarcinoma treated with laparoscopic distal or total gastrectomy and Billroth II or Roux-en-Y reconstruction. The primary endpoint was the incidence of duodenal stump leakage within the first 30 postoperative days. The secondary endpoints were early postoperative outcomes until discharge. Results: One hundred patients were enrolled between February 2016 and March 2017. The study groups consisted of 65 male and 35 female patients with a mean age (years) of 62.3. Of these, 63 (63%) patients had comorbidities. The mean number of retrieved lymph nodes was 38. The mean operation time was 145 minutes including 7.8 minutes of mean LARS time. There was no occurrence of duodenal stump leakage. Thirteen complications occurred, with one case of reoperation for splenic artery rupture and one case of mortality. Conclusions: Based on the results of this prospective phase II study, LARS can be safely performed in a short operation period without development of duodenal stump leakage. A future randomized prospective controlled trial is required to confirm the surgical benefit of LARS compared to non-LARS.

• The Korean Journal of Pain
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• v.33 no.3
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• pp.258-266
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• 2020

Background: The genicular nerve block (GNB) is demonstrated from several reports to alleviate pain and improve knee functionality in patients with chronic knee osteoarthritis (OA). Ultrasound (US)-guided GNB has been the most used imaging method. This study aimed to compare the effectiveness of US-guided versus blind GNB in the treatment of knee OA. Methods: This prospective, randomized clinical trial included patients with knee OA based on American College of Rheumatology diagnostic criteria. The patients were evaluated for clinical and dynamometer parameters at the baseline, 4 weeks after treatment, and 12 weeks after treatment. The patients underwent blind injection or US-guided injection. Results: When compared with the baseline, both groups showed significant improvement in pain, physical function, and quality of life parameters. Significant differences were observed between the groups for clinical parameters (30-second chair stand test, 6-minute walk test) in favor of the US-guided group. On the other hand, blind injection was more significantly effective on some parameters of the Nottingham Health Profile. There wasn't any significant improvement in isokinetic muscle strength for either group. Conclusions: This study demonstrated that both US-guided and blind GNB, in the treatment of knee OA, were effective in reducing symptoms and improving physical function. GNB wasn't an effective treatment for isokinetic muscle function. US-guided injections may yield more effective clinical results than blind injections.

• Archives of Plastic Surgery
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• v.48 no.6
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• pp.583-589
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• 2021

Background In prosthesis-based breast reconstruction patients, the drain tends to be kept in place longer than in patients who undergo only mastectomy. Postoperative arm exercise also increases the drainage volume. However, to preserve shoulder function, early exercise is recommended. In this study, we investigated the effect of early exercise on the total drainage volume and drain duration in these patients. Methods We designed a prospective randomized trial involving 56 patients who underwent immediate breast reconstruction following mastectomy using tissue expanders. In each group, the patients were randomized either to perform early arm exercises using specific shoulder movement guidelines 2 days after surgery or to restrict arm movement above the shoulder height until drain removal. The drain duration and the total amount of drainage were the primary endpoints. Results There were no significant differences in age, height, weight, body mass index, or mastectomy specimen weight between the two groups. The total amount of drainage was 1,497 mL in the early exercise group and 1,336 mL in the exercise restriction group. The duration until complete removal of the drains was 19.71 days in the early exercise group and 17.11 days in the exercise restriction group. Conclusions Exercise restriction after breast reconstruction did not lead to a significant difference in the drainage volume or the average time until drain removal. Thus, early exercise is recommended for improved shoulder mobility postoperatively. More long-term studies are needed to determine the effect of early exercise on shoulder mobility in prosthesis-based breast reconstruction patients.

• Biomedical Science Letters
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• v.11 no.3
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• pp.407-416
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• 2005

Cardiopulmonary bypass (CPB) for cardiac surgery induces the production and release of numerous chemotactic substances and cytokines, ensuing systemic inflammatory response that causes postoperative major organ dysfunctions. We performed a randomized, prospective study to investigate clinical effects of preoperative treated-methylprednisolone for preventing inflammation in pediatric cardiac surgery with CPB. Thirty pediatric patients scheduled for elective cardiac surgery were randomized to either control(n=15) or steroid group (n=15, 10 mg/kg of methylprednisolone). Arterial blood samples were taken before and after the operations for measuring total leukocyte (T-WBC) and differential counts, platelet counts, interleukin-6 (IL-6), myeloperoxidase (MPO), neuron specific enolase (NSE), troponin-I (TNI), aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine levels. Postoperative parameters such as pulmonary index (PI, $PaO_2/FiO_2$), 24 hrs and total bleeding volumes, mechanical ventilating (MVP) and intensive care unit (ICU)-staying periods, and hospitalization were assessed. T-WBC, neutrophil fraction, IL-6, MPO, NSE, TNI, AST and creatinine levels, bleeding volumes, PI, and MVP at the postoperative periods were lower or shorter in steroid group than in control group (P<0.05). These findings indicated that preoperative administration of methylprednisolone attenuated CPB-induced inflammatory reactions, contributing to postoperative recovery of patients underwent cardiac surgery.