ObjectiveTo systematically review efficacy of endoscopic ultrasonography guided biliary drainage (EUS-BD) and percutaneous transhepatic biliary drainage (PTBD) on patients with malignant obstructive jaundice.MethodsThe PubMed, EMbase, The Cochrane Library, CBM, WanFang Data, and CNKI were searched online to collect the randomized controlled trials or cohort studies of EUS-BD versus PTBD on the patients with malignant obstructive jaundice from inception to November 30, 2018. Two reviewers independently screened the literatures, extracted the data and assessed the risk of bias of included the studies, then the meta-analysis was performed by using the RevMan 5.3 software.ResultsThree randomized controlled trials and 6 cohort studies involving 496 patients were included. The results of meta-analysis showed that: compared with the PTBD, the EUS-BD had the lower occurrence of complications [OR=0.30, 95% CI (0.20, 0.47), P<0.000 01], lower rate of reintervention [OR=0.11, 95% CI (0.06, 0.22), P<0.000 01], shorter hospital stay [MD=–3.42, 95% CI (–6.72, –0.13), P=0.04], and less hospital costs [SMD=–0.83, 95% CI (–1.16, –0.49), P<0.000 01]. There were no significant differences in the technical success rate [OR=0.88, 95% CI (0.20, 3.85), P=0.86] and clinical effective rate [OR=1.73, 95% CI (0.97, 3.11), P=0.06] between the two groups.ConclusionsCurrent evidence shows that EUS-BD has some advantages of lower occurrence of complications, lower rate of reintervention, shorter hospital stay, and less hospital costs in treatment of patients with malignant obstructive jaundice as compared with PTBD. There are no significant differences between two groups in technical success rate and clinical effective rate. Due to limited quality and quantity of included studies, more high quality studies required to be verified above conclusions.
ObjectiveTo evaluate the efficacy and safety of traditinal Chinese Medicine (TCM) syndrome classification and intervention for the prophylaxis of menstrual migraine. MethodsPatients consistent with the inclusion criteria from January 2013 to June 2014 were included in the trial. Patients were randomized by their visiting order into two groups:the experimental group was treated with Chinese traditional medicine compound decoctions (two doses for three days), and the control group was treated with vitamin B2 (400 mg once daily). The patients were treated for thirty days consecutively. Efficacy was assessed using the records of the frequency, duration, and severity of migraine attacks. Laboratory tests, vital signs, and adverse events were monitored. ResultsBoth treatments led to a significant reduction in the frequency, duration, and severity of migraine attacks (P<0.05). TCM therapy was significantly better than vitamin B2 for reducing the frequency and the duration of migraine (P<0.05). No serious adverse drug reaction was found in both groups. ConclusionTCM syndrome classification and intervention is effective and relatively safe in the prophylaxis of menstrual migraine attacks.
This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.
Randomized controlled trials (RCTs) are the gold standard for the design of clinical trials. Because of some practical difficulties, more and more researchers think that the appropriate use of non-randomized controlled trials may make up for the weakness of RCT and will achieve the same research purpose. Therefore, non-RCTs are also very important. Taking studies on multiple sclerosis for example, this article briefly introduces the significance of non-randomized contolled trials.
ObjectiveTo investigate the socioeconomic benefits of enhanced recovery after surgery (ERAS) in perioperative period of selective laparoscopic cholecystectomy (LC) by prospective, randomized, controlled clinical study.MethodsA total of 90 patients were recruited in the Hetian Regional People’s Hospital from November 1, 2019 to December 25, 2019. PASS 11 software was used to calculate the sample size. They were grouped into an ERAS group and a tradition group by 1∶1 by random digital table. The patients in the ERAS and the tradition groups were treated with ERAS conception and traditional method respectively during the perioperative period. The postoperative hospitalization time, the first feeding time, the first getting out of bed time, and the first anal exhaust time after operation; the total hospitalization costs, intraoperative infusion, and postoperative total infusion; the intraoperative anesthesia intubation method, trocar layout, and operation time; the pain points of 6 h,12 h and 24 h after operation; the nausea and vomiting after operation; complications and re-hospitalization rate within 30 d after operation were compared between two groups.ResultsA total of 86 patients finally were included in the study, including 44 cases in the ERAS group and 42 cases in the tradition group. The basic data such as the gender, age, body mass index, etiology, blood routine, liver and kidney functions, etc. between the two groups were not statistically significant (P>0.05). Between the two groups, there were no significant differences in the intraoperative anesthesia intubation method, trocar layout, and operation time (P>0.05). Compared with the tradition group, the hospitalization time, the first feeding time, the first getting out of bed time, and the first anal exhaust time after operation were shorter (P<0.05); the total hospitalization costs, intraoperative infusion, and postoperative total infusion were less (P<0.05); the pain points of 6 h,12 h and 24 h after operation were lower (P<0.05); and the times of nausea and vomiting after operation were less (P<0.05) in the ERAS group. There were no complications such as the intraperitoneal bleeding, biliary leakage, and infection after operation, and no re-hospitalized patients within 30 d in both groups.ConclusionApplication of ERAS conception in selective LC perioperative period in Hetian Regional People’s Hospital of Xinjiang Uygur Autonomous Region cannot only shorten postoperative hospitalization time, reduce costs of hospitalization, help to overcome poverty, but also reduce occurrence of complications such as pain, nausea and vomiting, etc.
ObjectiveTo compare the clinical effects of segmentectomy and lobectomy for ≤2 cm lung adenocarcinoma with micropapillary and solid subtype negative by intraoperative frozen sections.MethodsThe patients with adenocarcinoma who received segmentectomy or lobectomy in multicenter from June 2020 to March 2021 were included. They were divided into two groups according to a random number table, including a segmentectomy group (n=119, 44 males and 75 females with an average age of 56.6±8.9 years) and a lobectomy group (n=115, 43 males and 72 females with an average of 56.2±9.5 years). The clinical data of the patients were analyzed.ResultsThere was no significant difference in the baseline data between the two groups (P>0.05). No perioperative death was found. There was no statistical difference in the operation time (111.2±30.0 min vs. 107.3±34.3 min), blood loss (54.2±83.5 mL vs. 40.0±16.4 mL), drainage duration (2.8±0.6 d vs. 2.6±0.6 d), hospital stay time (3.9±2.3 d vs. 3.7±1.1 d) or pathology staging (P>0.05) between the two groups. The postoperative pulmonary function analysis revealed that the mean decreased values of forced vital capacity and forced expiratory volume in one second percent predicted in the segmentectomy group were significantly better than those in the lobectomy group (0.2±0.3 L vs. 0.4±0.3 L, P=0.005; 0.3%±8.1% vs. 2.9%±7.4%, P=0.041).ConclusionSegmentectomy is effective in protecting lungs function, which is expected to improve life quality of patients.
Cardiac surgery presents specific challenges in conducting randomized controlled trials (RCTs). The American Heart Association made a scientific statement of methodological standards, with the purpose to review key concepts and standards in design, implementation, and analysis of cardiac surgery RCTs, and to provide recommendations. Recommendations include an evaluation of the suitability of the research question, clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the effect of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and adequate deliverability of the trial interventions should be ensured. Every effort must be made to keep a high completeness of follow-up. Trial design and analytic techniques must be tailored to the specific research question and trial setting. In this paper, the authors made an interpretation of this scientific statement based on their practical experience.
Objective To assess the effect of naloxone in treating the disease of acute cerebral infarction. Methods Sixty patients of acute cerebral infarction were randomly divided into two groups. One group received routine therapy and the other routine therapy plus naloxone. Neuroprotective effect of naloxone were measured by using NIH stroke scale and Bathel-Index. Adverse effect of the drug was also observed. Results There were 27 patients (90%) improved with clinical manifestations in experiment group, and 20 patients (67%) improved in control group. There is a significant difference between the two groups (Plt;0.05).There is no adverse reactions of naxloxone observed. Conclusion Naloxone might protect the nervous cells and restore the function of the nervous system in patients with acute cerebral infraction.
ObjectivesTo systematically evaluate the efficacy and safety of 1 470 nm laser vaporization vs. transurethral resection of prostate (TURP) for benign prostatic hyperplasia (BPH).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) about the efficacy and safety of 1 470 nm laser vaporization vs. TURP for BPH from inception to October 22nd, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 RCTs and 4 non-RCTs were included. The results of meta-analysis showed that: 1 470 nm laser vaporization was superior to TURP in reducing intraoperative bleeding (MD=−103.87, 95%CI −148.08 to −59.65, P<0.000 01), hospital stay (MD=−3.82, 95%CI −4.35 to −3.28, P<0.000 01), postoperative indwelling catheter time (MD=−2.24, 95%CI −3.45 to −1.02, P=0.000 3), postoperative hemoglobin (MD=−1.63, 95%CI −3.14 to −0.12, P=0.03) and rate of secondary hemorrhage (OR=0.13, 95%CI 0.03 to 0.48, P=0.002). There were no significant differences in operative time, bladder irrigation time, transient urinary incontinence and urethral stricture, IPSS Score and Qmax at 3 months after operation between the two groups (P>0.05).ConclusionCurrent evidence shows that 1 470 nm laser vaporization is superior to TURP in reducing intraoperative bleeding and secondary hemorrhage. It may be more suitable for prostate surgery in anticoagulant or coagulative dysfunction patients. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectivesTo systematically review the efficacy and safety of mechanical thrombectomy for patients with acute ischemic stroke in different ages.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) on the efficacy and safety of mechanical thrombectomy for patients with acute ischemic stroke in different ages from inception to August, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 13 studies involving 2 995 patients were included. The results of meta-analysis showed that compared with the control group, patients aged 80 and above had no statistically significant difference in reperfusion success rates (OR=0.90, 95%CI 0.71 to 1.14, P=0.378), and incidence of symptomatic intracranial hemorrhage (OR=1.30, 95%CI 0.86 to 1.94, P=0.212), however, with higher incidence of arbitrary intracranial bleeding events (OR=1.61, 95%CI 1.28 to 2.04, P<0.001), 3-month mortality (OR=2.14, 95%CI 1.73 to 2.64, P<0.001) and lower good functional prognosis rate at 3 months (OR=0.46, 95%CI 0.30 to 0.71, P<0.001).ConclusionsCurrent evidence suggests that people aged 80 and above can obtain effective perfusion through mechanical thrombectomy, however, the incidence of postoperative adverse outcome events is higher and the prognosis is relatively poor. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.