Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial.

BACKGROUND: Cerebrospinal fluid (CSF) leakage is a frequent and challenging complication in neurosurgery, especially in the posterior fossa, with a prevalence of 8%. It is associated with substantial morbidity and increased healthcare costs. A novel dural sealant patch (LIQOSEAL) was developed for watertight dural closure. The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage in patients undergoing elective posterior fossa intradural surgery with a dural closure procedure compared to the best currently available dural sealants. METHODS: We will conduct a two-arm, randomized controlled, multicenter study with a 90-day follow-up. A total of 228 patients will be enrolled in 19 sites, of which 114 will receive LIQOSEAL and 114 an FDA-approved PEG sealant. The composite primary endpoint is defined as intraoperative CSF leakage at PEEP 20 cm H2O, percutaneous CSF leakage within 90 days of, wound infection within 90 days of or pseudomeningocele of more than 20cc on MRI or requiring intervention. We hypothesize that the primary endpoint will not be reached by more than 10 patients (9%) in the investigational arm, which will demonstrate non-inferiority of LIQOSEAL compared to control. DISCUSSION: This trial will evaluate whether LIQOSEAL is non-inferior to control as a means of reducing CSF leakage and safety TRIAL REGISTRATION: ClinicalTrials.gov NCT04086550 . Registered on 11 September 2019.

Factors related to failure of autologous cranial reconstructions after decompressive craniectomy.

PURPOSE: Cranioplasty is customary after decompressive craniectomy. Many different materials have been developed and used for this procedure. The ideal material does not yet exist, while complication rates in cranioplasties remain high. This study aimed to determine factors related to autologous bone flap failure. MATERIALS AND METHODS: In this two-center retrospective cohort study, 276 patients underwent autologous bone cranioplasty after initial decompressive craniectomy between 2004 and 2014. Medical records were reviewed regarding patient characteristics and factors potentially related to bone flap failure. Data were analyzed using univariable and multivariable regression analysis. RESULTS: Independent factors related to overall bone flap failure were: duration of hospitalization after decompressive craniectomy [OR: 1.012 (95%CI: 1.003-1.022); p = 0.012], time interval between decompressive craniectomy and cranioplasty [OR: 1.018 (95%CI: 1.004-1.032); p = 0.013], and follow-up duration [OR: 1.034 (95%CI: 1.020-1.047); p < 0.001]. In patients with bone flap infection, neoplasm as initial diagnosis occurred significantly more often (29.2% vs. 7.8%; RD 21.3%; 95%CI 8.4 -38.3%; NNH 5; 95%CI 3 -12) and duration of hospitalization after decompressive craniectomy tended to be longer (means 54 vs. 28 days, MD 26.2 days, 95%CI -8.6 to 60.9 days). Patients with bone flap resorption were significantly younger (35 vs. 43 years, MD 7.7 years, 95%CI 0.8-14.6 years) and their cranial defect size tended to be wider than in patients without bone flap resorption (mean circumference 39 vs. 37 cm; MD 2.4 cm, 95% CI -0.43-5.2 cm) and follow-up duration was significantly longer (44 vs. 14 months, MD 29 months, 95%CI 17-42 months). CONCLUSION: A neoplasm as initial diagnosis, longer hospitalization after decompressive craniectomy, larger time interval between decompressive craniectomy and cranioplasty, and longer follow-up duration are associated with a higher risk of failure of autologous bone flaps for cranioplasty. Patients with these risk factors may be better served with an early recovery program after decompressive surgery or an alloplastic material for cranioplasty.

Effects of sterilization on the mechanical properties of poly(methyl methacrylate) based personalized medical devices.

BACKGROUND: Nowadays, personalized medical devices are frequently used for patients. Due to the manufacturing procedure sterilization is required. How different sterilization methods affect the mechanical behavior of these devices is largely unknown. MATERIALS AND METHODS: Three poly(methyl methacrylate) (PMMA) based materials (Vertex Self-Curing, Palacos R+G, and NextDent C&B MFH) were sterilized with different sterilization methods: ethylene oxide, hydrogen peroxide gas plasma, autoclavation, and γ-irradiation. Mechanical properties were determined by testing the flexural strength, flexural modulus, fracture toughness, and impact strength. RESULTS: The flexural strength of all materials was significantly higher after γ-irradiation compared to the control and other sterilization methods, as tested in a wet environment. NextDent C&B MFH showed the highest flexural and impact strength, Palacos R+G showed the highest maximum stress intensity factor and total fracture work. CONCLUSION: Autoclave sterilization is not suitable for the sterilization of PMMA-based materials. Ethylene oxide, hydrogen peroxide gas plasma, and γ-irradiation appear to be suitable techniques to sterilize PMMA-based personalized medical devices.

Treatment of Nonfunctional Pituitary Adenoma Postoperative Remnants: Adjuvant or Delayed Gamma Knife Radiosurgery?

OBJECTIVE: It is still not clear whether Gamma Knife radiosurgery (GKRS) for nonfunctional pituitary adenomas should be used as a standard adjuvant postoperative therapy or applied when there is documented progression of the remnant on follow-up magnetic resonance imaging. METHODS: We performed a retrospective study of patients with nonfunctional pituitary adenomas who underwent primary surgery and GKRS between 2002 and 2015. Patients were divided into 2 groups on the basis of the GKRS indication: adjuvant treatment (GKRS ≤6 months postoperatively) or delayed treatment (GKRS if documented progression occurred on the follow-up magnetic resonance imaging). RESULTS: Fifty patients were included and grouped based on adjuvant (n = 13) or delayed (n = 37) GKRS following primary surgery. The adjuvant and delayed groups had 10-year actuarial tumor control rates of 92% and 96% (P = 0.408), respectively. The 10-year actuarial endocrinologic control rate was 82% for the adjuvant group and 49% for the delayed group (P = 0.597). None of the patients developed any new neurologic deficit post-GKRS. GKRS-induced complications (intratumoral bleeding and tumoral tissue inflammation) occurred in 6% of the patients, of whom 4% were in the delayed group and 2% in the adjuvant group. CONCLUSION: Adjuvant treatment with GKRS yields the same high long-term tumor control as delayed GKRS. Neither adjuvant nor delayed GKRS induced additional neurologic complications. There is a trend that adjuvant GKRS induces less additional endocrinologic deficits compared with delayed GKRS.

Outcome in patient-specific PEEK cranioplasty: A two-center cohort study of 40 implants.

OBJECTIVE: The best material choice for cranioplasty following craniectomy remains a subject to discussion. Complication rates after cranioplasty tend to be high. Computer-assisted 3-dimensional modelling of polyetheretherketone (PEEK) was recently introduced for cranial reconstruction. The aim of this study was to evaluate patient- and surgery-related characteristics and risk factors that predispose patients to cranioplasty complications. MATERIAL AND METHODS: This retrospective study included a total of 40 cranial PEEK implants in 38 patients, performed at two reference centers in the Netherlands from 2011 to 2014. Complications were registered and patient- and surgery-related data were carefully analysed. RESULTS: The overall complication rate of PEEK cranioplasty was 28%. Complications included infection (13 %), postoperative haematoma (10 %), cerebrospinal fluid leak (2.5 %) and wound-related problems (2.5 %). All postoperative infections required removal of the implant. Nonetheless removed implants could be successfully re-used after re-sterilization. CONCLUSION: Although overall complication rates after PEEK cranioplasty remain high, outcomes are satisfactory, as our results compare favourably to recent literature reports on cranial vault reconstruction.

Superficial temporal artery-middle cerebral artery bypass surgery in a pediatric giant intracranial aneurysm presenting as migraine-like episodes.

INTRODUCTION: Aneurysms of the intracranial arteries in the pediatric population are reportedly rare. There is a male predominance, association with connective tissue disorders, as well as bacterial, mycotic infections, and trauma. RESULTS AND DISCUSSION: Common sites of presentation are the internal carotid artery bifurcation, posterior circulation, and distal segment of middle cerebral artery. Clinical manifestations can vary from seizures and subarachnoidal hemorrhage to headache, irritability, lethargy, vomiting, or focal motor deficits. Current treatment modalities encompass endovascular or surgical approach. CONCLUSION: We present a case report on an 11-year-old girl with migraine-like episodes due to an underlying giant fusiform middle cerebral artery aneurysm treated successfully with two superficial temporal artery-middle cerebral artery bypasses.

Endovascular treatment of a giant petrous internal carotid artery aneurysm. Case report and review of the literature.

Expansive aneurysms of the petrous internal carotid artery are rare. Compressive and thrombembolic neurological deficits and occasionally extradural haemorrhage in combination with a pulsatile tinnitus are most important and alarming symptoms. Due to its extradural location, subarachnoid haemorrhage does not occur. Treatment is indicated since rupture may be devastating and recurrent ischaemic attacks severely disabling. Because direct neurosurgical access to the petrous internal carotid artery is very difficult, treatments consists of parent vessel occlusion with or without extra-intracranial bypass construction. We present a case of a young man with a giant petrous artery aneurysm provoking a thrombembolic event which was treated successfully with proximal balloon occlusion of the internal carotid artery after a temporary balloon occlusion test.

Objective pulsatile tinnitus caused by intrapetrous dissecting aneurysm.

Intrapetrosal dissections is a special kind of intracranial dissection since it is located intracranially but extradurally. Only three reports of spontaneous intrapetrosal dissection have been published so far, the posttraumatic intrapetrosal dissections caused by penetrating or blunt trauma not included. Based on the clinical and radiological presentation a treatment with anticoagulantia (a coumarine derivative) was successfully installed. A short review of the major studies concerning intracranial dissection is presented. Firm guidelines for the treatment cannot be provided based on these data but the etiology of the dissection, whether it was posttraumatic or spontaneous, seems to be important. The diagnostic problem of pulsatile tinnitus is briefly discussed.

The use of Emla cream as anaesthetic for minor urological surgery in children.

A number of minor urological surgical procedures can be readily carried out in children in outpatient clinics with the availability of a good topical local anaesthetic. In boys, the separation of preputial adhesions, frenulotomy, meatoplasty, meatal dilatation following circumcision or meatal surgery, the removal of smegma and excision of penile skin lesions can be performed as outpatient treatment. In girls, hymenal abnormalities, meatal abnormalities and labial adhesions come into consideration for its use. Success is dependent on a good estimation of the mental capacity of the child to undergo a local surgical procedure and correct use of the anaesthetic.

Adenocarcinoma of the male urethra with associated nephrogenic metaplasia. Case report and review of the literature.

Nephrogenic metaplasia is an uncommon sequela of chronic bladder irritation. The case described herein represents the second reported in the bulbomembranous urethra of the male. Important questions are raised regarding the premalignant potential of nephrogenic metaplasia. A review of the literature on adenocarcinoma of the male urethra and also of nephrogenic metaplasia of the bladder and urethra is presented.