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ObjectiveNon-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas.DesignPatients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital.ResultsTwo hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609±209, TEM 652±188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately €3000 cheaper and therefore more cost-effective.ConclusionUnder the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.

Background For almost 30 years, transanal endoscopic microsurgery (TEM) has been the mainstay treatment for large rectal lesions. With the advent of endoscopic submucosal dissection (ESD), flexible endoscopy has aimed at en bloc R0 resection of superficial lesions of the digestive tract. This systematic review and meta-analysis compared the safety and effectiveness of ESD and full-thickness rectal wall excision by TEM in the treatment of large nonpedunculated rectal lesions preoperatively assessed as noninvasive. Methods A systematic review of the literature published between 1984 and 2010 was conducted (Registration no. CRD42012001882). Data were integrated with those from the original databases requested from the study authors when needed. Pooled estimates of the proportions of patients with en bloc R0 resection, complications, recurrence, and need for further treatment in the ESD and TEM series were compared using random-effects single-arm meta-analysis. Results This review included 11 ESD and 10 TEM series (2,077 patients). The en bloc resection rate was 87.8 % (95 % confidence interval [CI] 84.3–90.6) for the ESD patients versus 98.7 % (95 % CI 97.4–99.3 %) for the TEM patients ( P  < 0.001). The R0 resection rate was 74.6 % (95 % CI 70.4–78.4 %) for the ESD patients versus 88.5 % (95 % CI 85.9–90.6 %) for the TEM patients ( P  < 0.001). The postoperative complications rate was 8.0 % (95 %, CI 5.4–11.8 %) for the ESD patients versus 8.4 % (95 % CI 5.2–13.4 %) for the TEM patients ( P  = 0.874). The recurrence rate was 2.6 % (95 % CI 1.3–5.2 %) for the ESD patients versus 5.2 % (95 % CI 4.0–6.9 %) for the TEM patients ( P  < 0.001). Nevertheless, the rate for the overall need of further abdominal treatment, defined as any type of surgery performed through an abdominal access, including both complications and pathology indications, was 8.4 % (95 % CI 4.9–13.9 %) for the ESD patients versus 1.8 % (95 % CI 0.8–3.7 %) for the TEM patients ( P  < 0.001). Conclusions The ESD procedure appears to be a safe technique, but TEM achieves a higher R0 resection rate when performed in full-thickness fashion, significantly reducing the need for further abdominal treatment.

Intraoperative MRI is increasingly used in neurosurgery, although there is little evidence for its use. We aimed to assess efficacy of intraoperative MRI guidance on extent of resection in patients with glioma. In our prospective, randomised, parallel-group trial, we enrolled adults (≥18 years) with contrast enhancing gliomas amenable to radiologically complete resection who presented to Goethe University (Frankfurt, Germany). We randomly assigned patients (1:1) with computer-generated blocks of four and a sealed-envelope design to undergo intraoperative MRI-guided surgery or conventional microsurgery (control group). Surgeons and patients were unmasked to treatment group allocation, but an independent neuroradiologist was masked during analysis of all preoperative and postoperative imaging data. The primary endpoint was rate of complete resections as established by early postoperative high-field MRI (1·5 T or 3·0 T). Analysis was done per protocol. This study is registered with ClinicalTrials.gov, number NCT01394692. We enrolled 58 patients between Oct 1, 2007, and July 1, 2010. 24 (83%) of 29 patients randomly allocated to the intraoperative MRI group and 25 (86%) of 29 controls were eligible for analysis (four patients in each group had metastasis and one patient in the intraoperative MRI group withdrew consent after randomisation). More patients in the intraoperative MRI group had complete tumour resection (23 [96%] of 24 patients) than did in the control group (17 [68%] of 25, p=0·023). Postoperative rates of new neurological deficits did not differ between patients in the intraoperative MRI group (three [13%] of 24) and controls (two [8%] of 25, p=1·0). No patient for whom use of intraoperative MRI led to continued resection of residual tumour had neurological deterioration. One patient in the control group died before 6 months. Our study provides evidence for the use of intraoperative MRI guidance in glioma surgery: such imaging helps surgeons provide the optimum extent of resection. None.

Unilateral vestibular schwannomas have a lifetime prevalence exceeding 1 case per 500 persons. The unpredictable clinical behavior of these tumors and limited high-level evidence, plus associated quality-of-life factors, render current management controversial.

Background The unilateral biportal endoscopic (UBE) technique is a minimally invasive procedure for spinal surgery, while open microscopic discectomy is the most common surgical treatment for ruptured or herniated discs of the lumbar spine. A new endoscopic technique that uses a UBE approach has been applied to conventional arthroscopic systems for the treatment of spinal disease. In this study, we aimed to compare and evaluate the perioperative parameters and clinical outcomes, including recovery from surgery, pain and life quality modification, patient’s satisfaction, and complications, between UBE and open lumbar microdiscectomy (OLM) for single-level discectomy procedures. Methods This study included 141 patients with degenerative disc disease requiring discectomy at a single level from L2–L3 to L5–S1. A total of 60 and 81 patients underwent UBE and OLM, respectively. Analysis was based on comparison of perioperative metrics, operation time (OT); estimated blood loss (EBL); length of hospital stay (HS); clinical outcomes, including assessment using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI); patient satisfaction (the MacNab score); and the incidence of reoperation and complications. Results The study cohort was 56.7% women, and the mean patient age was 50.98 ± 18.23 years. The mean VAS (the back and leg), MacNab score, and ODI improved significantly from the preoperative period to the last follow-up (12.92 ± 3.92) in both groups ( p  < 0.001). One week after operation, the back VAS score in the UBE group showed significantly more improvement than that in the OLM group. However, the 1-week, 3-month, and 12-month VAS (the back and leg), ODI improvement, modified MacNab score, and OT were not significantly different between the two groups. In the UBE group, EBL (34.67 ± 16.92) was smaller and HS (2.77 ± 1.2) was shorter than that of the OLM group (140.05 ± 57.8, 6.37 ± 1.39). However, OT (70.15 ± 22.0) was longer in the UBE group than in the OLM group (60.38 ± 15.5), and the difference was statistically significant. Meanwhile, the differences in the rate of surgical conversion and complications between the two groups were not statistically significant. Conclusions The UBE for single-level discectomy yielded similar clinical outcomes to OLM, including pain control, functional disability, and patient satisfaction, but incurred minimal EBL, HS, and postoperative back pain. Trial registration Not applicable.

Background and objectiveThe optimal management of large vestibular schwannomas continues to be debated. We constituted a task force comprising the members of the EANS skull base committee along with international experts to derive recommendations for the management of this problem from a European perspective.Material and methodsA systematic review of MEDLINE database, in compliance with the PRISMA guidelines, was performed. A subgroup analysis screening all surgical series published within the last 20 years (January 2000 to March 2020) was performed. Weighted summary rates for tumor resection, oncological control, and facial nerve preservation were determined using meta-analysis models. This data along with contemporary practice patterns were discussed within the task force to generate consensual recommendations regarding preoperative evaluations, optimal surgical strategy, and follow-up management.ResultsTumor classification grades should be systematically used in the perioperative management of patients, with large vestibular schwannomas (VS) defined as > 30 mm in the largest extrameatal diameter. Grading scales for pre- and postoperative hearing (AAO-HNS or GR) and facial nerve function (HB) are to be used for reporting functional outcome. There is a lack of consensus to support the superiority of any surgical strategy with respect to extent of resection and use of adjuvant radiosurgery. Intraoperative neuromonitoring needs to be routinely used to preserve neural function. Recommendations for postoperative clinico-radiological evaluations have been elucidated based on the surgical strategy employed.ConclusionThe main goal of management of large vestibular schwannomas should focus on maintaining/improving quality of life (QoL), making every attempt at facial/cochlear nerve functional preservation while ensuring optimal oncological control, thereby allowing to meet patient expectations. Despite the fact that this analysis yielded only a few Class B evidences and mostly expert opinions, it will guide practitioners to manage these patients and form the basis for future clinical trials.

BackgroundPromoting a disruptive innovation in microsurgery, exoscopes promise alleviation of physical strain and improved image quality through digital visualization during microneurosurgical interventions. This study investigates the impact of a novel 3D4k hybrid exoscope (i.e., combining digital and optical visualization) on surgical performance and team workflow in preclinical and clinical neurosurgical settings.MethodsA pre-clinical workshop setting has been developed to assess usability and implementability through skill-based scenarios (neurosurgical participants n = 12). An intraoperative exploration in head and spine surgery (n = 9) and a randomized clinical study comparing ocular and monitor mode in supratentorial brain tumor cases (n = 20) followed within 12 months. Setup, procedure, case characteristics, surgical performance, and user experience have been analyzed for both ocular group (OG) and monitor group (MG).ResultsBrain tumor cases using frontal, frontoparietal, or temporal approaches have been identified as favorable use cases for introducing exoscopic neurosurgery. Mean monitor distance and angle were 180 cm and 10°. Surgical ergonomics when sitting improved significantly in MG compared with OG (P = .03). Hand-eye coordination required familiarization in MG. Preclinical data showed a positive correlation between lateral camera inclination and impact on hand-eye coordination (rs = 0.756, P = .01). There was no significant added surgical time in MG. Image quality in current generation 3D4k monitors has been rated inferior to optic visualization yet awaits updates.ConclusionsThe hybrid exoscopic device can be integrated into established neurosurgical workflows. Currently, exoscopic interventions seem most suited for cranial tumor surgery in lesions that are not deep-seated. Ergonomics improve in monitor mode compared to conventional microsurgery.

Achieving precision in microsurgery requires skill, adequate instruments and magnification, as well as extensive training. Dedicated surgical robotic systems have enhanced and expanded the application of (super-)microsurgical techniques by introducing motion scaling and providing improved surgeon ergonomics. In this prospective preclinical trial, we analyzed the learning curve in robotic assisted microsurgery in 13 participants including medical students, residents, and attending physicians. Data on demographics as well as prior experience in surgery, microsurgery, and gaming were collected. In three study sessions, the participants performed nine microsurgical anastomoses each on 2 mm vessel models using the Symani ® Surgical System in combination the VITOM 3D exoscope. A senior expert microsurgeon reviewed the de-identified and blinded videos and scored all anastomoses using a modified “Structured Assessment of Microsurgical Skills” (SARMS) score. All participants significantly reduced their time needed per anastomosis and their overall SARMS score, as well as individual scores for motion and speed throughout the trial. We saw a significant correlation of prior years of practice in surgery with the overall mean time and mean SARMS score. In a separate analysis of the three sessions, this influence could no longer be seen in the last session. Furthermore, we found no significant effect of gender, age, hand dominance, or gaming experience on speed and quality of the anastomoses. In this study of 117 robotic assisted anastomoses, a rapid improvement of performance of all participants with different surgical skills levels could be shown, serving as encouraging evidence for further research in the implementation of microsurgical robotic systems.

AbstractObjectiveTo assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation.DesignMulticentre randomised controlled trial with non-inferiority design.SettingFour hospitals in the Netherlands.Participants613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial.InterventionsPTED (n=179) compared with open microdiscectomy (n=309).Main outcome measuresThe primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses.ResultsAt 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis.ConclusionsPTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica.Trial registrationNCT02602093ClinicalTrials.gov NCT02602093.