• Title/Summary/Keyword: Prospective randomized trial

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Laparoscopic Reinforcement Suture (LARS) on Staple Line of Duodenal Stump Using Barbed Suture in Laparoscopic Gastrectomy for Gastric Cancer: a Prospective Single Arm Phase II Study

  • Kim, Min Chan;Kim, Sang Yun;Kim, Kwan Woo
    • 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.

Comparing the effectiveness of ultrasound guided versus blind genicular nerve block on pain, muscle strength with isokinetic device, physical function and quality of life in chronic knee osteoarthritis: a prospective randomized controlled study

  • Cankurtaran, Damla;Karaahmet, Ozgur Zeliha;Yildiz, Sadik Yigit;Eksioglu, Emel;Dulgeroglu, Deniz;Unlu, Ece
    • 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.

The effect of early arm exercise on drainage volume after total mastectomy and tissue expander insertion in breast cancer patients: a prospective study

  • Joo, Oh Young;Moon, Seung Jin;Lee, Dong Won;Lew, Dae Hyun;Lee, Won Jai;Song, Seung Yong
    • 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.

Clinical Effects of Preoperative treated-Methylprednisolone in Pediatric Cardiac Surgery with Cardiopulmonary Bypass

  • Choi Seok-Cheol;Kim Yang-Weon;Jang Jung Hoon
    • 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.

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Comparative evaluation of efficacy of Physics Forceps versus conventional forceps in pediatric dental extractions: a prospective randomized study

  • Elicherla, Sainath Reddy;Bandi, Sujatha;Nunna, Mahesh;Saikiran, Kanamarlapudi Venkata;Sahithi, Varada;Nuvvula, Sivakumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.547-556
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    • 2021
  • Background: This study aimed to determine the efficacy of Physics Forceps in pediatric dental extractions. Methods: This was a double-blind, randomized controlled trial with a parallel-arm design and identical allocation ratio (1:1). Children (n=104) were randomly divided into two groups for extraction of mandibular primary teeth (group I: Physics Forceps; group II: conventional forceps). The outcome variables assessed in the study were the time taken for extraction, pre- and postoperative anxiety (using RMS pictorial scale), incidence of fractured teeth, and postoperative pain on the first and third days (using the Wong-Baker faces pain scale). Results: A significant reduction (P < 0.001) in intraoperative time, anxiety, and incidence of tooth fracture was confined to group I. The pain significantly reduced from the first to the third postoperative day in both groups, but the mean reduction in RMS scores in the physics forceps group was far better than that in the conventional forceps group. Conclusion: Physics Forceps aid in extraction of primary teeth with minimal trauma to supporting structures, as well as reducing anxiety in the pediatric population.

The Effect of Sa-am acupuncture on Knee Osteoarthritis

  • Min, Moo-Hong;Choi, Yeong-Gon;Kim, Yun-Ju;Park, Hi-Joon;Lee, Sam-Chool;Joo, Ho-No;Han, Seung-Moo;Lim, Sa-Bi-Na
    • Korean Journal of Acupuncture
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    • v.26 no.4
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    • pp.53-66
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    • 2009
  • Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.

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IORT in Gastric Cancer (위암의 수술중 방사선 치료)

  • Kim Myung Se;Kang Cheol Hoon;Kim Sung Kyu;Song Sun Kyo;Kwan Koing Bo;Kim Heung Dae
    • Radiation Oncology Journal
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    • v.9 no.1
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    • pp.87-91
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    • 1991
  • Total 28 patients with resectable, locally advanced gastric cancer were entered in our prospective randomized study from June 15, 1988 to Sep. 15, 1990 in Yeungnam University Hospital. This study consisted of curative resection, IORT, external irradiation and combination of chemotherapy. Twenty-four of 28 patients were treated with single dose of 1500 cGy with 9 MeV election intraoperatively. External irradiation of $4300\sim4500$ cGy with 180 cGy per fraction, 5 days per week was started within 4th weeks of postoperative days. Various chemotherapy with or without external irradiation were added for reducing hematogenous and/or peritoneal dissemination and determination of complication of each arm. Duration of follow up was $4\sim31$ months. No serious complication related with radiation were reported compare to resection and chemotherapy only group. Although our follow up period is too short to draw any conclusion, IORT appears to improve local control, hopely further survival. Continuous follow up should be needed for evaluation of real therapeutic gain such as complication vs. improved survival.

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The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study (급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검)

  • Song, Ho-Seub
    • Journal of Pharmacopuncture
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    • v.8 no.2
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    • pp.11-16
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    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

Clinical evaluation of efficacy of transcortical anesthesia for the extraction of impacted mandibular third molars: a randomized controlled trial

  • Demir, Esin;Ataoglu, Hanife
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.1
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    • pp.9-17
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    • 2020
  • Background: This study aimed to compare the pain levels during anesthesia and the efficacy of the QuickSleeper intraosseous (IO) injection system and conventional inferior alveolar nerve block (IANB) in impacted mandibular third molar surgery. Methods: This prospective randomized clinical trial included 30 patients (16 women, 14 men) with bilateral symmetrical impacted mandibular third molars. Thirty subjects randomly received either the IO injection or conventional IANB at two successive appointments. A split-mouth design was used in which each patient underwent treatment of a tooth with one of the techniques and treatment of the homologous contralateral tooth with the other technique. The subjects received 1.8 mL of 2% articaine. Subjects' demographic data, pain levels during anesthesia induction, tooth extractions, and mouth opening on postoperative first, third, and seventh days were recorded. Pain assessment ratings were recorded using the 100-mm visual analog scale. The latency and duration of the anesthetic effect, complications, and operation duration were also analyzed in this study. The duration of anesthetic effect was considered using an electric pulp test and by probing the soft tissue with an explorer. Results: Thirty patients aged between 18 and 47 years (mean age, 25 years) were included in this study. The IO injection was significantly less painful with lesser soft tissue numbness and quicker onset of anesthesia and lingual mucosa anesthesia with single needle penetration than conventional IANB. Moreover, 19 out of 30 patients (63%) preferred transcortical anesthesia. Mouth opening on postoperative first day was significantly better with intraosseous injection than with conventional IANB (P = 0.013). Conclusion: The IO anesthetic system is a good alternative to IANB for extraction of the third molar with less pain during anesthesia induction and sufficient depth of anesthesia for the surgical procedure.

A prospective randomized trial of xylometazoline drops and epinephrine merocele nasal pack for reducing epistaxis during nasotracheal intubation

  • Patel, Sonam;Hazarika, Amarjyoti;Agrawal, Prachi;Jain, Divya;Panda, Naresh Kumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.4
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    • pp.223-231
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    • 2020
  • Background: The most frequent complication of nasotracheal intubation (NTI) is epistaxis. Epinephrine nasal gauze packing has been used conventionally as a pre-treatment for reducing epistaxis, but it carries a disadvantage of pain and anxiety in patients. However, xylometazoline drops are easier to administer and more convenient for patients. We aimed at comparing the effectiveness of xylometazoline drops and epinephrine merocele packing in reducing bleeding and postoperative complications in our population. Methods: Our study enrolled 120 patients in a double-blind randomized controlled trial. We randomly allocated ASA1 or 2 adult patients into 2 groups: Group X and Group E. Group X received 0.1% xylometazoline nasal drops, and epinephrine (1:10,000) merocele nasal packing was used in Group E. The primary outcome was the incidence of bleeding during NTI; the severity of bleeding, navigability, bleeding during extubation, and postoperative complications were secondary outcomes. We used IBM SPSS and Minitab software for statistical analysis, and P < 0.05 was considered statistically significant. Results: We analyzed the data of 110 patients: 55 in Group X and 55 in Group E. The two groups did not have different bleeding incidence (56.4% vs 60.0%; P = 0.70); however, the incidence of severe bleeding was less with xylometazoline than with epinephrine (3.63% vs 14.54%; P < 0.05). We also observed less bleeding during extubation (38.2% vs 68.5%; P < 0.05) with xylometazoline. Other secondary outcomes were akin to both groups. Conclusion: The incidence of severe and post-extubation bleeding was significantly less with xylometazoline. Hence, it may be an effective alternative for reducing the incidence and severity of epistaxis during NTI.