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PurposeIncreased levels of uric acid (UA), which is mainly excreted through the kidneys, are independently associated with higher mortality in end-stage renal disease (ESRD) patients. The uricolysis of gut microbiota plays an important role in extrarenal excretion of UA. This study aimed to examine the effect of inulin-type prebiotics (a type of fermentable dietary fiber) on intestinal microbiota modulation and serum UA levels in ESRD patients.MethodsContinuous ambulatory peritoneal dialysis (CAPD) patients were recruited to a randomized, double-blind, placebo-controlled crossover trial of 12-week inulin-type prebiotics. Participants were visited before and after treatment with prebiotics or placebo. Serum UA levels, dietary purine intake, serum xanthine oxidase (XO) activity, daily “renal excretion” of UA, and fecal UA degradation capability were measured at each visit. Fecal metagenomic analysis was conducted to assess microbial composition and function.ResultsSixteen participants (mean age = 37 y; 10 men and 6 women) completed the trial, and 64 specimens were analyzed. The average concentration of serum UA decreased by approximately 10% in the prebiotic intervention group in comparison to the placebo group (p = 0.047) without an increase in daily “renal excretion” of UA via urine and dialysate. There were no significant changes in purine intake or activity of XO. Notably, enhanced fecal UA degradation was observed after prebiotic intervention (p = 0.041), and the ratio of Firmicutes/Bacteroidetes, which was positively associated with fecal UA degradation, increased in the prebiotic period (p = 0.032). Furthermore, prebiotics enriched purine-degrading species in the gut microbiota, including unclassified_o_Clostridiales, Clostridium sp. CAG:7, Clostridium sp. FS41, Clostridium citroniae, Anaerostipes caccae, and Clostridium botulinum.ConclusionsInulin-type prebiotics is a promising therapeutic candidate to reduce serum UA levels in renal failure patients, and this urate-lowering effect could possibly be attributed to intestinal microbial degradation of UA.Trial registryThis study was registered at the Chinese Clinical Trials Registry (http://www.chictr.org.cn/), registration ID: ChiCTR-INR-17013739, registration date: 6th Dec 2017.

BackgroundIrritable bowel syndrome (IBS) is a heterogeneous disease, which is closely related to environmental factors and gut microbiota.ObjectiveTo study gut microbiota in IBS-D of Han nationality in Southwest China and explore its relationship with environmental factors.MethodsOne hundred and twenty cases of IBS-D and 63 cases of HCs were recruited; baseline data such as age, height, and weight were collected. HAMA, HAMD, IBS-SSS, IBS-QOL, and laboratory tests were performed. Feces were collected for 16S rDNA sequencing. Then, the differences of gut microbiota were analyzed and looked for biomarkers of each. FAPROTAX was used to predict the functional differences of gut microbiota. Spearman analysis was conducted between the phylum level and environmental factor.ResultsThere were significant differences in daily life between IBS-D and HCs, especially in the spicy taste. The scores of HAMA and HAMD, urea, and transaminase in IBS-D were significantly higher than those of HCs. The richness of gut microbiota in IBS-D was significantly lower than that of HCs, as well as the beta diversity, but not diversity. The biomarkers of IBS-D were Prevotella, Clostridiales, and Roseburia, and the biomarkers of HCs were Veillonellaceae, Bacteroides coprocola, and Bifidobacteriales. The functions of gut microbiota in IBS-D were significantly different from HCs. Correlation analysis showed that multiple gut microbiota were closely related to HAMA, IBS-SSS, IBS-QOL, inflammatory indexes, and liver enzymes.ConclusionThere are significant differences in richness of gut microbiota, flora structure, and flora function between IBS-D and HCs in Southwest China. These differences may be closely related to environmental factors such as eating habits, living habits, and mental and psychological factors.Clinical Trial RegistrationThe trial was registered and approved in China Clinical Trial Registry (Registration No. ChiCTR2100045751).

Objective The aim of this study was to examine the effects of progressive upper limb exercises and muscle relaxation training (PULE-MRT) on upper limb function and health-related quality of life (HRQoL) following surgery in Chinese mainland women with breast cancer (BC). Methods Overall, 102 patients following surgery (i.e. mastectomy or breast-conserving surgery, with sentinel lymph node biopsy or axillary lymph node dissection) were randomly allocated to the intervention ( n  = 51) or control ( n  = 51) groups. The former received PULE-MRT plus routine nursing care, whereas the latter received only routine nursing care for 6 months. Upper limb function and HRQoL were measured at baseline and 1, 3, and 6 months using Constant–Murley scores (CMS) and Functional Assessment of Cancer Therapy-Breast version 4.0 (FACT-Bv4.0), respectively. Results All patients in the intervention group completed the exercises and training, with 100% compliance and no adverse events. The intervention group had significantly higher total CMS and FACT-Bv4.0 scores at 1-, 3-, and 6-month follow-up than the control group. The significant effects in total CMS comparisons were group ( F  = 25.30, p  < 0.001), time ( F  = 18.02, p  < 0.001), and group-by-time interaction ( F  = 9.95, p  < 0.001), and, in FACT-Bv4.0, total score comparisons were group ( F  = 15.87, p  < 0.001), time ( F  = 17.92, p  < 0.001), and group-by-time interaction ( F  = 7.88, p  < 0.001). Similar results were observed for the scale scores of CMS and FACT-Bv4.0. Conclusions PULE-MRT had positive effects on improving upper limb function and HRQoL following surgery in women with BC and could be used as an optional rehabilitation management strategy in post-surgery BC patient populations. Trial Registration ChiCTR-IOR-16008253 (Chictr.org.cn; 9 April 2016).

PurposeBoth erector spinae plane block and wound infiltration are used to improve analgesia following spinal fusion surgery. Herein, we compared the analgesic effect of bilateral erector spinae plane block with wound infiltration in this patient population.MethodsIn this randomized trial, 60 patients scheduled for elective open posterior lumbar interbody fusion surgery were randomized to receive either ultrasound-guided bilateral erector spinae plane block before incision (n = 30) or wound infiltration at the end of surgery (n = 30). Both groups received standardized general anesthesia and postoperative analgesia, including patient-controlled analgesia with sufentanil and no background infusion. Opioid consumption and pain intensity were assessed at 2, 6, 12, 24, and 48 h after surgery. The primary outcome was cumulative opioid consumption within 24 h after surgery.ResultsAll 60 patients were included in the intention-to-treat analysis. The equivalent dose of sufentanil consumption within 24 h was significantly lower in patients given erector spinae plane block (median 11 μg, interquartile range 5–16) than in those given wound infiltration (20 μg, 10 to 43; median difference − 10 μg, 95% CI − 18 to − 3, P = 0.007). The cumulative number of demanded PCA boluses was significantly lower with erector spinae plane block at 6 h (median difference − 2, 95% CI − 3 to 0, P = 0.006), 12 h (− 3, 95% CI − 6 to − 1, P = 0.002), and 24 h (− 5, 95% CI − 8 to − 2, P = 0.005) postoperatively. The proportion given rescue analgesia was also significantly lower in patients given erector spinae plane block group within 48 h (relative risk 0.27, 95% CI 0.07 to 0.96, P = 0.037). There were no statistical differences in pain intensity at any timepoints between groups. No procedure-related adverse events occurred.ConclusionsCompared with wound infiltration, bilateral ultrasound-guided erector spinae plane block decreases short-term opioid consumption while providing similar analgesia in patients following lumbar spinal fusion surgery.Chinese Clinical Trial Registry: ChiCTR2100053008.

BackgroundThere have been no prospective randomized controlled clinical trials evaluating the advantages of the magnetic anchor technique (MAT) used in reduced-port laparoscopic cholecystectomy (LC). The present study evaluated a novel magnetic anchor device designed by the authors.MethodsBetween April 2019 and June 2020, 60 patients with gallbladder diseases participated in a single-center, prospective, randomized controlled clinical trial. The patients were randomly apportioned to undergo either 2-port LC assisted by the novel MAT (MAT-2P-LC, experimental group) or conventional 3-port LC (3P-LC, control). The groups were compared regarding operative time, postoperative complications, surgical incision pain score (Wong–Baker), and other indicators. The patients were followed for 2 years.ResultsThe test and control groups were comparable in age, gender, body mass index, and primary disease. No patient in the MAT-2P-LC group was converted to 3P-LC. No patients were converted to laparotomy. On the first postoperative day, the Wong–Baker pain score of the experimental group (1.60 ± 0.67) was significantly lower than that of the control (2.20 ± 0.76; P = 0.002). The groups were statistically similar regarding intraoperative blood loss; operative time; time to leave bed; hospital stay; postoperative pain scores at 1 and 4 weeks; and complications.ConclusionsThis rigorous clinical trial shows that the novel MAT used to assist reduced-port LC significantly reduced postoperative pain, but has no obvious advantages in other terms. Clinical Trails.gov. number, ChiCTR1800019464.

IntroductionA novel neurosurgical enhanced recovery after surgery (ERAS) program shortens postoperative hospital stay and accelerates functional recovery in elective craniotomy patients. There is a need to evaluate the impact of ERAS program on patients’ health-related quality of life (HRQOL).MethodsIn a single-center randomized controlled trial, patients were randomized 1:1 to receive perioperative ERAS or conventional care. As a secondary outcome, HRQOL was measured with the EORTC QLQ-C30/BN20 prior to randomization (baseline), at discharge, and at 3- and 6-month follow-up.ResultsA total of 65 patients (ERAS: n = 36, conventional care: n = 29) with pathologically confirmed glioma (WHO grade 2–4) were included in the analysis. Progression-free survival at 6 months and HRQOL at baseline were similar between the two groups. Changes of scores did not vary significantly over time, but differed significantly between intervention groups. A clinically relevant better QoL (at 3-month follow-up), physical functioning (at 6-month follow-up) and role functioning (at discharge) was observed in patients in the ERAS group. Symptom scores of constipation (at discharge), motor dysfunction (at discharge, 3- and 6-month follow-up), drowsiness (at 3- and 6-month follow-up), weakness of legs (at 3-month follow-up), and nausea/vomiting (at discharge and 6-month follow-up) were significantly lower in the ERAS group.ConclusionsThe neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care. The intervention has a significant main effect HRQOL changes without significant interaction with time. Future well-powered multicenter studies are warranted to confirm this result and address long-term benefits.This study has been registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=16480) with registration number ChiCTR-INR-16009662.

Purpose To establish the optimal dose of indocyanine green (ICG) to administer intravenously 30 min before laparoscopic cholecystectomy (LC). Methods In this randomized controlled trial (RCT), patients undergoing LC for cholecystitis, cholelithiasis, and/or cholecystic polyps were randomized into four groups given four different ICG doses (0.025, 0.1, 0.25, 2.5 mg). Using OptoMedic endoscopy combined with a near-infrared fluorescent imaging system, we evaluated the fluorescence intensity (FI) of the common bile duct and liver at three timepoints: before surgical dissection of the cystohepatic triangle, before clipping of the cystic duct, and before closure. The bile duct-to-liver ratio (BLR) of the FI was analyzed to assess the cholangiography effect. Results Sixty-four patients were allocated to one of four groups, with 40 patients included in the final analysis. Generally, with increasing ICG doses, the levels of FI in the bile duct and liver increased gradually at each of the three timepoints. Before surgical dissection of the cystohepatic triangle, 0.1-mg ICG showed the highest BLR ( F  = 3.47, p  = 0.0259). Before clipping the cystic duct and before closure, the 0.025- and 0.1-mg groups showed a higher BLR than the 0.25- and 2.5-mg groups ( p  < 0.05). When setting the ideal cholangiography at a BLR ≥ 1, ≥ 3, or ≥ 5, the 0.1-mg group showed the highest qualified case number at the three timepoints. Conclusions The intravenous administration of 0.1-mg ICG, 30 min before LC, is significantly better for fluorescent cholangiography of the extrahepatic biliary structures before dissection and clipping of the cystohepatic triangle. Trial registration This study was registered in the Chinese Clinical Trial Registry (ChiCTR) (ChiCTR2200057933).

BackgroundWith the development of surgical technics, endoscopic thyroid surgery has been gradually accepted and utilized in thyroid disease treatment, including thyroid carcinoma. This study aimed to evaluate the learning curve for endoscopic hemithyroidectomy (EHT) with ipsilateral central neck dissection (CND) and investigate how many cases must be performed before a surgeon becomes competent and proficient in this approach.MethodsNinety-nine consecutive patients who underwent EHT with ipsilateral CND for papillary thyroid microcarcinoma by a single surgeon between June 2015 and October 2017 were analyzed. Multidimensional cumulative summation (CUSUM) analysis was performed to evaluate the learning curve.ResultsThe CUSUM graph showed the learning curve ascended in the first 31 cases and declined in the following cases. The number of lymph nodes removed in phase 2 (the following 68 cases) was significantly more than that in phase 1 (the first 31 cases) (5.06 ± 1.44 vs. 4.19 ± 1.51, P = 0.001). The operation time in phase 2 was shorter than that in phase 1 (123.38 ± 12.71 min vs. 132.90 ± 13.95 min, P = 0.008) and the rate of accidental removal of parathyroid gland decreased from 35.5% in phase 1 to 16.2% in phase 2 (P = 0.040). There was a declining trend but no significant difference in the rate of postoperative complications (9.7% in phase 2 vs. 4.4% in phase 1, P = 0.309).ConclusionEHT with ipsilateral CND performed by surgeons was mastered after 31 cases, and the safety and feasibility of this endoscopic approach can also be demonstrated.

Plasma epidermal growth factor receptor mutation (EGFRm) circulating tumor DNA (ctDNA) dynamics exhibit promise in predicting outcomes in patients with EGFRm-advanced non-small cell lung cancer (NSCLC). However, there remains limited trial-level data on integrating ctDNA monitoring into clinical practice. We performed a prospective, multicenter trial to investigate the relationship between EGFRm ctDNA dynamic changes and clinical outcomes in NSCLC patients with EGFRm. Ninety-eight treatment-naive EGFRm-advanced NSCLC patients were recruited and administered icotinib until disease progression. Plasma samples were collected at baseline and four weeks after icotinib administration. ctDNA was analyzed using a droplet-digital polymerase chain reaction. At baseline, 71.4% of patients had detectable EGFRm ctDNA. Among them, 45.9% of patients’ ctDNA became undetectable within four weeks of treatment. These patients demonstrated significantly longer progression-free survival (PFS) and overall survival (OS) than those with detectable ctDNA after treatment ( P  = 0.004 and < 0.001, respectively) and were comparable to those with undetectable ctDNA at both baseline and four weeks. ctDNA detectable at four weeks emerged as a poor independent risk factor for PFS and OS. Patients whose ctDNA became undetectable after treatment had outcomes similar to those with initially undetectable ctDNA, underscoring the predictive value of ctDNA dynamics in treatment efficacy. Registry and the Registration No. of the study/trial: ChiCTR-DDD-17013131. Date of registration: 2017-10-27.

Purpose To explore the safety and role of tegafur/gimeracil/oteracil (S1) maintenance therapy (MT) in metastatic nasopharyngeal carcinoma (NPC) patients after response to first-line chemotherapy and to assess outcome-associated biomarkers. Methods This was a multicentre, open-label, randomized controlled study involving metastatic NPC patients recruited (from May 2015 to May 2019) at five hospitals in China. The participants were randomized to S1-MT (receiving S1 MT until disease progression or intolerance) or non-MT (followed up until disease progression) groups. The primary endpoint was the progression-free survival (PFS). The secondary endpoints were the overall survival (OS), the correlation between EBV-DNA, serum amyloid A (SAA) status, and outcomes after the first-line chemotherapy, and safety. Results The median follow-up was 24.3 months; 88 and 95 participants were evaluable in the S1-MT and non-MT groups, respectively. Compared with non-MT, S1-MT prolonged PFS (16.9 vs. 9.3 months, P  < 0.001) and OS (33.6 vs. 20.6 months, P  < 0.001). Regardless of their EBV-DNA status after first-line chemotherapy, participants were able to benefit from S1 MT, but EBV-DNA-positive participants benefited more significantly (PFS: HR = 0.600, 95% CI = 0.373–0.965, P  = 0.035; OS: HR = 0.393, 95% CI = 0.227–0.681, P  = 0.001). MT only improved PFS and OS in patients with an SAA decline after first-line chemotherapy (PFS: HR = 0.570, 95% CI = 0.350–0.919, P  = 0.021; OS: HR = 0.404, 95% CI = 0.230–0.709, P  = 0.002). The median S1 treatment was 23 cycles. Grade 1–2 skin pigmentation, oral mucositis, and hand and foot syndrome were the main adverse reactions. Conclusion For metastatic NPC patients with first-line chemotherapy response, S1 MT can improve PFS and OS, with good tolerability. EBV-DNA and SAA can better help us identify patients who can benefit from MT after standard treatment. Trial registration The study protocol was registered at the Chinese Clinical Trial Registry (ChiCTR-IOR-16007939).