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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.

Skin antisepsis with iodine povacrylex resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in patients with closed limb fractures but not in those with open fractures.

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.

Breast cancer related lymphedema (BCRL) is a chronic condition with a detrimental impact on psychosocial and physical well-being. Lymphaticovenous anastomosis has shown promising results in alleviating physical symptoms and increasing quality of life in patients with BCRL. The aim of the study is to evaluate the effect on health related quality of life (HrQol) after LVA surgery versus conservative treatment in patients with BCRL. The study is a prospective, multicenter randomized controlled trial. Adult women with unilateral BCRL, with early stage lymphedema and viable lymphatic vessels were included. The primary outcome measure was HrQol measured by the lymphedema functioning disability and health (Lymph-ICF) questionnaire. The secondary outcomes were volume difference measured by the water displacement method; the Upper Extremity Lymphedema (UEL) index; and daily use of the compression garments after 3 and 6 months. For this interim analysis 46 patients per group were included. There was a significant improvement in the domains in physical and mental function in the Lymph-ICF questionnaire in the LVA group after 6 months, (− 16.46 ± 18.5, p < 0.05, − 10.12 ± 29.5, p < 0.05 respectively). However, there was no statistical difference in the total score of the Lymph-ICF after 6 months in both groups (LVA-group; − 8.57 ± 22.6, p > 0.05, CDT-group; − 2.65 ± 18.2, p < 0.05). Furthermore, there was no significant volume reduction in both groups (LVA-group: 20.04 ± 196.40, p = 0.497, CDT: 33.98 ± 189.87, p = 0.236). In the LVA group, 41% partially of completely stopped wearing the compression garments after six months whereas in the CDT group 0% discontinued to use of compression garments. LVA resulted in improvement of the domains physical and mental function of the Lymph-ICF. Limb volume did not significantly improve after 6 months. However, around 42% could completely or partially stopped with the use of compression garments in the LVA group. The current results are promising, however longer follow up is required to assess long term effect of LVA for secondary lymphedema. Clinical Trial Registration : NCT02790021 registered on 03/06/2016

Background Cerebral palsy (CP), which is characterized by movement and posture disorders, is a neurological disorder that affects the movement of both the lower and upper extremities. Current research on gait analysis in children with cerebral palsy is mostly focused on the lower extremities, whereas research on the upper extremities is limited to three-dimensional gait analysis. However, in many countries, video-based gait analysis is used instead of three-dimensional gait analysis owing to its high cost. The primary aim of this study was to determine whether upper extremity kinematics change after lower extremity surgery in children with cerebral palsy. As a secondary aim, we developed a video-based analysis method to assess these changes in settings where 3D gait analysis is not available. Methods The study included 30 children (17 diplegic and 13 hemiplegic including 18 boys and 12 girls) with a mean age of 8.9 years and 29 healthy children (15 boys and 14 girls) with a mean age of 9.3 years. The efficacy of the surgical procedure was determined using Edinburgh Visual Gait Scores before and after surgery. Bilateral upper limb kinematics, including wrist, elbow, shoulder, trunk, and head flexion/extension angles, as well as trunk and head lateral flexion and shoulder abduction in the coronal plane, were measured during the initial contact and mid-stance phases using Kinovea 0.9.5 software by 2 different observers. Measurements from the more and less affected sides in the CP group were compared with corresponding limbs of the healthy control group. Preoperative, postoperative, and control groups were compared by ANOVA. The ICC test was used to evaluate the interobserver reliability between the 2 observers. Wilcoxon signed-rank test was used to compare EVGS scores. Results Postoperative outcomes at the wrist and elbow were found to differ in the sagittal plane, with notable adjustments in the flexion/extension angles during the initial contact and midstance phases. In addition, compared with those in the preoperative phase, the Edinburgh Scale (Edinburgh) score showed favorable postoperative improvements. Postoperative improvements were observed in wrist and elbow kinematics, with values approaching those of the control group. Interobserver reliability was excellent for most sagittal plane measurements (ICC > 0.90). Conclusions This study revealed changes in the kinematics of the upper extremities after lower extremity surgery. These findings demonstrates that video-based analysis can provide reliable measurements of upper limb kinematics in settings where 3D gait analysis is not available. Trial registration This study was registered with ClinicalTrials.gov, number NCT05957783, titled “Changes in Upper Limb Kinematics in Children with Cerebral Palsy After Lower Limb Surgery.” The trial was publicly registered on 07/24/2023 to ensure transparency and reproducibility of the research process. Although the data were analyzed retrospectively, the study protocol was prospectively registered at ClinicalTrials.gov (NCT05957783) to ensure transparency. The party responsible for the trial registration was Yaşar Samet Gökçeoğlu, which is contactable via sametgokceoglu@gmail.com.

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.

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.

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.

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.