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The optimal surgical excision margins are uncertain for patients with thick (>2 mm) localised cutaneous melanomas. In our previous report of this multicentre, randomised controlled trial, with a median follow-up of 6·7 years, we showed that a narrow excision margin (2 cm vs 4 cm) did not affect melanoma-specific nor overall survival. Here, we present extended follow-up of this cohort. In this open-label, multicentre randomised controlled trial, we recruited patients from 53 hospitals in Sweden, Denmark, Estonia, and Norway. We enrolled clinically staged patients aged 75 years or younger diagnosed with localised cutaneous melanoma thicker than 2 mm, and with primary site on the trunk or upper or lower extremities. Patients were randomly allocated (1:1) to treatment either with a 2-cm or a 4-cm excision margin. A physician enrolled the patients after histological confirmation of a cutaneous melanoma thicker than 2 mm. Some patients were enrolled by a physician acting as responsible for clinical care and as a trial investigator (follow-up, data collection, and manuscript writing). In other cases physicians not involved in running the trial enrolled patients. Randomisation was done by telephone call to a randomisation office, by sealed envelope, or by computer generated lists using permuted blocks. Patients were stratified according to geographical region. No part of the trial was masked. The primary outcome in this extended follow-up study was overall survival and the co-primary outcome was melanoma-specific survival. All analyses were done on an intention-to-treat basis. The study is registered with ClinicalTrials.gov, number NCT03638492. Between Jan 22, 1992, and May 19, 2004, 936 clinically staged patients were recruited and randomly assigned to a 4-cm excision margin (n=465) or a 2-cm excision margin (n=471). At a median overall follow-up of 19·6 years (235 months, IQR 200–260), 621 deaths were reported—304 (49%) in the 2-cm group and 317 (51%) in the 4-cm group (unadjusted HR 0·98, 95% CI 0·83–1·14; p=0·75). 397 deaths were attributed to cutaneous melanoma—192 (48%) in the 2-cm excision margin group and 205 (52%) in the 4-cm excision margin group (unadjusted HR 0·95, 95% CI 0·78–1·16, p=0·61). A 2-cm excision margin was safe for patients with thick (>2 mm) localised cutaneous melanoma at a follow-up of median 19·6 years. These findings support the use of 2-cm excision margins in current clinical practice. The Swedish Cancer Society, Stockholm Cancer Society, the Swedish Society for Medical Research, Radiumhemmet Research funds, Stockholm County Council, Wallström funds.

In a randomized trial, 3604 patients undergoing nonmajor orthopedic surgery were assigned to receive rivaroxaban or enoxaparin for the period of immobilization after surgery. Venous thromboembolism occurred less frequently with rivaroxaban. There was no significant difference in major bleeding.

BackgroundDexmedetomidine sedation has advantages, such as low incidence of respiratory depression and prolonged block duration, but also significant disadvantages, such as slow onset, high rate of sedation failure, and a long context-sensitive half-life. Remimazolam provides rapid sedation and recovery, high sedation efficacy and has minimal hemodynamic effects. We hypothesized that patients who received remimazolam would require less rescue midazolam than dexmedetomidine.MethodsPatients (n=103) scheduled for surgery under spinal anesthesia were randomized to receive dexmedetomidine (DEX group) or remimazolam (RMZ group) targeting a Modified Observer’s Assessment of Alertness/Sedation score of 3 or 4. Rescue midazolam was administered if the patient failed to be sedated after the initial loading dose or despite infusion rate adjustment.ResultsRescue midazolam administration was significantly higher in the DEX group (0% vs 39.2%; p<0.001). Patients in the RMZ group reached the target sedation level more rapidly. The incidences of bradycardia (0% vs 25.5%; p<0.001) and hypertension (0% vs 21.6%; p<0.001) were higher in the DEX group. Respiratory depression occurred at a higher rate in the RMZ group (21.2% vs 2.0%; p=0.002), but no patients required manual ventilation. Patients in the RMZ group recovered faster, had a shorter PACU stay and higher satisfaction scores. Hypotensive episodes in the PACU were more frequent in the DEX group (1.9% vs 29.4%; p<0.001).ConclusionsRemimazolam showed excellent sedation efficacy, minimal hemodynamic effects, and fewer adverse events in the PACU than dexmedetomidine. However, it is important to note that respiratory depression was more frequent with the use of remimazolam.Trial registration number NCT05447507.

To determine the effects of Kinesio taping (KT) on the biomechanical characteristics of the lower limbs during the 90° cutting maneuver in anterior cruciate ligament (ACL) reconstruction (ACLR) athletes. Eighteen ACLR athletes were recruited and subjected randomly to three taping conditions, KT, placebo taping (PT), and no taping (NT), followed by a 90° cutting test. A nine-camera infrared high-speed motion capture system (Vicon, T40, 200 Hz) was used to record the kinematic parameters of the lower limbs during the cutting maneuver, and a three-dimensional dynamometer (Kistler, 1000 Hz) was used to record the kinetic parameters of the lower limbs. A one-way repeated measures analysis of variance was conducted to compare the differences in the lower limb kinematic and kinetic characteristics of ACLR athletes subjected to these interventions. During the landing phase, the knee valgus angle reduced significantly with KT than with NT (95% confidence interval = -1.399 to -0.154; P = 0.025), whereas no significant difference was observed between PT and NT (95% confidence interval = -1.251 to 0.217; P = 0.236). No significant differences were observed in the other kinematic variables among the three taping conditions (P > 0.05). During the landing phase, no significant differences in the kinetic variables were observed among the three taping conditions (P > 0.05). Although KT does not improve the kinetic variables of athletes after ACLR during the 90° cutting maneuver, it reduces the knee valgus angle, which could reduce the risk of secondary ACL injury.

Lower limb lymphedema (LLL) is a common postoperative complication following lymphadenectomy in cervical and endometrial cancers. Removal of the circumflex iliac nodes distal to the external iliac node (CINDEIN) is associated with LLL. Here, we sought to evaluate whether preserving the CINDEIN is helpful in reducing the incidence of LLL in women with cervical and endometrial cancers and to evaluate the safety of preserving CINDEIN. In this prospective randomized controlled trial, patients with clinical stage I A2 to II A cervical cancer and stage I to III endometrial carcinoma undergoing surgery were randomly assigned (1:1) to undergo pelvic lymphadenectomy with CINDEIN removal or preservation. The primary endpoint was the incidence of LLL at 24 months post-surgery. Eligible patients underwent sentinel lymph node (SLN) mapping with carbon nanoparticles (CNP). The study was registered with ClinicalTrials.gov, number ChiCTR2300071911. Between Jun 1, 2017, and Dec 31, 2018, 328 participants were randomly assigned to the two groups. Thirteen patients were excluded from the lymphedema analysis. A total of 158 patients in the CINDEIN preservation group and 157 in the CINDEIN removal group completed the follow-up examination. At baseline, no significant differences were observed between the two groups. The 3-year overall survival rate was 96.9% in the preservation group and 95.7% in the resection group. For cervical cancer and endometrial carcinoma, the incidence of LLL were significantly lower in the preservation group than in the removal group both at 24 months. No differences in the occurrence time of LLL were observed between the two groups. The LLL stages also showed no significant difference between the two groups. In the removal group, no CINDEIN metastases were identified in any patient. A total of 125 evaluable patients received the injection of CNP. None of the patients had CINDEIN detected as SLNs. CINDEIN removal is an important risk factor for LLL following lymphadenectomy in cervical and endometrial cancers. The metastasis rate of CINDEIN in cervical cancer and early endometrial cancer is relatively low, and preserving CINDEIN might be safe and helpful in reducing the occurrence of LLL.

AbstractObjectiveTo examine the associations between neuraxial anaesthesia or general anaesthesia and clinical outcomes, length of hospital stay, and readmission in adults undergoing lower limb revascularisation surgery.DesignComparative effectiveness study using linked, validated, population based databases.SettingOntario, Canada, 1 April 2002 to 31 March 2015.Participants20 988 patients Ontario residents aged 18 years or older who underwent their first lower limb revascularisation surgery in hospitals performing 50 or more of these surgeries annually.Main outcome measuresPrimary outcome was 30 day all cause mortality. Secondary outcomes were in-hospital cardiopulmonary and renal complications, length of hospital stay, and 30 day readmissions. Multivariable, mixed effects regression models, adjusting for patient, procedural, and hospital characteristics, were used to estimate associations between anaesthetic technique and outcomes. Robustness of analyses were evaluated by conducting instrumental variable, propensity score matched, and survival sensitivity analyses.ResultsOf 20 988 patients who underwent lower limb revascularisation surgery, 6453 (30.7%) received neuraxial anaesthesia and 14 535 (69.3%) received general anaesthesia. The percentage of neuraxial anaesthesia use ranged from 0.6% to 90.6% across included hospitals. Furthermore, use of neuraxial anaesthesia declined by 17% over the study period. Death within 30 days occurred in 204 (3.2%) patients who received neuraxial anaesthesia and 646 (4.4%) patients who received general anaesthesia. After multivariable, multilevel adjustment, use of neuraxial anaesthesia compared with use of general anaesthesia was associated with decreased 30 day mortality (absolute risk reduction 0.72%, 95% confidence interval 0.65% to 0.79%; odds ratio 0.68, 95% confidence interval 0.57 to 0.83; number needed to treat to prevent one death=139). A similar direction and magnitude of association was found in instrumental variable, propensity score matched, and survival analyses. Use of neuraxial anaesthesia compared with use of general anaesthesia was also associated with decreased in-hospital cardiopulmonary and renal complications (odds ratio 0.73, 0.63 to 0.85) and a reduced length of hospital stay (−0.5 days, −0.3 to−0.6 days).ConclusionsUse of neuraxial anaesthesia compared with general anaesthesia for lower limb revascularisation surgery was associated with decreased 30 day mortality and hospital length of stay. These findings might have been related to reduced cardiopulmonary and renal complications after neuraxial anaesthesia and support the increased use of neuraxial anaesthesia in patients undergoing these surgeries until the results of a large, confirmatory randomised trial become available.

Background Tourniquets are widely used in limb fracture surgeries. Controversies still exist about the pressure inflated, including unified tourniquet inflation pressure (UTIP) and personalized tourniquet inflation pressure (PTIP). This study evaluated the hemostatic effect between UTIP and PTIP based on systolic blood pressure (SBP) in extremity fracture patients. Materials and methods Patients with fresh extremity fractures requiring tourniquets during surgeries were prospectively enrolled and randomly assigned to the UTIP and PTIP groups. The inflation pressure was set to 250 mmHg for the upper extremities and 300 mmHg for the lower extremities in the UTIP group and SBP plus 50 mmHg for the upper extremities and SBP plus 100 mmHg for the lower extremities in the PTIP group. The primary outcome was a hemostatic effect evaluated by the surgeon (satisfied or dissatisfied). Other secondary outcomes included postoperative changes in limb swelling and tourniquet-related complications. Results A total of 144 patients were enrolled and randomly assigned to the UTIP group or the PTIP group, and each group has 72 patients (36 upper limb and 36 lower limb). Totally, the hemostasis effect of the PTIP group was worse than that of the UTIP group by non-inferiority test. The hemostatic effect of upper limb fractures with SBP plus 50 mmHg for tourniquet inflation pressure was also worse than that with 250mmHg; however, there was no statistically significant difference between 300mmHg and SBP plus 100 mmHg in the lower limb group hemostasis effect due to a lack of power. Also, no difference was observed in the incidence of complications ( p  = 1.000) and postoperative changes in limb swelling during 2 days after surgery (upper limb: P1 = 0.546, P2 = 0.545; lower limb: P1 = 0.408, P2 = 0.857) between the PTIP and UTIP group. Conclusion In the surgery of limb fractures, setting SBP + 50mmHg as tourniquet pressure may not be sufficient for upper limbs. Also, we found no difference between the SBP + 100mmHg and the unified 300mmHg for lower limb surgeries.

The purpose of this study was to test whether differences in muscle activity patterns between anterior cruciate ligament-reconstructed patients (ACLR) and healthy controls could be detected 10 to 15 years post-surgery using a machine learning classification approach. Eleven ACLR subjects and 12 healthy controls were recruited from an ongoing prospective randomized clinical trial. Surface electromyography (EMG) signals were recorded from gastrocnemius medialis and lateralis, tibialis anterior, vastus medialis, rectus femoris, biceps femoris, and semitendinosus muscles. Muscle activity was analyzed using wavelet analysis and examined within four sub-phases of the hop test, as well as an average of the task as a whole. K-nearest neighbor machine learning combined with a leave-one-out validation was used to classify the muscle activity patterns as either ACLR or Control. When muscle activity was averaged across the whole hop task, activity patterns for all muscles except the tibialis anterior were identified as being different between the study cohorts. ACLR patients demonstrated continuous muscle activities that spanned take-off, airborne, and landing hop phases versus healthy controls who displayed timed and regulated islets of muscle activities specific to each hop phase. The most striking features were 25–50% greater relative quadriceps intensity and approximately 66% diminished biceps femoris intensity in ACLR patients. The current findings are in contrast to previous work using conventional co-contraction and muscle activation onset EMG measures of the same dataset, underscoring the sensitivity and potential of the wavelet approach coupled with machine learning to reveal meaningful adaptation strategies in this at-risk population.

This research was conducted to construct an ankle pump motion counter and system with orthopedic characteristics and analyze the impacts of fast-track surgery on postoperative deep venous thrombosis (DVT) among patients with lower limb fractures. First, an ankle pump motion counter system was set up to detect postoperative rehabilitation training (Hardware design: This involves components such as an accelerometer sensor, microcontroller, circuit design, power supply, and wireless module. The accelerometer sensor is used to monitor key points and capture motion signals, while the microcontroller handles frequency calculations and generates alerts for abnormal ankle pump motion parameters. Circuit design ensures the proper functioning of the device, and the power supply meets the requirements of the ankle pump motion counter. The wireless module is used for data transmission and communication with other devices. Software design: This includes software design for both the patient and doctor sides. The software design involves defining software requirements and module divisions, designing data acquisition and filtering programs, developing programs for data parameter reading and writing, implementing communication protocols, designing data communication programs, and creating rehabilitation training plans and training record programs). Then, a retrospective analysis was carried out for the subjects (100 patients with lower limb fractures treated in Zhejiang Hospital between June 2021 and June 2022. They were randomly enrolled into control and experimental groups (50 cases each). The ankle pump motion counter was utilized for the patients in the experimental group. Before surgery, gender, age, the incidence of venous thromboembolism (VTE), and the muscle strength of both lower limbs of the two groups were recorded. After surgery, numerical rating scale (NRS) pain scores, D-dimer (D-D), and average length of hospitalization 3 d after surgery and venous thrombosis of both lower limbs 5 d after surgery of two groups were compared. D-D of the control group was significantly higher than that of the experimental group 3 days after surgery (P < .05), while the NRS pain score was relatively lower (P < .05). The average hospitalization length for the experimental group was 10.2 days versus 16.2 days for the control group. The incidence of VTE 5 days after the surgery was 2% for the experimental group compared to 6% for the control group (P < .05). The ankle pump motion counter system has the potential to improve VTE prevention, enhance patient compliance, streamline healthcare delivery, standardize care, and enable data-driven decision-making at a wider clinical level. By accurately monitoring ankle pump exercises and providing real-time feedback, this system can contribute to better patient outcomes, save time for healthcare providers, and facilitate evidence-based practices in the prevention of postoperative DVT among patients with lower limb fractures.

Various advantages of isobaric bupivacaine, levobupivacaine, and hyperbaric bupivacaine are described. There are no studies reliably determining the benefits of these forms of bupivacaine. The purpose of the study was to compare the efficacy of spinal anesthesia (SA) performed with 0.5% isobaric bupivacaine, 0.5% levobupivacaine, and 0.5% hyperbaric bupivacaine. The clinical study was approved by the ethics committee. The sample size was calculated for a confidence level of 99%. 111 patients were randomly allocated into 3 equal groups for spinal anesthesia in lower limb surgeries. In group 1 (1B) spinal anesthesia was performed with 3 ml of 0.5% isobaric bupivacaine (n = 37); in group 2 (2L)—3 ml of 0.5% levobupivacaine (n = 37), in group 3 (3H)—3 ml of 0.5% hyperbaric bupivacaine (n = 37). The criterion for assessing the effectiveness of anesthesia was the need to switch to another type of anesthesia (criterion-no anesthesia), or the need for additional use of narcotic analgesics or local anesthesia during surgery (criterion-reporting of painful feelings during the operation). In 1B anesthesia efficiency by the criterion of additional intraoperative analgesia was 100% (37 patients; 95% CI [0.88–1.0]); 2L—86.4%; (31 patients; 95% CI [0.68–0.92]); 3H—72.9% (27 patients; 95% CI [0.56–0.84]). There were significant differences between groups 1B and 2L: p < 0.05 (p = 0.0104). There were no significant differences between groups 2L and 3H (p = 0.2587). All patients in group 1B developed complete sensory block (++) within 4 (3; 5) min. In group 2L complete sensory block developed in 34 patients (89.4%) within 9 (5; 14) min, in group 3H sensory block developed in all patients within 3 (2.5; 4). The duration of analgesia period between 1B and 2L did not statistically differ (p = 0.73). In 3H the duration of analgesia was 170 (150; 200) min. The study found 83.7% efficacy of levobupivacaine and 72.9% efficacy of hyperbaric bupivacaine in comparison with isobaric bupivacaine (100%) when administered intrathecally in equal volumes and amounts (by the criterion of additional intraoperative analgesia). Trial registration: NCT05184465 (Initial Release: 12/01/2021; date of first publication—11/01/2022).