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The learning curve of the distal radial access for coronary intervention
2021
Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial access (DRA), are gaining attention owing to fewer complications. Despite the advantages of the DRA, there is difficulty to initiate this new vascular approach. The data from 1000 patients who underwent CAG and PCI via the DRA by a single experienced radial operator were retrospectively analyzed. The primary outcome was the success rate of the DRA per 100 cases. Moreover, the predictors of the failed DRA were analyzed. Overall, 952 (95.2%) of the total 1,000 patients underwent a successful DRA. After experiencing 200 cases, the DRA success rate was well maintained at > 94%, and there was no difference in success rate per 100 cases (
P
trend
= 0.216). The predictors of failure were female sex [odds ratio (OR) 1.84, 95% confidence interval (CI) 1.01–3.39,
P
= 0.049] and systolic blood pressure (SBP) of < 120 mmHg (OR 1.87, 95% CI 1.04–3.36,
P
= 0.036). For achieving a stable DRA with the success rate of > 94%, 200 procedures would be needed. Moreover, this new approach could fail in women and patients with low SBP.
Trial registration:
https://cris.nih.go.kr/cris/index/index.do
(Unique identifier: KCT0005349).
Journal Article
Advances in methylation analysis of liquid biopsy in early cancer detection of colorectal and lung cancer
2023
Methylation patterns in cell-free DNA (cfDNA) have emerged as a promising genomic feature for detecting the presence of cancer and determining its origin. The purpose of this study was to evaluate the diagnostic performance of methylation-sensitive restriction enzyme digestion followed by sequencing (MRE-Seq) using cfDNA, and to investigate the cancer signal origin (CSO) of the cancer using a deep neural network (DNN) analyses for liquid biopsy of colorectal and lung cancer. We developed a selective MRE-Seq method with DNN learning-based prediction model using demethylated-sequence-depth patterns from 63,266 CpG sites using
Sac
II enzyme digestion. A total of 191 patients with stage I–IV cancers (95 lung cancers and 96 colorectal cancers) and 126 noncancer participants were enrolled in this study. Our study showed an area under the receiver operating characteristic curve (AUC) of 0.978 with a sensitivity of 78.1% for colorectal cancer, and an AUC of 0.956 with a sensitivity of 66.3% for lung cancer, both at a specificity of 99.2%. For colorectal cancer, sensitivities for stages I–IV ranged from 76.2 to 83.3% while for lung cancer, sensitivities for stages I–IV ranged from 44.4 to 78.9%, both again at a specificity of 99.2%. The CSO model's true-positive rates were 94.4% and 89.9% for colorectal and lung cancers, respectively. The MRE-Seq was found to be a useful method for detecting global hypomethylation patterns in liquid biopsy samples and accurately diagnosing colorectal and lung cancers, as well as determining CSO of the cancer using DNN analysis.
Trial registration: This trial was registered at ClinicalTrials.gov (registration number: NCT 04253509) for lung cancer on 5 February 2020,
https://clinicaltrials.gov/ct2/show/NCT04253509
. Colorectal cancer samples were retrospectively registered at CRIS (Clinical Research Information Service, registration number: KCT0008037) on 23 December 2022,
https://cris.nih.go.kr
,
https://who.init/ictrp
. Healthy control samples were retrospectively registered.
Journal Article
Prospective comparative analysis of three types of decompressive surgery for lumbar central stenosis: conventional, full-endoscopic, and biportal endoscopic laminectomy
2024
Conventional open laminectomy has long been considered one of the important surgical options for lumbar central stenosis owing to its positive outcomes. However, newer approaches have emerged as alternatives, including full-endoscopic and biportal endoscopic laminectomy. Therefore, a comparison of the outcomes that are associated with each of these surgical methods is warranted. This prospective multicenter trial, initiated in February 2019, compared the outcomes of three lumbar central stenosis surgical approaches: open laminectomy (OPEN), uniportal endoscopy (UNIPORT), and biportal endoscopy (BIPORT). Among 115 participants from seven centers, one-year follow-ups assessed laboratory, radiological, and clinical outcomes. Despite all groups showing adequate decompression and clinical improvement, the OPEN group exhibited less improvement in Visual analog scale (VAS) for back pain scores (p < 0.05) and significant postoperative increases in most laboratory markers. Furthermore, the OPEN group experienced a significant decrease in multifidus muscle cross-sectional area compared to endoscopic groups (p < 0.001). Each surgical techniques produced similar clinical outcomes and dural space expansion. However, endoscopic surgery was associated with better muscle preservation and better relief of back pain. Endoscopic surgery is a reasonable alternative to conventional laminectomy for treating lumbar central stenosis.
This trial was registered on CRIS (Clinical Research Information Service, KCT0004355).
Journal Article
Video augmented mirror therapy for upper extremity rehabilitation after stroke: a randomized controlled trial
2023
Purpose
To investigate the effects of mirror therapy using a newly developed video augmented wearable reflection device on reach-to-grasp motor control and upper extremity motor function.
Methods
Participants were randomly allocated to one of three groups: mirror therapy using a video augmented wearable reflection device group (MTVADG),
n
= 12; traditional mirror therapy group (TMTG),
n
= 12; and control group (CG),
n
= 12. Participants in the MTVADG and TMTG received conventional rehabilitation in addition to mirror therapy. Motor control during the reach-to-grasp movement was assessed using kinematic analysis. Each participant’s upper extremity motor function was assessed using the Fugl-Meyer Assessment, Manual Function Test, and Box and Block Test.
Results
While both the MTVADG and TMTG showed significantly improved reach-to-grasp movement. The MTVADG showed greater efficiency in kinematic performance than the TMTG. Moreover, while both the MTVADG and TMTG showed improved upper extremity motor function, the MTVADG showed significantly greater improvement in proximal upper limb function compared to the TMTG.
Conclusion
Our results suggested that mirror therapy using a video augmented wearable reflection device is more efficient compared to traditional mirror therapy for patients with stroke.
Clinical trial registration unique identifier
KCT0003047.
Journal Article
Vitamin C supplementation promotes mental vitality in healthy young adults: results from a cross-sectional analysis and a randomized, double-blind, placebo-controlled trial
by
Hong Sehwa
,
Dong-Mi, Shin
,
Sim Minju
in
Ascorbic acid
,
Blindness
,
Brain-derived neurotrophic factor
2022
PurposeWe aimed to investigate the link of vitamin C status with vitality and psychological functions in a cross-sectional study, and examine their causal relationship through a randomized controlled trial (RCT).MethodsWe first conducted a population-based cross-sectional investigation of healthy young adults (n = 214, 20–39 years), and analyzed the associations of serum vitamin C concentrations with vitality (fatigue and attention) and mood status (stress, depression, and positive and negative affect) using Pearson’s correlation and multiple linear regression analyses. Next, we performed a double-blind RCT in healthy subjects whose serum vitamin C concentrations were inadequate (< 50 μmol/L). Subjects were randomly allocated to receive 500 mg of vitamin C twice a day for 4 weeks (n = 24) or a placebo (n = 22). We assessed vitality, which included fatigue, attention, work engagement, and self-control resources, and measured mood status, including stress, depression, positive and negative affect, and anxiety. ELISA determined serum brain-derived neurotrophic factor (BDNF), and a Stroop color–word test evaluated attention capacity and processing speed.ResultsIn the cross-sectional data, the serum vitamin C concentration was positively associated with the level of attention (r = 0.16, p = 0.02; standardized β = 0.21, p = 0.003), while no significant associations with the levels of fatigue and mood variables being found. In the RCT, compared to the placebo, the vitamin C supplementation significantly increased attention (p = 0.03) and work absorption (p = 0.03) with distinct tendency of improvement on fatigue (p = 0.06) and comprehensive work engagement (p = 0.07). The vitamin C supplementation did not affect mood and serum concentrations of BDNF. However, in the Stroop color–word test, the subjects supplemented with vitamin C showed better performance than those in the placebo group (p = 0.04).ConclusionInadequate vitamin C status is related to a low level of mental vitality. Vitamin C supplementation effectively increased work motivation and attentional focus and contributed to better performance on cognitive tasks requiring sustained attention.Trial registration number and date of registrationCross-sectional study: KCT0005074 (cris.nih.go.kr)/1 June, 2020 (retrospectively registered). Intervention study: KCT0004276 (cris.nih.go.kr)/4 September, 2019.
Journal Article
Anxiolytic effects of chewing gum during preoperative fasting and patient-centered outcome in female patients undergoing elective gynecologic surgery: randomized controlled study
2022
Although previous studies reported that chewing gum during the preoperative fasting has the benefits of alleviating anxiety and dry mouth, preoperative chewing gum has yet to be accepted as a standard practice due to conventional anesthetic custom. Our study aimed to prospectively evaluate the effects of gum chewing on preoperative anxiety and patient’s discomfort in female patients undergoing gynecologic surgery. Ninety-four patients were enrolled and randomized either into conventional fasting group (control group) or chewing gum with fasting group (gum group). The control group was instructed to fast from 3 p.m. on the day before surgery. The gum group performed preoperative fasting in the same manner, but was encouraged to chew gum freely during the fasting period. The primary endpoint was the degree of preoperative anxiety. For the evaluation of preoperative anxiety, Amsterdam preoperative anxiety and information scale (APAIS) was used. Preoperative gastric fluid volume and acidity were also measured as the secondary outcomes. Preoperative anxiety using APAIS was significantly lower in the gum group compared to the control group (control group vs. gum group: 20.9 vs. 17.8,
p
= 0.009). However, there was no significant difference in the gastric fluid analysis between the groups. In the female patients for elective gynecologic surgery, chewing gum during the preoperative fasting period helped to alleviate preoperative anxiety without additional increase of pulmonary aspiration risks.
Trial registration
: KCT0004422 (05/11/2019,
https://cris.nih.go.kr
; registration number).
Journal Article
Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock
2024
The benefits of intravascular ultrasonography (IVUS)-guided percutaneous coronary intervention (PCI) in the clinical context of cardiogenic shock (CS) complicating acute myocardial infarction are lacking. We aimed to investigate the impact of IVUS-guided PCI in patients with AMI and CS. From the pooled data based on a series of Korean AMI registries during 2011–2020, we identified 1418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. In total, 294 (20.7%) and 1124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. The 1-year TLF was not significantly different between groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65–1.34, p = 0.70). Additionally, the adjusted landmark analysis for TLF at 30 days and between 30 days and 1 year after PCI demonstrated no significant difference between the groups. In conclusion, in patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve the 1-year TLF compared with angiography-guided PCI.
Registration:
URL:
http://cris.nih.go.kr
. KCT0000863 and KCT0008355.
Journal Article
The arousal effect of sugammadex reversal of neuromuscular blockade differs with anesthetic depth in propofol-remifentanil anesthesia: a randomized controlled trial
2023
Sugammadex reverses neuromuscular blockade by encapsulating steroidal neuromuscular blockers; therefore, it does not pharmacologically affect sedation levels. However, some clinicians avoid using it because of sudden unwanted acting out or patient arousal. Previous studies suggested sugammadex-induced awakening, but frontal muscle contraction after sugammadex administration compromised reliability of results obtained from EEG-based anesthesia depth monitoring tools like bispectral index (BIS). We hypothesized that sugammadex would affect patients’ arousal depending on their baseline levels of sedation. We evaluated arousal signs after sugammadex administration with BIS between 25 − 35 and 45 − 55 under steady-state propofol-remifentanil anesthesia at the end of a surgery (n = 33 in each group). After sugammadex administration, twelve patients with a BIS of 45 − 55 showed clinical signs of awakening but none with a BIS of 25 − 35 (36.4% vs. 0%,
P
= 0.001). The distribution of the modified observer’s assessment of alertness/sedation scale scores was also significantly different between the two groups (
P
< 0.001). Changes in the BIS were significantly greater in the BIS 45 − 55 than in the 25 − 35 group (median difference, 7; 95% CI 2 − 19,
P
= 0.002). Arousal after sugammadex was affected by patient sedation levels, and clinical signs of awakening appeared only in those with BIS 45 − 55. Unwanted arousal of the patient should be considered when using sugammadex under shallow anesthesia.
Clinical trial registry number:
Clinical Trial Registry of Korea (
https://cris.nih.go.kr
; Principal investigator: Jieae Kim; Registration number: KCT0006248; Date of first registration: 11/06/2021).
Journal Article
Intraoperative use of dexmedetomidine for the prevention of emergence agitation and postoperative delirium in thoracic surgery: a randomized-controlled trial
by
Seong, Bong Gyu
,
Ahn, Hyun Joo
,
Jeong, Heejoon
in
Anesthesia
,
Catecholamines
,
Clinical trials
2019
PurposeWe investigated whether preventive use of dexmedetomidine during surgery was effective for reducing emergence agitation and postoperative delirium.MethodsIn this double-blind randomized-controlled trial, 143 patients undergoing thoracoscopic lung resection surgery were randomly assigned to the dexmedetomidine-sevoflurane (DEX-Sevo, n = 73) or sevoflurane (Sevo, n = 70) groups. Dexmedetomidine or saline administration was started after inducing anesthesia and continued until the end of surgery at a fixed dose (0.5 µg·kg−1·hr−1). The primary endpoint was the incidence of delirium up until the end of postoperative day 3. Emergence agitation and postoperative delirium were measured with the Riker sedation agitation scale and the confusion assessment method, respectively. The secondary endpoints were serum cytokine and catecholamine levels.ResultsThe DEX-Sevo group showed less frequent emergence agitation than the Sevo group (13% vs 35%, respectively; relative risk, 0.38; 95% confidence interval [CI], 0.18 to 0.79; P = 0.011) but the incidence of delirium after discharge from the postanesthesia care unit was not different (25% vs 25%, DEX-Sevo vs Sevo). Both pro- and anti-inflammatory cytokines were lower in the DEX-Sevo group than in the Sevo group. Nevertheless, the interleukin (IL)6/IL10 ratio (median difference, 5.8; 95% CI,1.8 to 10.0; P = 0.012) and IL8/IL10 ratio (median difference, 0.8; 95% CI, 0.2 to 1.3; P = 0.007) were higher in the DEX-Sevo group than in the Sevo group, indicating a pro-inflammatory cytokine balance in the DEX-Sevo group. Norepinephrine and epinephrine levels were lower in the DEX-Sevo group than in the Sevo group (both, P < 0.001).ConclusionsIntraoperative dexmedetomidine reduced emergence agitation but not postoperative delirium in patients undergoing thoracic surgery. Dexmedetomidine seemed to affect emergence agitation through catecholamines, but not through an anti-inflammatory action.Trial registration Clinical Research Information Service (KCT 0001877); registered 7 April, 2016.
Journal Article
Comparison of the Analgesic Efficacy of Opioid-Sparing Multimodal Analgesia and Morphine-Based Patient-Controlled Analgesia in Minimally Invasive Surgery for Colorectal Cancer
by
Kim, Hye Jin
,
Park, Soo Yeun
,
Kim, Jay Kyoung
in
Abdominal Muscles
,
Abdominal Surgery
,
Analgesia
2022
Background
A multimodal analgesia (MMA) protocol has shown the effect of postoperative pain control and reduced the postoperative opioid consumption. However, it was questionable whether MMA could replace opioid-based patient-controlled analgesia (PCA) for postoperative pain control. Therefore, this study aimed to investigate whether an MMA protocol is non-inferior to opioid-based PCA for pain management after a minimally invasive colorectal cancer surgery.
Methods
A randomized, open-label, non-inferiority clinical trial was conducted on patients undergoing laparoscopic or robotic resection of colorectal cancer. The patients were randomly assigned to either the PCA or MMA group. The MMA protocol included pregabalin, tramadol, wound infiltration, and transversus abdominis plane block. The primary outcome was the numeric rating scale (NRS) score for pain at rest 24 h postoperatively.
Results
Ninety-seven patients were included in the intention-to-treat analysis. The mean difference in NRS score at rest at 24 h was 0.25 (95% confidence interval, − 0.61 to 1.11). This result demonstrated the non-inferiority of MMA to PCA in our non-inferiority margin (− 1). Compared with the PCA group, the median remifentanil dose (996 vs. 654 μg;
p
< 0.001) and time in the post-anesthesia care unit (35 vs. 25 min;
p
< 0.001) were significantly less in the MMA group.
Conclusions
Our MMA protocol successfully controlled postoperative pain and was non-inferior to morphine-based PCA based on patient-reported pain intensity, with no significant increase in adverse events. These results will help construct a strategy to reduce conventional opioid prescriptions for pain management after a minimally invasive colorectal cancer surgery.
Trial Registration Number
Trial Registration Clinical Research Information Service Identifier: KCT0002593
Journal Article