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Twist-drill craniostomy with hollow screws for evacuation of chronic subdural haematoma
S140
Abstracts / International Journal of Surgery 36 (2016) S138eS143
areas could inform future authors and improve the specialty's evidence base.
0008: THE USE OF STUDY REGISTRATION AND PROTOCOLS IN PLASTIC SURGERY RESEARCH: A SYSTEMATIC REVIEW T.E. Pidgeon 1, 7, *, C. Limb 2, 7, R. Agha 3,7, K. Whitehurst 4,7, C. Chandrakumar 5, 7, G. Wellstead 5, 7, A.J. Fowler 3, 7, D. Orgill 6. 1 St. Andrew's Centre for Plastic Surgery and Burns, Essex, UK; 2 Royal Sussex County Hospital, Brighton and Sussex NHS Trust, Brighton, UK; 3 Guy's and St. Thomas' NHS Foundation Trust, London, UK; 4 University College London Medical School, London, UK; 5 Barts and the London School of Medicine and Dentistry, London, UK; 6 Division of Plastic Surgery, Brigham and Women's Hospital, Boston, USA; 7 The Academic Surgical Collaborative, UK. Background: In 2013, the Declaration of Helsinki mandated that every research study involving human subjects must have its protocol registered in a publicly accessible database prior to the enrolment of the first patient. This systematic review assessed the number of studies published in leading journals of plastic surgery that had either published or registered a protocol with a publicly accessible database. Material and methods: All research articles involving human participants published in Plastic and Reconstructive Surgery, The Journal of Plastic Reconstructive and Aesthetic Surgery and The Annals of Plastic Surgery from 1st April 2014 - 31st March 2015 were examined. The primary outcome measure was whether each study had registered or published a protocol with any mainstream registry database. ClinicalTrials.gov, International Standard Randomised Control Trial Number (ISRCTN), WHO (World Health Organization) International Clinical Trials Registry Platform, The Cochrane Collaboration, the Research Registry, PROSPERO and PubMed were all reviewed. Preliminary results Of 595 included articles, the most common study designs were case series (n¼185, 31.1%). There were 24 randomised controlled trials (RCTs, 4.0%). A total of 24 studies had a protocol registered (4.0%), although no studies had published a protocol in a journal. The most common database to register a protocol was ClinicalTrials.gov (n¼17). The study design that most commonly had a registered protocol was the RCT (n¼8 of 24, 33.3% of RCTs). Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low. There is considerable scope to improve this and relevant guidance is provided.
0011: TWIST-DRILL CRANIOSTOMY WITH HOLLOW SCREWS FOR EVACUATION OF CHRONIC SUBDURAL HAEMATOMA A.G. Kolias 1, 2, *, A. Chari 1, S.J. Bond 2, 3, P.J.A. Hutchinson 1, 2. 1 Division of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK; 2 Cambridge Clinical Trials Unit, Cambridge, UK; 3 MRC Biostatistics Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Objectives: The incidence of chronic subdural haematoma (CSDH) is expected to increase substantially over the next 25 years. Continuing refinement of techniques for surgical evacuation is essential. A novel technique involving a hollow screw, which is threaded through a twistdrill hole in the cranium and then connected to a closed drainage system, has been increasing in popularity. The aim of this systematic review is to collate and analyse available published data. Methods: MEDLINE, Web of Knowledge, EMBASE, and the Cochrane Database were searched for published series involving more than 10 patients. Results: Nine eligible studies were found (6 case series and 3 case-control studies) comprising 796 patients. Seven used the SEPS system (commercially available and manufactured by Medtronic Inc) and 2 studies used the hollow screw (manufactured by Teleflex Medical). The procedures are similar, but the hollow screw procedure uses intra-operative and post-operative (once daily) irrigation routinely to promote brain re-expansion. The SEPS does not use irrigation but relies on a low negative pressure applied through a suction reservoir bulb to promote drainage of the collection and gradual brain reexpansion. Pooled analysis showed a 'success rate' of 77.6% (95% CI 74.6%e 80.4%), recurrence rate of 22.4%, and in-hospital mortality of 1.4%.
Conclusions: On the basis of the available evidence, we believe that this new technique should be systematically assessed according to the IDEAL framework. As these techniques are not used in the UK, we propose that a prospective development study (IDEAL stage 2a) is necessary prior to a multi-centre effectiveness trial.
0018: INTRA-OPERATIVE HYPERSPECTRAL IMAGING FOR BRAIN TUMOUR DETECTION AND DELINEATION: CURRENT PROGRESS ON THE HELICOID PROJECT S. Kabwama 1, *, D. Bulters 1, H. Bulstrode 1, H. Fabelo 2, S. Ortega 2, G.M. Callico 2, B. Stanciulescu 4, R. Kiran 4, D. Ravi 3, A. Szolna 5, ~ eiro 1,2, 3, 4,5. 1 Wessex Neurological Centre, University Hospital J.F. Pin Southampton, Southampton, UK; 2 University of Las Palmas de Gran Canaria Institute for Applied Microelectronics, Las Palmas de Gran Canaria, Spain; 3 Imperial College London, London, UK; 4 ARMINES, Paris, France; 5 University Hospital Doctor Negrín, Las Palmas de Gran Canaria, Spain. Background: Hyperspectral Imaging (HSI) captures spectral information that has been shown to characterise tissues. Since the surgeon's naked eye is sometimes unable to differentiate between tumour and normal brain, HSI could be a solution. Aims: We aim to develop an intra-operative HSI system capable of tumour detection and delineation. Methods: Using a newly developed HSI system that captures images across the visible and near-infrared electromagnetic spectrum (from 400nm to 1700nm); we obtained hyperspectral images during tumour resection. Before imaging, markers were placed at the location of the tumour and normal brain. Images were then captured with the markers insitu. Tissue samples were obtained from the location of the markers and sent for tissue diagnosis. A pre-processing chain was then applied to the spectrum of each pixel within the hyperspectral images. The spectra and pixels within the areas marked areas were then labelled with their tissue diagnosis. This labelled data was then used to produce and test algorithms that automatically classified images from their spectral signatures. Results: Using data from 22 resections, we have developed algorithms capable of automatically identifying tumour and normal brain from hyperspectral images. Furthermore, the algorithms were capable of producing a 2D colour map correlating to the location of the tumour and normal brain. Conclusion: The HELICoid project has made excellent progress and current results are very promising. However, more images are needed in order for us to produce a validated HSI system capable of providing real time intra-operative information on tumour type, grade and location.
0021: DEVELOPING A PATIENT AND PUBLIC INVOLVEMENT INTERVENTION TO ENHANCE RECRUITMENT AND RETENTION IN UK SURGICAL TRIALS (PIRRIST) J.C. Crocker 1,2, *, S. Rees 1, L. Locock 2, 3, S. Petit-Zeman 4, A. Chant 5, S. Treweek 6, J.A. Cook 7,8, N. Farrar 2, 7, K. Woolfall 9, J. Bostock 10, L. Bowman 11, R. Bulbulia 11,12. 1 Health Experiences Institute, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; 2 NIHR Oxford Biomedical Research Centre, Oxford, UK; 3 Health Experiences Research Group, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; 4 NIHR Oxford Biomedical Research Centre and Unit, Oxford, UK; 5 Patient Partner, Berkshire, UK; 6 Health Services Research Unit, University of Aberdeen, Aberdeen, UK; 7 Surgical Intervention Trials Unit, University of Oxford, Oxford, UK; 8 MRC ConDuCT-II Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, UK; 9 MRC North West Hub for Trials Methodology Research, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK; 10 Lay Partner, London, UK; 11 MRC CTSU Hub for Trials Methodology Research, Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; 12 Cheltenham General Hospital, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK. Background and aims: Poor recruitment and retention are common challenges to the successful delivery of surgical trials, possibly alleviated by greater patient and public involvement (PPI). We aim to develop a
Abstracts / International Journal of Surgery 36 (2016) S138eS143
areas could inform future authors and improve the specialty's evidence base.
0008: THE USE OF STUDY REGISTRATION AND PROTOCOLS IN PLASTIC SURGERY RESEARCH: A SYSTEMATIC REVIEW T.E. Pidgeon 1, 7, *, C. Limb 2, 7, R. Agha 3,7, K. Whitehurst 4,7, C. Chandrakumar 5, 7, G. Wellstead 5, 7, A.J. Fowler 3, 7, D. Orgill 6. 1 St. Andrew's Centre for Plastic Surgery and Burns, Essex, UK; 2 Royal Sussex County Hospital, Brighton and Sussex NHS Trust, Brighton, UK; 3 Guy's and St. Thomas' NHS Foundation Trust, London, UK; 4 University College London Medical School, London, UK; 5 Barts and the London School of Medicine and Dentistry, London, UK; 6 Division of Plastic Surgery, Brigham and Women's Hospital, Boston, USA; 7 The Academic Surgical Collaborative, UK. Background: In 2013, the Declaration of Helsinki mandated that every research study involving human subjects must have its protocol registered in a publicly accessible database prior to the enrolment of the first patient. This systematic review assessed the number of studies published in leading journals of plastic surgery that had either published or registered a protocol with a publicly accessible database. Material and methods: All research articles involving human participants published in Plastic and Reconstructive Surgery, The Journal of Plastic Reconstructive and Aesthetic Surgery and The Annals of Plastic Surgery from 1st April 2014 - 31st March 2015 were examined. The primary outcome measure was whether each study had registered or published a protocol with any mainstream registry database. ClinicalTrials.gov, International Standard Randomised Control Trial Number (ISRCTN), WHO (World Health Organization) International Clinical Trials Registry Platform, The Cochrane Collaboration, the Research Registry, PROSPERO and PubMed were all reviewed. Preliminary results Of 595 included articles, the most common study designs were case series (n¼185, 31.1%). There were 24 randomised controlled trials (RCTs, 4.0%). A total of 24 studies had a protocol registered (4.0%), although no studies had published a protocol in a journal. The most common database to register a protocol was ClinicalTrials.gov (n¼17). The study design that most commonly had a registered protocol was the RCT (n¼8 of 24, 33.3% of RCTs). Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low. There is considerable scope to improve this and relevant guidance is provided.
0011: TWIST-DRILL CRANIOSTOMY WITH HOLLOW SCREWS FOR EVACUATION OF CHRONIC SUBDURAL HAEMATOMA A.G. Kolias 1, 2, *, A. Chari 1, S.J. Bond 2, 3, P.J.A. Hutchinson 1, 2. 1 Division of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK; 2 Cambridge Clinical Trials Unit, Cambridge, UK; 3 MRC Biostatistics Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Objectives: The incidence of chronic subdural haematoma (CSDH) is expected to increase substantially over the next 25 years. Continuing refinement of techniques for surgical evacuation is essential. A novel technique involving a hollow screw, which is threaded through a twistdrill hole in the cranium and then connected to a closed drainage system, has been increasing in popularity. The aim of this systematic review is to collate and analyse available published data. Methods: MEDLINE, Web of Knowledge, EMBASE, and the Cochrane Database were searched for published series involving more than 10 patients. Results: Nine eligible studies were found (6 case series and 3 case-control studies) comprising 796 patients. Seven used the SEPS system (commercially available and manufactured by Medtronic Inc) and 2 studies used the hollow screw (manufactured by Teleflex Medical). The procedures are similar, but the hollow screw procedure uses intra-operative and post-operative (once daily) irrigation routinely to promote brain re-expansion. The SEPS does not use irrigation but relies on a low negative pressure applied through a suction reservoir bulb to promote drainage of the collection and gradual brain reexpansion. Pooled analysis showed a 'success rate' of 77.6% (95% CI 74.6%e 80.4%), recurrence rate of 22.4%, and in-hospital mortality of 1.4%.
Conclusions: On the basis of the available evidence, we believe that this new technique should be systematically assessed according to the IDEAL framework. As these techniques are not used in the UK, we propose that a prospective development study (IDEAL stage 2a) is necessary prior to a multi-centre effectiveness trial.
0018: INTRA-OPERATIVE HYPERSPECTRAL IMAGING FOR BRAIN TUMOUR DETECTION AND DELINEATION: CURRENT PROGRESS ON THE HELICOID PROJECT S. Kabwama 1, *, D. Bulters 1, H. Bulstrode 1, H. Fabelo 2, S. Ortega 2, G.M. Callico 2, B. Stanciulescu 4, R. Kiran 4, D. Ravi 3, A. Szolna 5, ~ eiro 1,2, 3, 4,5. 1 Wessex Neurological Centre, University Hospital J.F. Pin Southampton, Southampton, UK; 2 University of Las Palmas de Gran Canaria Institute for Applied Microelectronics, Las Palmas de Gran Canaria, Spain; 3 Imperial College London, London, UK; 4 ARMINES, Paris, France; 5 University Hospital Doctor Negrín, Las Palmas de Gran Canaria, Spain. Background: Hyperspectral Imaging (HSI) captures spectral information that has been shown to characterise tissues. Since the surgeon's naked eye is sometimes unable to differentiate between tumour and normal brain, HSI could be a solution. Aims: We aim to develop an intra-operative HSI system capable of tumour detection and delineation. Methods: Using a newly developed HSI system that captures images across the visible and near-infrared electromagnetic spectrum (from 400nm to 1700nm); we obtained hyperspectral images during tumour resection. Before imaging, markers were placed at the location of the tumour and normal brain. Images were then captured with the markers insitu. Tissue samples were obtained from the location of the markers and sent for tissue diagnosis. A pre-processing chain was then applied to the spectrum of each pixel within the hyperspectral images. The spectra and pixels within the areas marked areas were then labelled with their tissue diagnosis. This labelled data was then used to produce and test algorithms that automatically classified images from their spectral signatures. Results: Using data from 22 resections, we have developed algorithms capable of automatically identifying tumour and normal brain from hyperspectral images. Furthermore, the algorithms were capable of producing a 2D colour map correlating to the location of the tumour and normal brain. Conclusion: The HELICoid project has made excellent progress and current results are very promising. However, more images are needed in order for us to produce a validated HSI system capable of providing real time intra-operative information on tumour type, grade and location.
0021: DEVELOPING A PATIENT AND PUBLIC INVOLVEMENT INTERVENTION TO ENHANCE RECRUITMENT AND RETENTION IN UK SURGICAL TRIALS (PIRRIST) J.C. Crocker 1,2, *, S. Rees 1, L. Locock 2, 3, S. Petit-Zeman 4, A. Chant 5, S. Treweek 6, J.A. Cook 7,8, N. Farrar 2, 7, K. Woolfall 9, J. Bostock 10, L. Bowman 11, R. Bulbulia 11,12. 1 Health Experiences Institute, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; 2 NIHR Oxford Biomedical Research Centre, Oxford, UK; 3 Health Experiences Research Group, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; 4 NIHR Oxford Biomedical Research Centre and Unit, Oxford, UK; 5 Patient Partner, Berkshire, UK; 6 Health Services Research Unit, University of Aberdeen, Aberdeen, UK; 7 Surgical Intervention Trials Unit, University of Oxford, Oxford, UK; 8 MRC ConDuCT-II Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, UK; 9 MRC North West Hub for Trials Methodology Research, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK; 10 Lay Partner, London, UK; 11 MRC CTSU Hub for Trials Methodology Research, Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; 12 Cheltenham General Hospital, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK. Background and aims: Poor recruitment and retention are common challenges to the successful delivery of surgical trials, possibly alleviated by greater patient and public involvement (PPI). We aim to develop a