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3. An observational analysis of a novel digital rectoscope

Author

Maria Souvatzi, Jonathan M Wilson, Louis J Vitone, James A Lewis, Shabuddin Khan, Baljit Singh, Henry S Tilney, and James Kinross

Subjects
Adult, Male, Telemedicine, medicine.medical_specialty, Technology Assessment, Biomedical, Colorectal cancer, Biopsy, Observational analysis, MEDLINE, Video Recording, Medicine, Humans, Medical physics, Medical diagnosis, Adverse effect, Watchful Waiting, Sigmoidoscopy, Aged, medicine.diagnostic_test, business.industry, Rectal Neoplasms, Anastomosis, Surgical, Gastroenterology, Rectum, 1103 Clinical Sciences, General Medicine, Middle Aged, medicine.disease, Colitis, Clinical diagnosis, Preceptorship, Female, Surgery, business
Abstract

Background This is an analysis of the first 50 in-human uses of a novel digital rigid sigmoidoscope. The technology provides digital image capture, telemedicine capabilities, improved ergonomics, and the ability to biopsy under pneumorectum while maintaining the low cost of conventional rigid sigmoidoscopy. The primary outcome was adverse events, and the secondary outcome was diagnostic view. Preliminary results Fifty patients underwent outpatient (n = 25) and surgical rectal assessment (n = 25), with a mean age of 60 years. This included 31 men and 19 women with 12 different clinical use indications. No adverse events were reported, and no defects were reported with the instrumentation. Satisfactory diagnoses were obtained in 48 (96%) of 50 uses, images were captured in 48 (96%) of 50 uses, and biopsies were successfully taken in 13 uses (26%). No adverse events were recorded. Independent reviewers of recorded videos agreed on the quality and diagnostic value of the images with a κ of 0.225 (95% CI, 0.144-0.305) when assessing whether the target pathology was adequately visualized. Impact of innovation The improved views afforded by digital rectoscopy facilitated a satisfactory clinical diagnosis in 96% of uses. The device was successfully deployed in the operating room and outpatients irrespective of bowel preparation method, where it has the potential to replace flexible sigmoidoscopy for specific use cases. The technology provides a high-quality image and video that can be securely recorded for documentation and medicolegal purposes with agreement between blinded users despite a lack of standardized training and heterogenous pathology. We perceive significant impact of this technology for the assessment of colorectal anastomoses, the office management of colitis, "watch and wait," and for diagnostic support in rectal cancer diagnosis. The technology has significant potential to facilitate proctoring and training, and it now requires prospective trials to validate its diagnostic accuracy against more costly flexible sigmoidoscopy systems.

Published
2021

4. Preoperative risk factors for conversion from laparoscopic to open cholecystectomy: a validated risk score derived from a prospective U.K. database of 8820 patients

Author

Robert P. Sutcliffe, Marianne Hollyman, James Hodson, Glenn Bonney, Ravi S. Vohra, Ewen A. Griffiths, Stephen Fenwick, Mohamed Elmasry, Quentin Nunes, David Kennedy, Raja B. Khan, Muhammad A.S. Khan, Conor J. Magee, Steven M. Jones, Denise Mason, Ciny P. Parappally, Pawan Mathur, Michael Saunders, Sara Jamel, Samer U.l. Haque, Sara Zafar, Muhammad H. Shiwani, Nehemiah Samuel, Farooq Dar, Andrew Jackson, Bryony Lovett, Shiva Dindyal, Hannah Winter, Saquib Rahman, Kevin Wheatley, Tom Nieto, Soofiyah Ayaani, Haney Youssef, Rajwinder S. Nijjar, Helen Watkin, David Naumann, Sophie Emeshi, Piyush B. Sarmah, Kathryn Lee, Nikita Joji, Jonathan Heath, Rebecca L. Teasdale, Chamindri Weerasinghe, Paul J. Needham, Hannah Welbourn, Luke Forster, David Finch, Jane M. Blazeby, William Robb, Angus G.K. McNair, Alex Hrycaiczuk, Alexandros Charalabopoulos, Sritharan Kadirkamanathan, Cheuk-Bong Tang, Naga V.G. Jayanthi, Nigel Noor, Brian Dobbins, Andrew J. Cockbain, April Nilsen-Nunn, Jonathan de Siqueira, Mike Pellen, Jonathan B. Cowley, Wei-Min Ho, Victor Miu, Timothy J. White, Kathryn A. Hodgkins, Alison Kinghorn, Matthew G. Tutton, Yahya A. Al-Abed, Donald Menzies, Anwar Ahmad, Joanna Reed, Shabuddin Khan, David Monk, Louis J. Vitone, Ghulam Murtaza, Abraham Joel, Stephen Brennan, David Shier, Catherine Zhang, Thusidaran Yoganathan, Steven J. Robinson, Iain J.D. McCallum, Michael J. Jones, Mohammed Elsayed, Liz Tuck, John Wayman, Kate Carney, Somaiah Aroori, Kenneth B. Hosie, Adam Kimble, David M. Bunting, Adeshina S. Fawole, Mohammed Basheer, Rajiv V. Dave, Janahan Sarveswaran, Elinor Jones, Chris Kendal, Michael P. Tilston, Martin Gough, Tom Wallace, Shailendra Singh, Justine Downing, Katherine A. Mockford, Eyad Issa, Nayab Shah, Neal Chauhan, Timothy R. Wilson, Amir Forouzanfar, Jonathan R.L. Wild, Emma Nofal, Catherine Bunnell, Khaliel Madbak, Sudhindra T.V. Rao, Laurence Devoto, Najaf Siddiqi, Zechan Khawaja, James C. Hewes, Laura Gould, Alice Chambers, Daniel U. Rodriguez, Gourab Sen, Stuart Robinson, Francis Bartlett, David M. Rae, Thomas E.J. Stevenson, Kas Sarvananthan, Simon J. Dwerryhouse, Simon M. Higgs, Oliver J. Old, Thomas J. Hardy, Reena Shah, Steve T. Hornby, Ken Keogh, Lucinda Frank, Musallam Al-Akash, Emma A. Upchurch, Richard J. Frame, Michael Hughes, Clare Jelley, Simon Weaver, Sudipta Roy, Toritseju O. Sillo, Giorgios Galanopoulos, Tamzin Cuming, Pedro Cunha, Salim Tayeh, Sarantos Kaptanis, Mohamed Heshaishi, Abdalla Eisawi, Michael Abayomi, Wee S. Ngu, Katie Fleming, Dalvir S. Bajwa, Vivek Chitre, Kamal Aryal, Paul Ferris, Michael Silva, Simon Lammy, Sarah Mohamed, Amir Khawaja, Adnan Hussain, Mudassar A. Ghazanfar, Maria I. Bellini, Hamdi Ebdewi, Mohamed Elshaer, Gianpiero Gravante, Benjamin Drake, Arikoge Ogedegbe, Dipankar Mukherjee, Chanpreet Arhi, Lola Giwa, Nusrat Iqbal, Nicholas F. Watson, Smeer K. Aggarwal, Philippa Orchard, Eduardo Villatoro, Peter D. Willson, Kam W.J. Mok, Thomas Woodman, Jean Deguara, Giuseppe Garcea, Benoy I. Babu, Alistair R. Dennison, Deep Malde, David Lloyd, John P. Slavin, Robert P. Jones, Laura Ballance, Stratos Gerakopoulos, Periyathambi Jambulingam, Sami Mansour, Naomi Sakai, Vikas Acharya, Mohammed M. Sadat, Lawen Karim, David Larkin, Khalid Amin, Amarah Khan, Jennifer Law, Saurabh Jamdar, Stella R. Smith, Keerthika Sampat, Kathryn M. O'shea, Mangta Manu, Fotini M. Asprou, Nabeela S. Malik, Jessica Chang, Marianne Johnstone, Michael Lewis, Geoffrey P. Roberts, Babu Karavadra, Evangelos Photi, James Hewes, Dan Rodriguez, Derek A. O'Reilly, Anthony J. Rate, Hema Sekhar, Lucy T. Henderson, Benjamin Z. Starmer, Peter O. Coe, Sotonye Tolofari, Jenifer Barrie, Gareth Bashir, Jake Sloane, Suroosh Madanipour, Constantine Halkias, Alexander E.J. Trevatt, David W. Borowski, Jane Hornsby, Michael J. Courtney, Suvi Virupaksha, Keith Seymour, Sarah Robinson, Helen Hawkins, Sadiq Bawa, Paul V. Gallagher, Alistair Reid, Peter Wood, Jonathan G. Finch, J.Guy Finch, Jitesh Parmar, Euan Stirland, James Gardner-Thorpe, Ahmed Al-Muhktar, Mark Peterson, Ali Majeed, Farrukh M. Bajwa, Jack Martin, Alfred Choy, Andrew Tsang, Naresh Pore, David R. Andrew, Waleed Al-Khyatt, Christopher Taylor Santosh Bhandari, Adam Chambers, Dhivya Subramanium, Simon K.C. Toh, Nicholas C. Carter, Stuart J. Mercer, Benjamin Knight, Vardhini Vijay, Swethan Alagaratnam, Sidhartha Sinha, Shahab Khan, Shamsi S. El-Hasani, Abdulzahra A. Hussain, Vish Bhattacharya, Nisheeth Kansal, Tani Fasih, Claire Jackson, Midhat N. Siddiqui, Imran A. Chishti, Imogen J. Fordham, Zohaib Siddiqui, Harald Bausbacher, Ileana Geogloma, Kabita Gurung, George Tsavellas, Pradeep Basynat, Ashish K. Shrestha, Sanjoy Basu, Alok Chhabra, Mohan Harilingam, Mohamed Rabie, Mansoor Akhtar, Pradeep Kumar, Sadaf F. Jafferbhoy, Najam Hussain, Soulat Raza, Manzarul Haque, Imran Alam, Rabiya Aseem, Shakira Patel, Mehek Asad, Michael I. Booth, William R. Ball, Christopher P.J. Wood, Ana C. Pinho-Gomes, Ambareen Kausar, Mohammed Obeidallah, Joseph Varghase, Joshil Lodhia, Donal Bradley, Carla Rengifo, David Lindsay, Sivakumar Gopalswamy, Ian Finlay, Stacy Wardle, Naomi Bullen, Syed Y. Iftikhar, Altaf Awan, Javed Ahmed, Paul Leeder, Guiseppe Fusai, Giles Bond-Smith, Alicja Psica, Yogesh Puri, David Hou, Fergus Noble, Karoly Szentpali, Jack Broadhurst, Ravindra Date, Martin R. Hossack, Yan L. Goh, Paul Turner, Vinutha Shetty, Manel Riera, Christina A.W. Macano, Anisha Sukha, Shaun R. Preston, Jennifer R. Hoban, Daniel J. Puntis, Sophie V. Williams, Richard Krysztopik, James Kynaston, Jeremy Batt, Matthew Doe, Andrzej Goscimski, Gareth H. Jones, Claire Hall, Nick Carty, Jamil Ahmed, Sofoklis Panteleimonitis, Rohan T. Gunasekera, Andrea R.G. Sheel, Hannah Lennon, Caroline Hindley, Marcus Reddy, Ross Kenny, Natalie Elkheir, Emma R. McGlone, Rajasundaram Rajaganeshan, Kate Hancorn, Anita Hargreaves, Raj Prasad, David A. Longbotham, Dhakshinamoorthy Vijayanand, Imeshi Wijetunga, Paul Ziprin, Christopher R. Nicolay, Geoffrey Yeldham, Edward Read, James A. Gossage, Rachel C. Rolph, Husam Ebied, Manraj Phull, Mohammad A. Khan, Matthew Popplewell, Dimitrios Kyriakidis, Anwar Hussain, Natasha Henley, Jessica R. Packer, Laura Derbyshire, Jonathan Porter, Shaun Appleton, Marwan Farouk, Melvinder Basra, Neil A. Jennings, Shahda Ali, Venkatesh Kanakala, Haythem Ali, Risha Lane, Richard Dickson-Lowe, Prizzi Zarsadias, Darius Mirza, Sonia Puig, Khalid Al Amari, Deepak Vijayan, Robert Sutcliffe, Ravi Marudanayagam, Zayed Hamady, Abheesh R. Prasad, Abhilasha Patel, Damien Durkin, Parminder Kaur, Laura Bowen, James P. Byrne, Katherine L. Pearson, Theo G. Delisle, James Davies, Mark A. Tomlinson, Michelle A. Johnpulle, Corinna Slawinski, Andrew Macdonald, James Nicholson, Katy Newton, James Mbuvi, Ansar Farooq, Bhavani S. Mothe, Zakhi Zafrani, Daniel Brett, James Francombe, Philip Spreadborough, James Barnes, Melanie Cheung, Ahmed Z. Al-Bahrani, Giuseppe Preziosi, Tomas Urbonas, Justin Alberts, Mekhlola Mallik, Krashna Patel, Ashvina Segaran, Triantafyllos Doulias, Pratik A. Sufi, Caroline Yao, Sarah Pollock, Antonio Manzelli, Saj Wajed, Michail Kourkulos, Roberto Pezzuto, Martin Wadley, Emma Hamilton, Shameen Jaunoo, Robert Padwick, Mazin Sayegh, Richard C. Newton, Madhusoodhana Hebbar, Sameh F. Farag, Madhu Hebbar, John Spearman, Mohammed F. Hamdan, Conrad D'Costa, Christine Blane, Mathew Giles, Mark B. Peter, Natalie A. Hirst, Tanvir Hossain, Arslan Pannu, Yesar El-Dhuwaib, Tamsin E.M. Morrison, Greg W. Taylor, Ronald L.E. Thompson, Ken McCune, Paula Loughlin, Roger Lawther, Colman K. Byrnes, Duncan J. Simpson, Abi Mawhinney, Conor Warren, Damian McKay, Colin McIlmunn, Serena Martin, Matthew MacArtney, Tom Diamond, Phil Davey, Claire Jones, Joshua M. Clements, Ruairi Digney, Wei M. Chan, Stephen McCain, Sadaf Gull, Adam Janeczko, Emmet Dorrian, Andrew Harris, Suzanne Dawson, Dorothy Johnston, Barry McAree, Essam Ghareeb, George Thomas, Martin Connelly, Stephen McKenzie, Krzysztos Cieplucha, Gary Spence, William Campbell, Gareth Hooks, Neil Bradley, Arnold D.K. Hill, John T. Cassidy, Michael Boland, Paul Burke, Deirdre M. Nally, Elmoataz Khogali, Wael Shabo, Edrin Iskandar, Gerry P. McEntee, Maeve A. O'Neill, Colin Peirce, Emma M. Lyons, Adrian W. O'Sullivan, Rohan Thakkar, Paul Carroll, Ivan Ivanovski, Paul Balfe, Matthew Lee, Des C. Winter, Michael E. Kelly, Emir Hoti, Donal Maguire, Priyadarssini Karunakaran, Justin G. Geoghegan, Sean T. Martin, Keith S. Cross, Fiachra Cooke, Saquib Zeeshan, James O. Murphy, Ken Mealy, Helen M. Mohan, Yuwaraja Nedujchelyn, Muhammad F. Ullah, Irfan Ahmed, Francesco Giovinazzo, James Milburn, Sarah Prince, Eleanor Brooke, Joanna Buchan, Ahmed M. Khalil, Elizabeth M. Vaughan, Michael I. Ramage, Roland C. Aldridge, Simon Gibson, Gary A. Nicholson, David G. Vass, Alan J. Grant, David J. Holroyd, Angharad Jones, Cherith M.L.R. Sutton, Patrick O'Dwyer, Frida Nilsson, Beatrix Weber, Tracey K. Williamson, Kushik Lalla, Alice Bryant, Ross Carter, Craig R. Forrest, David I. Hunter, Ahmad H. Nassar, Mavis N. Orizu, Katrina Knight, Haitham Qandeel, Stuart Suttie, Rowena Belding, Andrew McClarey, Alan T. Boyd, Graeme J.K. Guthrie, Pei J. Lim, Andreas Luhmann, Angus J.M. Watson, Colin H. Richards, Laura Nicol, Marta Madurska, Ewen Harrison, Kathryn M. Boyce, Amanda Roebuck, Graeme Ferguson, Pradeep Pati, Michael S.J. Wilson, Faith Dalgaty, Laura Fothergill, Peter J. Driscoll, Kirsty L. Mozolowski, Victoria Banwell, Stephen P. Bennett, Paul N. Rogers, Brendan L. Skelly, Claire L. Rutherford, Ahmed K. Mirza, Taha Lazim, Henry C.C. Lim, Diana Duke, Talat Ahmed, William D. Beasley, Marc D. Wilkinson, Geta Maharaj, Cathy Malcolm, Timothy H. Brown, Guy M. Shingler, Nicholas Mowbray, Rami Radwan, Paul Morcous, Simon Wood, Abbas Kadhim, Duncan J. Stewart, Andrew L. Baker, Nicola Tanner, and Hrishikesh Shenoy

Subjects
Male, Databases, Factual, medicine.medical_treatment, 0302 clinical medicine, Risk Factors, Odds Ratio, Prospective Studies, Prospective cohort study, Framingham Risk Score, Gastroenterology, Age Factors, Gallbladder, Middle Aged, Conversion to Open Surgery, Treatment Outcome, Cholecystectomy, Laparoscopic, 030220 oncology & carcinogenesis, Predictive value of tests, 030211 gastroenterology & hepatology, Female, Original Article, Risk assessment, Dilatation, Pathologic, Adult, medicine.medical_specialty, Digestive System Diseases, MEDLINE, Risk Assessment, 03 medical and health sciences, Sex Factors, Predictive Value of Tests, medicine, Humans, Aged, Common Bile Duct, Chi-Square Distribution, Hepatology, Laparoscopyc cholecystectomy, business.industry, General surgery, Reproducibility of Results, Odds ratio, United Kingdom, Surgery, preoperative assessment, Logistic Models, Multivariate Analysis, Cholecystectomy, business, Chi-squared distribution, risk factors
Abstract

Laparoscopic cholecystectomy is commonly performed, and several factors increase the risk of open conversion, prolonging operating time and hospital stay. Preoperative stratification would improve consent, scheduling and identify appropriate training cases. The aim of this study was to develop a validated risk score for conversion for use in clinical practice.Preoperative patient and disease-related variables were identified from a prospective cholecystectomy database (CholeS) of 8820 patients, divided into main and validation sets. Preoperative predictors of conversion were identified by multivariable binary logistic regression. A risk score was developed and validated using a forward stepwise approach.Some 297 procedures (3.4%) were converted. The risk score was derived from six significant predictors: age (p = 0.005), sex (p 0.001), indication for surgery (p 0.001), ASA (p 0.001), thick-walled gallbladder (p = 0.040) and CBD diameter (p = 0.004). Testing the score on the validation set yielded an AUROC = 0.766 (p 0.001), and a score6 identified patients at high risk of conversion (7.1% vs. 1.2%).This validated risk score allows preoperative identification of patients at six-fold increased risk of conversion to open cholecystectomy.

Published
2016

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