ABSTRACT
PURPOSE: To study behaviour of endonasally operated non-functioning pituitary adenomas (NFPA) and propose a cost-effective stratified follow-up regimen. METHODS: A single centre retrospective cohort analysis from June 2009 till December 2019. All endonasally operated pituitary adenomas were identified with sub-analysis of the NFPA's. Patients of all age groups with radiological follow-up more than 30 months were included. Patients with any kind of cranial intervention performed < within 30 months of surgery were excluded. The post-operative MRI for this cohort was evaluated until either any intervention was performed or until the last follow-up. The maximal tumour diameter in any plane (mm) was measured from the MRI scans. The annual growth rate and the statistical relationship between age, sex, IHC, Ki-67, resection %, residual tumour was calculated. RESULTS: Out of 610 pituitary adenomas identified in the dataset, 116 patients met the inclusion criteria. Follow-up period ranged from 30 to 142 months (mean 78.5 months). A strong relationship existed between predicting tumour progression with first post-operative residue size (p = .001). A statistically significant relationship was found to be present between tumour growth and a residue of less than 10 mm diameter and 11-20 mm in diameter (Log rank p value .0216). On average, each patient with a residue < 5mm had MRI scans costing 976 £. CONCLUSION: Based on statistical analysis and internal validation of the growth rate of the residue, we have proposed MRI follow-up scans. These recommendations have the potential to save more than 300 £per patient towards MRI costs and can lay down a marker for defining time interval of serial scans for post-operative NFPA's.
ABSTRACT
OBJECTIVE: Quantitative data on visual outcomes after trans-sphenoidal surgery is lacking in the literature. This study aims to address this by quantitatively assessing visual field outcomes after endoscopic trans-sphenoidal pituitary adenectomy using the capabilities of modern semi-automated kinetic perimetry. METHODS: Visual field area (deg2) calculated on perimetry performed before and after surgery was statistically analysed. Functional improvement was assessed against UK driving standards. RESULTS: Sixty-four patients (128 eyes) were analysed (May 2016-Nov 2019). I4e and I3e isopter area significantly increased after surgery (p < 0.0001). Of eyes with pre-operative deficits: 80.7% improved and 7.9% worsened; the median amount of improvement was 60% (IQR 6-246%). Median increase in I4e isopter was 2213deg2 (IQR 595-4271deg2) and in I3e isopter 1034 deg2 (IQR 180-2001 deg2). Thirteen out of fifteen (87%) patients with III4e data regained driving eligibility after surgery. Age and extent of resection (EOR) did not correlate with visual improvement. Better pre-operative visual field area correlated with a better post-operative area (p < 0.0001). However, the rate of improvement in the visual field area increased with poorer pre-operative vision (p < 0.0001). CONCLUSIONS: A median visual field improvement of 60% may be expected in over 80% of patients. Functionally, a significant proportion of patients can expect to regain driving eligibility. EOR did not impact on visual recovery. When the primary goal of surgery is alleviating visual impairment, optic apparatus decompression without the aim for gross total resection appears a valid strategy. Patients with the worst pre-operative visual field often experience the greatest improvement, and therefore, poor pre-operative vision alone should not preclude surgical intervention.
Subject(s)
Visual Field Tests , Visual Fields , Endoscopy , Eye , Humans , Pituitary GlandABSTRACT
BACKGROUND: Aerosol is a health risk to theatre staff. This laboratory study quantifies the reduction in particulate matter aerosol concentrations produced by electrocautery and drilling when using mitigation strategies such as irrigation, respirator filtration and suction in a lab environment to prepare for future work under live OR conditions. METHODS: We combined one aerosol-generating procedure (monopolar cutting or coagulating diathermy or high-speed diamond- or steel-tipped drilling of cadaveric porcine tissue) with one or multiple mitigation strategies (instrument irrigation, plume suction and filtration using an FFP3 respirator filter) and using an optical particle counter to measure particulate matter aerosol size and concentrations. RESULTS: Significant aerosol concentrations were observed during all aerosol-generating procedures with concentrations exceeding 3 × 106 particles per 100 ml. Considerable reductions in concentrations were observed with mitigation. In drilling, suction, FFP3 filtration and wash alone respectively reduced aerosol by 19.3-31.6%, 65.1-70.8% and 97.2 to > 99.9%. The greatest reduction (97.38 to > 99.9%) was observed when combining irrigation and filtration. Coagulating diathermy reduced concentrations by 88.0-96.6% relative to cutting, but produced larger particles. Suction alone, and suction with filtration reduced aerosol concentration by 41.0-49.6% and 88.9-97.4% respectively. No tested mitigation strategies returned aerosol concentrations to baseline. CONCLUSION: Aerosol concentrations are significantly reduced through the combined use of filtration, suction and irrigation. Further research is required to characterise aerosol concentrations in the live OR and to find acceptable exposure limits, and in their absence, to find methods to further reduce exposure to theatre staff.
Subject(s)
Particulate Matter , Aerosols/analysis , Animals , Suction , Swine , Ventilators, MechanicalABSTRACT
INTRODUCTION: We describe our technique of using reverse frontal bone graft for FOAR for patients with metopic or coronal synostosis and present our complications using the Leeds classification system for complications in craniosynostosis surgery. METHODS: Since April 2015, seventeen patients have been operated using this technique. We perform a frontal bone graft that is then reversed, and supraorbital margins are drilled out. The orbital bar is then removed and drilled down to make bone dust and on-lay bone grafts which are then used to fill gaps on exposed dura and fill in around the temporal region. RESULTS: All 17 patients who underwent this technique have good cosmetic results. We report 5 (29%) complications and 8 (47%) blood transfusions (7 exposures, 1 cell salvage).
Subject(s)
Craniosynostoses , Plastic Surgery Procedures , Bone Transplantation , Craniosynostoses/diagnostic imaging , Craniosynostoses/surgery , Frontal Bone/diagnostic imaging , Frontal Bone/surgery , Humans , Infant , Orbit/diagnostic imaging , Orbit/surgeryABSTRACT
BACKGROUND: Enhanced recovery after surgery (ERAS) is a constant motivation. There is growing evidence that an endoscopic (rather than microscopic) transsphenoidal approach to pituitary tumours can play a role, facilitating faster recovery and a commensurate reduction in length of stay (LOS). Reducing LOS is beneficial to both patients and healthcare systems. We sought to assess the safety, patient feedback, and resource implications of adopting an enhanced recovery and accelerated discharge policy for elective pituitary surgery. METHODS: We retrospectively assessed two consecutive cohorts of patients undergoing elective surgery for pituitary adenoma in a single UK centre between July 2016 and November 2019. The pre-ERAS cohort included 52 sequential patients operated prior to protocol change. The ERAS cohort included 55 sequential patients operated after a protocol change. Patient demographic data, tumour characteristics, intra- and post-operative CSF leak, the rate and cause of readmission (within 30 days), and the mean and median LOS were recorded. Patient feedback was collected from a subset of patients (n = 23) in the ERAS group. RESULTS: The two cohorts were well-matched with respect to their demographic, pathological, and operative characteristics. The rates of readmission within 30 days of discharge were similar between the two groups (8% pre-ERAS cohort, 9% ERAS cohort, p = 0.75). In the pre-ERAS cohort, the mean LOS was 4.5 days and median LOS was 3 days. This compares with significant reduction in LOS for the ERAS group: mean of 1.7 days and median of 1 day (p < 0.05). Thirty-nine of 55 patients in the ERAS group were discharged on post-operative day 1. Patient feedback was very positive in the ERAS group (mean patient satisfaction score of 9.7/10 using a Likert scale). CONCLUSIONS: An enhanced recovery protocol after elective endoscopic pituitary surgery is safe, reduces length of stay, and is associated with high patient satisfaction.
Subject(s)
Elective Surgical Procedures/adverse effects , Endoscopy/adverse effects , Neurosurgical Procedures/adverse effects , Patient Reported Outcome Measures , Pituitary Neoplasms/surgery , Postoperative Complications/epidemiology , Adult , Aged , Costs and Cost Analysis , Elective Surgical Procedures/economics , Endoscopy/economics , Female , Humans , Length of Stay , Male , Middle Aged , Neurosurgical Procedures/economics , Patient Discharge , Postoperative Complications/economicsABSTRACT
Ischemic spinal cord infarction is rare in the paediatric population, and when it does occur, it is usually associated with traumatic injury. Other potential causes include congenital cardiovascular malformations, cerebellar herniation, thromboembolic disease and infection. Magnetic resonance imaging (MRI) findings can be subtle in the early evaluation of such patients. The outcome is variable and depends on the level and extent of the spinal cord infarct and subsequent rehabilitation. Here, we present two cases of ischemic spinal cord infarction in children.
Subject(s)
Infarction/pathology , Spinal Cord/blood supply , Child, Preschool , Female , Follow-Up Studies , Humans , Infant , Infarction/diagnostic imaging , Infarction/rehabilitation , Infarction/surgery , Magnetic Resonance Imaging , Male , Spinal Cord/diagnostic imagingABSTRACT
Pregnancy-associated breast cancer (PABC) has been defined as breast cancer diagnosed during pregnancy or within one year of delivery. It is believed that after adjusting for age and stage, the 5-year survival rates are the same in both pregnant and nonpregnant women. We conducted a retrospective case-control study among patients treated at our institution between 1990 and 2005 to compare the 5-year survival outcomes for PABC with women treated for breast cancer who were not pregnant. Overall survival (OS) and disease-free survival (DFS) were estimated by the Kaplan-Meier method, and log rank tests were used to assess the associations between OS, DFS and pregnancy status, HER-2 status, ER/PR status, and family history. The median age was 33 years (range 24-42) for both groups. Twenty-two (55%) patients with PABC were ER/PR receptor positive compared with 20 (50%) for the controls. Ninety percent of patients with PABC received chemotherapy compared with 87.5% in the nonpregnant group. 91.5% of patients with PABC had breast-conserving surgery and 8.5% had mastectomies compared with 86% and 14%, respectively, for the control group. The median OS was 4.9 years in the PABC group compared with 6 years for the controls (p = 0.02). The median DFS was 2.7 years for the PABC group compared with 5.1 years for the controls (p = 0.01). The most common site of relapse was bone for the PABC group (27%) and local recurrence (33%) for the controls. Univariate analysis revealed that OS and DFS were associated with pregnancy status, family history, ER/PR status, and stage. After adjusting for age and stage, PABC patients had higher risk of both death (p = 0.01) and recurrence (p = 0.02) compared with nonpregnant controls. Women with PABC had significantly shorter OS and DFS compared with nonpregnant age and stage-matched controls.
Subject(s)
Breast Neoplasms/mortality , Pregnancy Complications, Neoplastic/mortality , Adult , Breast Neoplasms/drug therapy , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Case-Control Studies , Disease-Free Survival , Female , Humans , Male , Mastectomy, Segmental , Postpartum Period , Pregnancy , Pregnancy Complications, Neoplastic/drug therapy , Pregnancy Complications, Neoplastic/radiotherapy , Pregnancy Complications, Neoplastic/surgery , Receptor, ErbB-2/metabolism , Retrospective Studies , Survival Rate , Treatment OutcomeABSTRACT
At Leeds General Infirmary, a busy tertiary centre for neurosurgery, there has been little visibility of the step-down status of the patients from intensive care to high dependency or from the latter to a ward bed. The only record of the current situation was limited to the paper notes of the bed managers. Furthermore, accuracy of electronic systems used for staffing levels and bed state were underused. There were gaps in information and furthermore information within the system was unreliable (together defined as 'defects'). These defects mandated bed managers' physical presence on each ward to obtain reliable data. This led to unwarranted critical care stays and resultant high rates (up to 40%) of elective operation cancellations requiring a critical care bed.The Leeds Improvement Method using principles of the Toyota Production System aimed to improve patient flow through critical care and to assess the impact on elective case activity. Problems were identified and changes were implemented over a 1-week period. The changes included measures to reduce time taken for collation of critical bed-state information and improving patient and staffing data quality collected in the electronic patient management system (EPMS) and electronic staffing record (ESR). Impact was monitored for 30 days pre-implementation and post-implementation.Following intervention, the time taken by the bed manager to gather live bed-state information decreased from 50 to 9 min; the EPMS storing correct bed-state data was improved from 71% to 0% defect; the ESR was improved from 100% to 4% defects; critical care patient step-downs occurring at night (after 20:00) improved from 80% to 20%; and the number of cancelled elective cases over a 30-day period reduced from nine to one.Implementing these organisational efficiencies can significantly improve critical care patient flow and elective case throughput.
Subject(s)
Critical Care , Efficiency, Organizational , Humans , Monitoring, PhysiologicABSTRACT
Objective Postoperative meningitis is a rare but potentially fatal complication of endoscopic endonasal skull base surgery. Prophylactic antibiotic use varies considerably worldwide. We sought to analyze the safety of a single-agent, single-dose protocol. Design, Setting, and Participants A retrospective review of 422 procedures performed during 404 admission episodes from 2009 to 2019, encompassing sella, parasella, and other anterior skull base pathologies. Main Outcome Measures Primary outcome measure was development of meningitis within 30 days of surgery. Additional information collected: underlying pathological diagnosis, intraoperative cerebrospinal fluid (CSF) leak, postoperative CSF leak, and primary or revision surgery. Results Of 404 admission episodes for endoscopic anterior skull base surgery, 12 cases developed meningitis. Seven had positive CSF cultures and all 12 recovered. For pathology centered on the sella (including pituitary adenoma), the rate of meningitis was 1.1% (3/283). For pathologies demanding an extended approach (including meningioma and craniopharyngioma), the rate of meningitis was 14.5% (9/62). Postoperative CSF leak requiring surgical repair increased the relative risk by 37-fold. There were no cases of meningitis following repair of long-standing CSF fistula or encephalocoele (0/26) and no cases following surgery for sinonasal tumors with skull base involvement (0/33). Conclusion For sella-centered pathologies, a single dose of intravenous co-amoxiclav (or teicoplanin) is associated with rates of meningitis comparable to those reported in the literature. Postoperative meningitis was significantly higher for extended, intradural transphenoidal approaches, especially when postoperative CSF leak occurred. Fastidious efforts to prevent postoperative CSF leak are crucial to minimizing risk of meningitis.
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Hypertrophic osteoarthropathy is characterized by clubbing of the digital tips and periosteal reaction of long bones. Most of the cases are associated with malignancy or other conditions such as congenital heart disease, liver cirrhosis, pulmonary fibrosis, biliary atresia and gastrointestinal polyps. Hypertrophic osteoarthropathy associated with malignancy is rare in children. A few cases of hypertrophic osteoarthropathy in children with nasopharyngeal carcinoma have been reported. This is a case of hypertrophic osteoarthropathy associated with nasopharyngeal carcinoma with lung and bone metastasis in a 16 year old girl. In this case, lung metastases progressed after intensive chemotherapy and hypertrophic osteoarthropathy (Clubbing) persisted.
Subject(s)
Bone Neoplasms/secondary , Carcinoma/complications , Nasopharyngeal Neoplasms/complications , Osteoarthropathy, Secondary Hypertrophic/etiology , Adolescent , Carcinoma/diagnostic imaging , Carcinoma/secondary , Disease Progression , Female , Humans , Lung Neoplasms/diagnostic imaging , Lung Neoplasms/secondary , Nasopharyngeal Neoplasms/diagnostic imaging , Nasopharyngeal Neoplasms/pathology , Tomography, X-Ray ComputedABSTRACT
This paper examines the medico-legal and medico-ethical issues that ethics committees and researchers will have to consider when examining proposals pertaining to non-therapeutic genetic research. This paper is limited to the examination of issues that relate to those individuals who donate bodily/DNA samples for the purposes of non-therapeutic genetic research. The issues that arise are those of (i) informed consent and those with diminished capacity (ii) the drafting of consent forms as they relate to genetic research (iii) confidentiality, genetic research with non-EU countries and the implications of the EC Directive on the Protection of Data: 95/46/EC and (iv) an examination of international ethical guidelines. The paper concludes with (i) a summary of the main points of concern that ethics committees must consider before the approval of genetic research (ii) the manner in which consent forms must be drafted and (iii) a brief look at medico-legal issues that will become important and will have to be considered in Ireland in the near future in relation to genetic research.
Subject(s)
Genetic Research/ethics , Genetic Research/legislation & jurisprudence , Specimen Handling/ethics , Confidentiality , Consent Forms/ethics , Consent Forms/legislation & jurisprudence , DNA , Ethics Committees , Ethics, Research , Humans , Informed Consent/ethics , Informed Consent/legislation & jurisprudence , IrelandABSTRACT
This paper examines some of the medico-legal issues that arose as a result of a situation which occurred in May 2001 in Ireland when a woman who was a British citizen and who was fourteen weeks pregnant collapsed and suffered a brain haemorrhage. She was taken to hospital where she was placed on life support but declared brain-dead. As a result of the uncertainty regarding the hospital's obligation to the foetus, life-support was maintained until further opinion was sought. After two weeks the foetus died and life support was only then discontinued. In Ireland there currently exists neither medical guidelines nor legislation to regulate such areas of medical practice. Also, the courts have not had the opportunity to comment on this particular matter and thus there exists widespread concern as to how healthcare providers will act if such situation were to occur again in the future. This article examines the following difficult medico-legal implications that arise from the above situation and especially in light of the constitutional protection of the unborn child in Ireland.
Subject(s)
Brain Death/legislation & jurisprudence , Fetus , Pregnancy Complications, Cardiovascular , Civil Rights/ethics , Civil Rights/legislation & jurisprudence , Ethics, Clinical , Female , Fetal Viability , Humans , Intracranial Hemorrhages/complications , Intracranial Hemorrhages/mortality , Ireland , Life Support Care/ethics , Life Support Care/legislation & jurisprudence , Patient Advocacy/ethics , Patient Advocacy/legislation & jurisprudence , Patient Rights/ethics , Patient Rights/legislation & jurisprudence , Pregnancy , Pregnancy Complications, Cardiovascular/mortality , Withholding Treatment/ethicsABSTRACT
Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents-Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups-Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.
Subject(s)
Biological Specimen Banks/organization & administration , Biological Specimen Banks/ethics , Biomedical Research/ethics , Documentation/standards , Humans , Information Storage and Retrieval/ethics , Internationality , Ireland , Neoplasms/pathology , RegistriesABSTRACT
The practice of medical research with minors in Ireland consist of practices pertaining to therapeutic and non-therapeutic medical research. Clinical trials (a category of therapeutic research), is governed by legislation. However, any other therapeutic research (non-clinical trials research) and non-therapeutic research, e.g. observational medical research such as a longitudinal study of children or non-therapeutic research such as blood sample collection for analysis of cause of disease, are unregulated by legislation. This, article will outline and describe some of the medico-legal issues involved in both types of research and will comment on matters such as what national law exists, how the directive on good clinical practice has been implemented, what guidelines, if any, exist.
Subject(s)
Biomedical Research/legislation & jurisprudence , Clinical Trials as Topic/legislation & jurisprudence , Ethics, Research , Minors/legislation & jurisprudence , Adolescent , Age Factors , Biomedical Research/ethics , Biomedical Research/standards , Child , Child Welfare , Ethics Committees, Research , Human Rights , Humans , Informed Consent , IrelandABSTRACT
Directive 95/46/EC on the Protection of Individuals with regard to the Processing of Personal Data and on the Free Movement of Such Data has been transposed into national law and is now the Data Protection (Amendment) Act, 2003. The Directive and the transposing Act provide for new obligations to those processing data. The new obligation of primary concern is the necessity to obtain consent prior to the processing of data (Article 7, Directive 95/46/EC). This has caused much concern especially in relation to 'secondary data' or 'archived data'. There exist, what seem to be in the minds of the medical research community, two competing interests: (i) that of the need to obtain consent prior to processing data and (ii) the need to protect and foster medical research. At the same time as the introduction of the Act, other prior legislation, i.e. the Freedom of Information Act, 1997-2003, has encouraged candour within the doctor-patient relationship and the High Court in Ireland, in the case of Geoghegan v. Harris, has promulgated the 'reasonable-patient test' as being the correct law in relation to the disclosure of risks to patients. The court stated that doctors have a duty to disclose all material risks to patients. The case demonstrates an example of a move toward a more open medical relationship. An example of this rationale was also recently seen in the United Kingdom in the House of Lords decision in Chester v. Afshar. Within the medical research community in Ireland, the need to respect the autonomy of patients and research participants by providing information to such parties has also been observed (Sheikh A. A., 2000 and Irish Council for Bioethics, 2005). Disquiet has been expressed in Ireland and other jurisdictions by the medical research communities in relation to the exact working and meaning of the Directive and therefore the transposing Acts (Strobl et al). This may be due to the fact that, as observed by Beyleveld "The Directive makes no specific mention of medical research and, consequently, it contains no provisions for medical research as an explicitly delineated category." (Beyleveld D., 2004) This paper examines the Irish Act and discusses whether the concerns expressed are well-founded and if the Act is open to interpretation such that it would not hamper medical research and public health work.