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find Keyword "randomized controlled study" 7 results
  • Efficacy and safety of different methods of lymphadenectomy for early stage non-small-cell lung cancer: a meta-analysis

    Objectives To systematically review the efficacy and safety of non-systemic lymph dissection (NSMLD) vs. systemic lymph dissection (SMLD) for early stage non-small cell lung cancer (NSCLC). Methods PubMed, EMbase, Web of Science and The Cochrane Library databases were searched online to collect randomized controlled trials (RCTs) and non-randomized controlled studies (NRCTs) of NSMLD vs. SMLD for NSCLC patients from inception to October, 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 16 studies (4 RCTs and 12 NRCTs) involving 4 718 patients were included. The results of meta-analysis showed that: Compared with the SMLD group, the NSMLD group had higher mortality (HR=1.23, 95%CI 1.11 to 1.37, P<0.000 1). There were no significant differences in disease-free survival, local recurrence rate, distant metastasis rate, and safety between two groups. In addition, the NSMLD group had shorter operation time, and lower drainage and blood loss. Subgroup analysis was performed according to operation methods. The results showed that: NSMLD group by lymph node sampling (LN-S) had higher mortality than SMLD group (HR=1.43, 95%CI 1.17 to 1.75,P=0.004), NSMLD group by lobe-specific lymph node dissection (L-SLD) did not have higher mortality. Conclusions Current evidence shows that: compared with SMLD, NSMLD by L-SLD do not have higher mortality in early stage NSCLC patients, while NSMLD by LN-S have higher mortality. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.

    Release date:2018-01-20 10:09 Export PDF Favorites Scan
  • A prospective randomized controlled study of total knee arthroplasty via mini-subvastus and conventional approach

    ObjectiveTo compare the clinical and radiographic results between primary total knee arthroplasty (TKA) via mini-subvastus or conventional approach through a prospective randomized controlled study.MethodsNinety-four patients (104 knees) undergoing primary TKA between January 2011 and April 2012 were evaluated and randomly divided into 2 groups. Forty-six patients (52 knees) underwent TKA via conventional approach (conventional approach group), and 48 patients (52 knees) underwent TKA via mini-subvastus approach (mini-subvastus approach group). In these patients, 45 cases (51 knees) in conventional approach group and 45 cases (49 knees) in mini-subvastus approach group were followed up and recruited in the final analysis. There was no significant difference in age, gender, body mass index, sides, osteoarthritis grading, American Knee Society Score (KSS), Hospital for Special Surgery (HSS) score, visual analogue scale (VAS), range of motion (ROM) of knee between 2 groups (P>0.05). The clinical indexes were recorded and analyzed, including the operation time, length of incision, total blood loss, blood transfusion after operation, hospital stay time, the time of performing straight leg raise, incision condition, VAS score, ROM of knee, HSS score, and KSS score, hip-knee-ankle angle (HKA), femoral anatomic axis and the femoral prosthesis joint angle (femoral angle), tibia anatomic axis and tibial prosthesis joint angle (tibial angle), femoral prosthesis flexion angle (FPFA), and posterior slope angle (PSA) of the tibial plateau.ResultsAll patients were followed up. The average follow-up time was 66.4 months (range, 60.0-72.5 months) in conventional approach group and 65.6 months (range, 60.0-71.2 months) in mini-subvastus approach group. Compared with the conventional approach group, the incision of mini-subvastus approach group shortened, the operation time prolonged, and the time when patients started straight leg raise exercises was earlier; showing significant differences between 2 groups (P<0.05). There was no significant difference in hospital stay time, total blood loss, and numbers of blood transfusion between 2 groups (P>0.05). The complication rate was 8.2% (4/49) in mini-subvastus approach group and 0 in conventional approach group, showing no significant difference between 2 groups (P=0.054). At 1 and 3 days, the VAS and the ROM of knee in mini-subvastus approach group were significantly better than those in conventional approach group (P<0.05); but there was no significant difference in above indexes between 2 groups at 14 day (P>0.05). There was no significant difference in HSS and KSS scores between 2 groups at the 1, 3, 6, 12 months and 3, 5 years (P>0.05). X-ray film showed no aseptic loosening in all cases. There was no significant difference in the measured values and incidence of abnormal patient of HKA, femoral angle, tibial angle, FPFA, and PSA at last follow-up between 2 groups (P>0.05).ConclusionTKA via mini-subvastus approach is helpful to the early function recovery of knee, but the long-term effectiveness is consistent with TKA via conventional approach. As the limited exposure, TKA via mini-subvastus spproach may has high risk of operative complications.

    Release date:2018-02-07 03:21 Export PDF Favorites Scan
  • Effect of driving pressure-guided lung protective ventilation strategy on early postoperative pulmonary function in adults patients undergoing heart valve surgery: A randomized controlled study

    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.

    Release date:2021-07-02 05:22 Export PDF Favorites Scan
  • Thoracic drainage with traditional chest tube versus central venous catheter after video-assisted thoracoscopic lobectomy: A randomized controlled study

    ObjectiveTo evaluate the effectiveness and safety of a central venous catheter for thoracic drainage after video-assisted thoracoscopic lobectomy compared with a conventional chest tube.MethodsThis study collected 200 patients with lung cancer who underwent thoracoscopic lobectomy and systematic hilar and mediastinal lymph node dissection between January 2018 and September 2019 in our hospital. The patients were randomly divided into two groups, including a group A (left with 28F chest tubes postoperatively) and a group B (left with 12G central venous catheters postoperatively). Patients in both groups were left with 2 chest tubes after upper lobectomy and 1 chest tube after middle or lower lobectomy. Duration and total volume of drainage, length of hospital stay, maximum visual analogue scale score and so forth were compared between the two groups.ResultsFinally, 151 patients were included for analysis. There were 73 patients in the group A, including 26 males and 47 females, with an average age of 55.38±9.95 years, and 78 patients in the group B, including 37 males and 41 females, with an average age of 59.86±10.18 years. No statistical difference was found between the two groups in drainage volume on postoperative day 2, and proportion of prolonged air leaks, hemothorax, chylothorax or drain reinsertion (all P>0.05). There was a statistical difference in drainage volume on postoperative day 1 [200.0 (120.0, 280.0) mL vs. 57.5 (10.0, 157.5) mL, P=0.000], postoperative day 3 [155.0 (100.0, 210.0) mL vs. 150.0 (80.0, 215.0) mL, P=0.023], total volume of drainage [890.0 (597.5, 1 530.0) mL vs. 512.5 (302.5, 786.3) mL,P=0.000], maximum pain score (2.29±0.72 points vs. 2.09±0.51 points, P=0.013) and length of hospital stay [7 (7, 9) d vs. 5 (4, 7) d, P=0.000].ConclusionCompared with conventional chest tubes, central venous catheters for chest drainage in patients with lung cancer after thoracoscopic lobectomy shortens the length of hospital stay and reduces postoperative pain.

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  • Effectiveness of preemptive analgesia with imrecoxib on analgesia after anterior cruciate ligament reconstruction: a randomized controlled study

    ObjectiveTo investigate the effectiveness of preemptive analgesia with imrecoxib on analgesia after anterior cruciate ligament (ACL) reconstruction. MethodsA total of 160 patients with ACL injuries who met the selection criteria and were admitted between November 2020 and August 2021 were selected and divided into 4 groups according to the random number table method (n=40). Group A began to take imrecoxib 3 days before operation (100 mg/time, 2 times/day); group B began to take imrecoxib 1 day before operation (100 mg/time, 2 times/day); group C took 200 mg of imrecoxib 2 hours before operation (5 mL of water); and group D did not take any analgesic drugs before operation. There was no significant difference in gender, age, body mass index, constituent ratio of meniscal injuries with preoperative MRI grade 3, constituent ratio of cartilage injury Outerbridge grade 3, and visual analogue scale (VAS) score at the time of injury and at rest among 4 groups (P>0.05). The operation time, hospitalization stay, constituent ratio of perioperative American Society of Anesthesiologists (ASA) grade 1, postoperative opioid dosage, and complications were recorded. The VAS scores were used to evaluate the degree of knee joint pain, including resting VAS scores before operation and at 6, 24, 48 hours, and 1, 3, 6, and 12 months after operation, and walking, knee flexion, and night VAS scores at 1, 3, 6, and 12 months after operation. The knee injury and osteoarthritis score (KOOS) was used to evaluate postoperative quality of life and knee-related symptoms of patients, mainly including pain, symptoms, daily activities, sports and entertainment functions, knee-related quality of life (QOL); and the Lysholm score was used to evaluate knee joint function. ResultsAll patients were followed up 1 year. There was no significant difference in operation time, hospitalization time, or constituent ratio of perioperative ASA grade 1 among 4 groups (P>0.05); the dosage of opioids in groups A-C was significantly less than that in group D (P<0.05). Except for 1 case of postoperative fever in group B, no complications such as joint infection, deep vein thrombosis of the lower extremities, or knee joint instability occurred in each group. The resting VAS scores of groups A-C at 6 and 24 hours after operation were lower than those of group D, and the score of group A at 6 hours after operation was lower than those of group C, and the differences were significant (P<0.05). At 1 month after operation, the knee flexion VAS scores of groups A-C were lower than those of group D, the walking VAS scores of groups A and B were lower than those of groups C and D, the differences were significant (P<0.05). At 1 month after operation, the KOOS pain scores in groups A-C were higher than those in group D, there was significant difference between groups A, B and group D (P<0.05); the KOOS QOL scores in groups A-C were higher than that in group D, all showing significant differences (P<0.05), but there was no significant difference between groups A-C (P>0.05). There was no significant difference in VAS scores and KOOS scores between the groups at other time points (P>0.05). And there was no significant difference in Lysholm scores between the groups at 1, 3, 6, and 12 months after operation (P>0.05). ConclusionCompared with the traditional analgesic scheme, applying the concept of preemptive analgesia with imrecoxib to manage the perioperative pain of ACL reconstruction can effectively reduce the early postoperative pain, reduce the dosage of opioids, and promote the early recovery of limb function.

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  • Clinical efficacy of total thoracoscopic mitral valvuloplasty with chordal replacement and quadrangular resection for mitral regurgitation: A prospective randomized controlled study

    Objective To explore the safety, effectiveness, and mid-term efficacy of total thoracoscopic mitral valvuloplasty (MVP) with chordal replacement (CR) and quadrangular resection (QR) for the treatment of mitral regurgitation (MR), and to provide reference for guiding the development and selection of clinical diagnosis and treatment methods for MR patients. Methods A prospective randomized controlled study was performed to collect patients with MR who underwent MVP at the Department of Cardiovascular Surgery, Leshan People's Hospital from January 2021 to March 2022. They were randomly divided into a CR group and a QR group by using a random number table, and were followed up for 12 months after the operation. The medical history, perioperative data and adverse cardiac endpoint events during the follow-up period were collected. The differences in surgical efficacy between the two groups were evaluated and compared, and the Kaplan-Meier method was used to compare the differences in survival rates between the two groups of patients. Results A total of 100 patients were enrolled. There were 46 patients in the CR group, including 27 males and 19 females with an average age of 49.50±9.23 years; there were 46 patients in the QR group, including 24 males and 22 females with an average age of 49.91±11.48 years. The aortic occlusion time in the CR group was longer than that in the QR group (P<0.05). Other surgical indicators, including total surgical time, extracorporeal circulation time, ventilator-assisted time, ICU hospitalization time, size of the valve ring, concomitant surgery during the same period, and the incidence of perioperative complications were not statistically different between the two groups (P>0.05). The left atrium diameter, left ventricular end-diastolic diameter, left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction (LVEF) of the two groups before discharge after the surgery were significantly improved compared to those before surgery (P<0.05). There was a statistical difference in LVEF between the two groups before discharge after the surgery (P<0.05). There was no statistical difference in clinical efficacy between the two groups (P>0.05). Kaplan-Meier analysis showed that the overall incidence of exemption from mild and above mitral regurgitation 12 months after the surgery in the CR group and QR group was 84.8% and 89.1%, respectively. According to the log-rank test, there was no statistical difference in the overall survival curve between the two groups (χ2=0.356, P=0.551). Conclusion CR and QR are both safe and effective methods for the treatment of simple posterior MR.

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  • Effect of different degrees of wound eversion sutures on scar formation at donor site of anterolateral femoral flaps: A prospective randomized controlled study

    Objective To investigate the effect of different degrees of wound eversion on scar formation at the donor site of anterolateral femoral 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 anterior lateral thigh flap 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 and perform corresponding treatments. Thirty of these patients completed follow-up and were included in the final study (18 cases in group A, 23 cases in group B, and 29 cases in group C). 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). The incision healing and scar quality of three groups were compared, as well as the Patient and Observer Scar Assessment Scale (POSAS) score [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. 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 on 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 hypertonic incision proliferative scar formation to some extent.

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