Bio-integrative vs Metallic Screws in Calcaneus Osteotomies: A Non-Inferiority Randomized Clinical Trial
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PROVIDER: S-EPMC10748924 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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Project description:Background/objectivesStandard sub-Tenon's block (STB) involves incision (dissection) of conjunctiva and Tenon's capsule with the help of blunt scissors and forceps, insertion of a blunt sub-Tenon's cannula under the Tenon's capsule and injection of local anaesthetic agent. STB is frequently associated with minor complications such as chemosis and postoperative subconjunctival haemorrhage but rare sight and life-threatening complications. To reduce these minor complications, several variations of incisionless STB have been described however, there are no comparative data. One such incisionless STB involves the use of lacrimal dilator which is easily available in the operating theatre. We compared incisionless lacrimal dilator-facilitated with the standard STB for effectiveness, chemosis, and postoperative subconjunctival haemorrhage.Subjects/methodsAfter obtaining ethical approval, patients scheduled to undergo elective phacoemulsification cataract surgery were enroled to receive incisionless lacrimal dilator-facilitated STB (Group LD) or a standard STB using Wescott scissors and blunt forceps (Group WS). All patients received 3 mL 2% lidocaine without any adjuvant. No sedation was administered. Demographics of the patients, duration of the procedure, analgesia, akinesia, duration of the procedure intraoperative chemosis, and postoperative subconjunctival haemorrhage were compared.ResultsBoth groups were comparable for demographic data, duration of the procedure, analgesia, and akinesia (p > 0.05). The severity of chemosis and postoperative subconjunctival haemorrhage were significantly lower in Group LD (n = 32) in comparison to Group WS (n = 31) (p < 0.001).ConclusionsIncisionless lacrimal dilator-facilitated STB decreases intraoperative chemosis and postoperative conjunctival haemorrhage in comparison to standard STB. Analgesia and akinesia are comparable in both techniques.
| S-EPMC8225894 | biostudies-literature
Project description:PurposeHolmium laser enucleation of the prostate (HoLEP) represents the current standard procedure for size-independent surgical therapy of benign prostatic obstruction (BPO). With advent of the novel laser technology thulium fiber laser (TFL), we hypothesized that the functional outcome of TFL enucleation of the prostate (ThuFLEP) is non-inferior compared to HoLEP.MethodsFrom October 2021 to October 2022, 150 patients with BPO were recruited for the prospective randomized trial in accordance with CONSORT. Stratified randomization into the arms ThuFLEP (n = 74) or HoLEP (n = 76) was carried out. The primary endpoint was non-inferior international prostate symptom score (IPSS) and quality of life (QoL) at three months after treatment. Secondary endpoints were rates of complications, peak flow, residual urine and operation times.ResultsPreoperative characteristics showed no significant differences. Overall IPSS and QoL improved from 21 to 8 and 4 to 1.5, respectively, after three months of follow-up. No statistically significant differences between ThuFLEP and HoLEP were observed regarding median postoperative IPSS (8.5 vs. 7, p > 0.9), QoL (1 vs. 2, p = 0.6), residual urine (48 vs. 30ml, p = 0.065) and peak flow (19 vs. 17ml/s, p > 0.9). Similarly, safety profile was comparable with no statistically significant differences regarding rate of major complications (5.3 vs. 5.4%, p = 0.5), laser hemostasis time (3 vs. 2min, p = 0.2), use of additive electric coagulation (74 vs. 87%, p = 0.06) or electric coagulation time (8 vs. 8min, p = 0.4).ConclusionsIn this prospective, randomized trial ThuFLEP showed non-inferior results compared to HoLEP in terms of functional outcomes measured by IPSS and QoL as primary endpoint.Trial registration numberDRKS00032699 (18.09.2023, retrospectively registered).
| S-EPMC10799774 | biostudies-literature
Project description:AimsDrug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 μg/mm2.Methods and resultsWithin a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred.ConclusionTwo DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths.Clinical trial registrationThe trial is registered with ClinicalTrials.gov (NCT02701543).
| S-EPMC7360381 | biostudies-literature
Project description:Background: Currently, the first line treatment of persistent ductus arteriosus (PDA) is either indomethacin or ibuprofen. However, the potentially life-threatening side effects associated to their use have prompted physicians to look for alternative options. The incorporation of paracetamol as an alternative to ibuprofen in the management of PDA is still based on insufficient clinical evidence. Hence, more clinical trials are needed to establish a therapeutic role for paracetamol in the management of PDA that take into consideration short- and long-term safety and efficacy outcomes. Study Design: This is a non-inferiority, randomized, multicenter, double-blinded study to evaluate the efficacy, and safety of intravenous (IV) paracetamol vs. IV ibuprofen (standard treatment) for PDA in preterm patients with a gestational age ≤ 30 weeks. At baseline, patients will be randomized (1:1) to treatment with paracetamol or ibuprofen. The primary endpoint is closure of the ductus after the first treatment course. Secondary endpoints are related to effectiveness (need for a second treatment course, rescue treatment, reopening rate, time to definitive closure, need for surgical ligation), safety (early and long-term complications), pharmacokinetics, and pharmacodynamics, pharmacogenetics, pharmacoeconomics, and genotoxicity. Long-term follow-up to 24 months of corrected postnatal age will be performed using Bayley III neurodevelopmental scale. Trial Registration: ClinicalTrials.gov Identifier: NCT04037514. EudraCT: 2015-003177-14.
| S-EPMC7380081 | biostudies-literature
Project description:BackgroundProcedural sedation is essential for optimizing upper gastrointestinal endoscopy, particularly in high-risk patients with multiple underlying diseases. Respiratory and circulatory complications present significant challenges for procedural sedation in this population. This non-inferiority randomized controlled trial aims to investigate the safety and comfort of remimazolam compared to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients.MethodsA total of 576 high-risk patients scheduled to undergo upper gastrointestinal endoscopy are planned to be enrolled in this study and randomly allocated to either the remimazolam or propofol group. The primary outcome measure is a composite endpoint, which includes (1) achieving a Modified Observer's Alertness/Sedation scale (MOAA/S) score ≤ 3 before endoscope insertion, (2) successful completion of the endoscopic procedure, (3) the absence of significant respiratory instability during the endoscopy and treatment, and (4) the absence of significant circulatory instability during the examination. The noninferiority margin was 10%. Any adverse events (AEs) that occur will be reported.DiscussionThis trial aims to determine whether remimazolam is non-inferior to propofol for procedural sedation during upper gastrointestinal endoscopy in high-risk patients, regarding success rate, complication incidence, patient comfort, and satisfaction. TRIAL REGISTRATION {2A AND 2B}: Chinese Clinical Trial Registry ClinicalTrials.gov ChiCTR2200066527. Registered on 7 December 2022.
| S-EPMC10821577 | biostudies-literature
Project description:Cognitive behavioral group therapy (CBGT) is an effective, well-established, but not widely available treatment for social anxiety disorder (SAD). Internet-based cognitive behavior therapy (ICBT) has the potential to increase availability and facilitate dissemination of therapeutic services for SAD. However, ICBT for SAD has not been directly compared with in-person treatments such as CBGT and few studies investigating ICBT have been conducted in clinical settings. Our aim was to investigate if ICBT is at least as effective as CBGT for SAD when treatments are delivered in a psychiatric setting.We conducted a randomized controlled non-inferiority trial with allocation to ICBT (n=64) or CBGT (n=62) with blinded assessment immediately following treatment and six months post-treatment. Participants were 126 individuals with SAD who received CBGT or ICBT for a duration of 15 weeks. The Liebowitz Social Anxiety Scale (LSAS) was the main outcome measure. The following non-inferiority margin was set: following treatment, the lower bound of the 95 % confidence interval (CI) of the mean difference between groups should be less than 10 LSAS-points.Both groups made large improvements. At follow-up, 41 (64%) participants in the ICBT group were classified as responders (95% CI, 52%-76%). In the CBGT group, 28 participants (45%) responded to the treatment (95% CI, 33%-58%). At post-treatment and follow-up respectively, the 95 % CI of the LSAS mean difference was 0.68-17.66 (Cohen's d between group=0.41) and -2.51-15.69 (Cohen's d between group=0.36) favoring ICBT, which was well within the non-inferiority margin. Mixed effects models analyses showed no significant interaction effect for LSAS, indicating similar improvement across treatments (F=1.58; df=2, 219; p=.21).ICBT delivered in a psychiatric setting can be as effective as CBGT in the treatment of SAD and could be used to increase availability to CBT.ClinicalTrials.gov NCT00564967.
| S-EPMC3070741 | biostudies-literature
Project description:IntroductionThe substitution of reference drugs for similar, new or existing drugs in the market is a dilemma present in daily dental procedures. In order to decide whether or not to adopt a new drug in relation to the reference, a clinical trial can provide the necessary evidence.MethodsA total of 179 healthy volunteers (18-25 years) requiring extraction of mandibular third molars completed the study. Subjects were randomized into 4 groups: right, left, Arteek-SP and Septanest. Allocations consisted of 4% Articaine hydrochloride with 1:10000 epinephrine. The primary aim of this randomized controlled trial was to determine whether the test drug Arteek-SP was noninferior by a margin of 10% in the proportion of patients with total absence of pain, compared to the reference drug Septanest in the extraction of mandibular third molars using inferior alveolar nerve blocks. Secondary outcomes included, hemodynamic parameters, volume (mL), pain scores assessed during one visit and reported postoperative discomfort assessed during 8 days. Noninferiority was declared if total absence of pain for both groups was equal to 0.9, with a significance level of 5% (P < 0.05) and power at 90% (β = 0.1) at 95% confidence level.ResultsArteek-SP was applied during the first surgery to 90 volunteers (50.28%) and Septanest was applied to 89 subjects (49.72%). Less than 10% difference was identified, in the proportion of patients with total absence of tooth pain P < 0.05 and in the gum P < 0.1, at 95% CI, when Arteek-SP was applied first in comparison with Septanest, establishing noninferiority.ConclusionThe clinical performance of the test drug Arteek-SP is noninferior to the reference drug Septanest. They can be considered interchangeable in terms of cost or convenience.RegistrationClinicalTrials.org, number NCT4166890.
| S-EPMC8233148 | biostudies-literature
Project description:The efficacy of antibiotic therapy for group A streptococcus (GAS) pharyngitis is debated. The role of antibiotics in preventing complications seems limited, with the main potential benefit being symptom duration reduction. Our study aimed to evaluate whether a placebo is non-inferior to amoxicillin in reducing fever duration. We randomized 88 children between 3 and 15 years of age presenting with acute symptoms of pharyngitis and a positive rapid antigen detection test for GAS to receive 6-day treatment with either placebo (n = 46) or amoxicillin (n = 42). The primary outcome was the difference in fever duration, with a non-inferiority threshold set at 12 h. The secondary outcomes included pain intensity and complications of streptococcal pharyngitis. The mean difference in fever duration between the amoxicillin and placebo groups was 2.0 h (95% CI, - 8.3 to 12.3) in the per-protocol analysis and 2.8 h (95% CI, - 6.5 to 12.2) in the intention-to-treat analysis. Treatment failure was observed in six participants in the placebo group and two in the amoxicillin group (relative risk, 2.15; 95% CI, 0.44-10.57). All patients were identified early and recovered well. There was no clinically relevant difference in pain intensity between groups over the 7 days following randomization, with the largest difference of 0.5 (95% CI, - 0.62-1.80) observed on day 3.ConclusionPlacebo appears to be non-inferior to amoxicillin in reducing fever duration. Pain intensity and risk of complications were similar between the two groups. These findings support the restrictive antibiotic treatment for streptococcal pharyngitis.What is known• Group A streptococcus pharyngitis is a common reason for prescribing antibiotics in pediatric care. • In high-income countries, while antibiotic treatment has not been effective in preventing non-suppurative complications, the primary justification for their use remains the reduction of symptoms.What is new• Our results suggest that antibiotics have a limited impact on the duration of fever and the intensity of pain in children with streptococcal pharyngitis. • Considering that suppurative complications can be promptly treated if they arise, we recommend a more judicious approach to antibiotic prescriptions.Trial registrationThe trial is registered at the US National Institutes of Health (ClinicalTrials.gov) # NCT03264911 on 15.08.2017.
| S-EPMC11473506 | biostudies-literature
Project description:BackgroundA disposable upper gastrointestinal endoscope can effectively decrease infectious outbreaks associated with endoscope reuse. In the present study, we aimed to evaluate the feasibility and safety of a disposable endoscope for upper gastrointestinal examination.MethodsIn a prospective, randomized trial, 144 upper endoscopic procedures were allocated to either the disposable endoscope group or the conventional endoscope group. The primary outcomes were rates of excellent and good image qualities and maneuverability satisfaction. The second outcome included procedure duration, endoscopic diagnosis, and adverse events.ResultsA total of 144 subjects were enrolled in the present analysis and prospectively randomized to 2 study groups. Finally, 70 and 69 subjects were enrolled in the novel disposable endoscope group and the conventional endoscope group, respectively, due to the schedule cancellation of 5 subjects. The baseline characteristics of the patients were similar in both groups. The excellent and good image quality rates and maneuverability satisfaction of the novel disposable endoscope were not inferior to the conventional endoscope (p = 0.99 and p = 0.99, respectively). Moreover, no significant between-group difference was observed in the endoscopic results and adverse events (p = 0.30 and p = 1, respectively). However, the procedure duration in the novel disposable endoscope was longer compared with the conventional endoscope (8.40 ± 4.28 min vs. 5.12 ± 2.65 min, p < 0.001).ConclusionsThe novel disposable endoscope was as safe, effective, and maneuverable as a conventional endoscope. However, the novel disposable endoscope was associated with a longer procedure duration.
| S-EPMC9477113 | biostudies-literature
Project description:Background and study aims In colonoscopy, preparation is often regarded as the most burdensome part of the intervention. Traditionally, specific diets have been recommended, but the evidence to support this policy is insufficient. The aim of this study was to evaluate the impact of the decision not to follow a restrictive diet on bowel preparation and colonoscopy outcomes. Patients and methods This was a multicenter, controlled, non-inferiority randomized trial with FIT-positive screening colonoscopy. The subjects were assigned to follow the current standard (1-day low residue diet [LRD]) or a liberal diet. The allocation was balanced for the risk of inadequate cleansing using the Dik et al. score. All participants received the same instructions for morning colonoscopy preparation. The primary outcome was the rate of adequate preparations as defined by the Boston Bowel Preparation Scale. Secondary outcomes included tolerability and measures of colonoscopy performance and quality. Results A total of 582 subjects were randomized. Of these, 278 who received the liberal diet and 275 who received the 1-day LRD were included in the intent-to-treat analysis. Non-inferiority was demonstrated with adequate preparation rates of 97.8% in the 1-day LRD and 96.4% in the liberal diet group. Tolerability was higher with the liberal diet (94.7% vs. 83.2%). No differences were found with respect to cecal intubation time, aspirated volume, or length of the examination. Global and right colon average adenoma detection rates per colonoscopy were similar. Conclusions The liberal diet was non-inferior to the 1-day LRD, and increased tolerability. Colonoscopy performance and quality were not affected. (NCT05032794).
| S-EPMC10919995 | biostudies-literature