ObjectiveTo evaluate the effect of driving pressure-guided lung protective ventilation strategy on lung function in adult patients under elective cardiac surgery with cardiopulmonary bypass.MethodsIn this randomized controlled trial, 106 patients scheduled for elective valve surgery via median sternal incision under cardiopulmonary bypass from July to October 2020 at West China Hospital of Sichuan University were included in final analysis. Patients were divided into two groups randomly. Both groups received volume-controlled ventilation. A protective ventilation group (a control group, n=53) underwent traditional lung protective ventilation strategy with positive end-expiratory pressure (PEEP) of 5 cm H2O and received conventional protective ventilation with tidal volume of 7 mL/kg of predicted body weight and PEEP of 5 cm H2O, and recruitment maneuver. An individualized PEEP group (a driving pressure group, n=53) received the same tidal volume and recruitment, but with individualized PEEP which produced the lowest driving pressure. The primary outcome was oxygen index (OI) after ICU admission in 30 minutes, and the secondary outcomes were the incidence of OI below 300 mm Hg, the severity of OI descending scale (the Berlin definition), the incidence of pulmonary complications at 7 days after surgery and surgeons’ satisfaction on ventilation.ResultsThere was a statistical difference in OI after ICU admission in 30 minutes between the two groups (273.5±75.5 mm Hg vs. 358.0±65.3 mm Hg, P=0.00). The driving pressure group had lower incidence of postoperative OI<300 mm Hg (16.9% vs. 49.0%, OR=0.21, 95%CI 0.08-0.52, P=0.00) and less severity of OI classification than the control group (P=0.00). The incidence of pulmonary complications at 7 days after surgery was comparable between the driving pressure group and the control group (28.3% vs. 33.9%, OR=0.76, 95%CI 0.33-1.75, P=0.48). The atelectasis rate was lower in the driving pressure group (1.0% vs. 15.0%, OR=0.10, 95%CI 0.01-0.89, P=0.01).ConclusionApplication of driving pressure-guided ventilation is associated with a higher OI and less lung injury after ICU admission compared with the conventional protective ventilation in patients having valve surgery.
ObjectiveTo probe into the clinical value of supine cervical vertebra traction with neck flexion in treating cervical spondylotic radiculopathy. MethodsFrom August 2011 to December 2013, 71 patients were divided randomly into a treatment group of 36 cases and a control group of 35 cases. They were treated respectively with supine cervical vertebra traction with neck flexion, and cervical vertebra traction on a sitting position. Both groups had acupuncture, moxibustion, massage and medium frequency electrotherapy. The period of observation was 15 days. We evaluated the results by surveying physiological curvature of the cervical spine on lateral radiograph, and visual analogue scale (VAS), neck disability index (NDI), criteria of diagnosis and therapeutic effect of syndromes in traditional Chinese medicine syndrome and clinical assessment scale for cervical spondylosis (CASCS) were also used. ResultsPhysiological curvature of cervical spine was much improved in both groups after treatment (P<0.05). The distance of cervical vertebra arc between vertebral anterior edge sequences in treatment group before treating was (4.07±3.63) mm and it was (9.03±4.31) mm after treatment. For the control group, those two numbers were respectively (4.13±3.02) and (8.87±3.97) mm. There was no significant difference in the distance of cervical vertebra arc and its increase between vertebral anterior edge between the two groups after treatment. There was significant difference in the efficiency rate between the two groups (P<0.05) (treatment group 100.00%, control group 97.14%). When cured rate and cured-markedly effective rate were added, the treatment group (80.56%) was much better than the control group (51.43%) (P<0.01). As to VAS score, NDI and CASCS scores, both groups got much better after treatment (P<0.01). For VAS, the treatment group decreased from 8.43±0.75 before treatment to 1.40±0.61 after treatment, while the control group from 8.35±0.78 before treatment to 2.55±0.59 after treatment. For NDI, the treatment group decreased from 54.13±7.44 before treatment to 10.78±4.55 after treatment, while the control group from 55.85±8.72 to 12.66±5.48. For CASCS, the treatment group rose from 34.88±5.39 before treatment to 74.65±6.73 after treatment, while the control group from 34.77±4.89 to 69.03±6.21. After treatment, VAS score of the treatment group was much lower than the control group (P<0.01). There was no difference between the two groups on NDI (P>0.05). CASCS score of the treatment group was significantly higher than the control group after the treatment (P<0.01). There was no significant difference in the increase of CASCS score between the two groups after treatment (P>0.05). ConclusionVertebra traction combined with acupuncture, moxibustion, massage and medium frequency electrotherapy is therapeutic for cervical spondylotic radiculopathy and traction at a supine and flexing position is better.
ObjectiveTo evaluate the impact of local infiltration analgesia on postoperative pain after hip arthroplasty. MethodsRelevant randomized controlled trials comparing the analgesia effect and adverse effects between local infiltration analgesia group and non-local infiltration analgesia group (control group) were identified from Cochrane Library, Embase, PubMed, China National Knowledge Infrastructure, VIP database and Wanfang database from their establishment until May 2016. A systematic review was performed to compare the pain scores and adverse events between those two groups. Effective data were pooled for Meta-analysis with software RevMan 5.2.0. ResultsTwelve eligible trials were identified in this study. The pain scores of the two groups of patients during rest time after surgery were significantly different[WMD=-19.06, 95%CI (-21.51, -16.62), P<0.000 01]; the pain scores were also significantly different during activity time[WMD=-11.45, 95%CI (-15.56, -7.34), P<0.000 01]. There was significant difference in postoperative nausea and vomiting between the two groups[RR=0.59, 95%CI (0.42, 0.84), P=0.003]. The pain degree and incidence of nausea and vomiting in the local infiltration analgesia group were lower than the control group, but there was no significant difference between the two groups in terms of urinary retention, itch and hypotension (P>0.05). ConclusionLocal infiltration analgesia is effective in reducing postoperative pain without any additional adverse reactions.
Objective To investigate the effect of different degrees of wound eversion on scar formation at the donor site of anterolateral thigh flaps by a prospective clinical randomized controlled study. MethodsAccording to the degree of wound eversion, the clinical trial was designed with groups of non-eversion (group A), eversion of 0.5 cm (group B), and eversion of 1.0 cm (group C). Patients who underwent anterolateral femoral flap transplantation between September 2021 and March 2023 were collected as study subjects, and a total of 36 patients were included according to the selection criteria. After resected the anterolateral thigh flaps during operation, the wound at donor site of each patient was divided into two equal incisions, and the random number table method was used to group them (n=24) and perform corresponding treatments. Thirty of these patients completed follow-up and were included in the final study (group A n=18, group B n=23, and group C n=29). There were 26 males and 4 females with a median age of 53 years (range, 35-62 years). The body mass index was 17.88-29.18 kg/m2 (mean, 23.09 kg/m2). There was no significant difference in the age and body mass index between groups (P>0.05). The incision healing and scar quality of three groups were compared, as well as the Patient and Observer Scar Assessment Scale (POSAS) score [including the observer component of the POSAS (OSAS) and the patient component of the POSAS (PSAS)], Vancouver Scar Scale (VSS) score, scar width, and patient satisfaction score [visual analogue scale (VAS) score]. Results In group C, 1 case had poor healing of the incision after operation, which healed after debridement and dressing change; 1 case had incision necrosis at 3 months after operation, which healed by second intention after active dressing change and suturing again. The other incisions in all groups healed by first intention. At 6 months after operation, the PSAS, OSAS, and patient satisfaction scores were the lowest in group B, followed by group A, and the highest in group C. The differences between the groups were significant (P<0.05). There was no significant difference between the groups in the VSS scores and scar widths (P>0.05). ConclusionModerate everted closure may reduce the formation of hypertrophic scars at the incision site of the anterior lateral thigh flap to a certain extent.
ObjectiveTo compare the knee flexion degree after high-flexion versus standard total knee arthroplasty (TKA). MethodRelevant randomized controlled trials on comparison of knee flexion degree after high-flexion versus standard TKA were identified from Cochrane Library, PubMed, Embase, China National Knowledge Infrastructure from the establishment of these databases until October 2015. A systematic review was performed to compare knee flexion degree, knee function score and complications between the two types of prostheses. Analyses were conducted using RevMan version 5.2.0 software. ResultsTwenty-one studies were included in this Meta-analysis. The results showed that the knee flexion degree was higher in high-flexion group than that in the standard group[WMD=2.71°, 95%CI (0.96, 4.46)°, P=0.002]; while the difference was not significant leaving out six low-quality literatures[WMD=0.72°, 95%CI (-0.15, 1.60)°, P=0.10]. There was no significant difference in knee function score between the two groups[WMD=-0.54, 95%CI (-1.34, 0.25), P=0.18]. There was no significant difference in complications between the two groups[OR=0.99, 95%CI (0.53, 1.84), P=0.98]. ConclusionsThe important finding from the current study is that there is no evidence to support that the use of high-flexion prostheses is superior to the standard prostheses during total knee arthroplasty.
Objective To compare the efficacy of incision healing by abdominal wall closure measure without suturing subcutaneous fat layer and the traditional abdominal wall closure measure. Methods Four hundreds patients underwent operation of abdominal median incision and abdominal paramedian incision from Sep. 2010 to Sep. 2012 in our department were randomly assigned to observation group （n=199） and control group （n=201）. The patients in obser- vation group underwent abdominal wall closure measure without suturing subcutaneous fat layer， and those of control group were subjected to abdominal wall closure by traditional layer suture technique. Comparison of efficacy of incision healing in the 2 groups was performed. Results The incidences of fat liquefication 〔1 （0.5%） vs.18 （9.0%）〕， incision swelling 〔3 （1.5%） vs.16 （8.0%）〕， incision induration 〔1 （0.5%） vs.15 （7.5%）〕， and dehiscence of wound 〔0 （0） vs.9 （4.5%）〕 in observation group were significantly lower than those of control group （P＜0.01）， but there was no significant difference in incidence of subcutaneous hematoma 〔2 （1.0%） vs.0 （0）， P＞0.05〕. The rate of primary healing in obser-vation group was significantly higher than those of control group 〔199 （100%） vs.186 （92.5%）， P＜0.01〕. Duration of abdominal closure 〔（13.0±1.6） min vs.（18.0±2.2） min〕 and postoperative hospital stay 〔（7.7±1.3） days vs.（9.6±1.9） days〕 were all shorter than those of control group （P＜0.01）. Conclusion The abdominal wall closure measure without suturing subcutaneous fat layer is obviously more effective to the traditional layer suture technique， which is a suture way worthy to spread.
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 investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. MethodsA study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference (P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. Results ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups (P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant (P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant (P>0.05). There was no significant difference in the operation time between groups (P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups (P<0.05); there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant (P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups (P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups (P>0.05), while there was a significant difference in IL-6 between groups (P<0.05). Conclusion Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.