What this study adds
gallstone, Karlygash, Wilson
MOORE, GALLSTONE, RECRUITMENT, DAWSON, WELLS, BROWN
In the short term (<18 months), conservative management, as an alternative to surgery, may be effective and cost effective in patients with uncomplicated symptomatic gallstone diseaseCosts and benefits will continue to be incurred in both trial groups beyond 24 monthsFuture research is needed to collect long term follow-up data to establish lifetime cost effectiveness and to identify those patients who will benefit from surgeryThis project will be published in full in the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme series. Data monitoring committee: Catherine Hewitt (University of York), Jonathan Lund (University of Nottingham), Tim McAdam (Belfast Health and Social Care Trust), and Amir Nisar (Maidstone and Tunbridge Wells NHS Trust). Trial steering group: David Beard (University of Oxford), Ian Beckingham (Nottingham University Hospitals NHS Trust), John Leeds (Newcastle Hospitals NHS Foundation Trust), and Dee McDonald (patient representative).
Principal investigators (PIs) and research teams: James Milburn (PI), Irfan Ahmed (PI), Momin Malik, Sandra Mann, Amy Nicol (nee Angus), Tracy Scott, Lorna Van Lierop (Aberdeen Royal Infirmary); Dipankar Chattopadhyay (PI), Beena David, Carina Galpin, Mel Penacerrada, Kanapathi Rajaratnam, Retno Walandari (Bedford Hospital NHS Trust); Robert Sutcliffe (PI), Elizabeth Cornes, Sharon Garner, Manijeh Ghods, Ewen Griffiths, Ravi Marudanayagam, Andrew McDarby, Claire McNeill, Sonia Puig-Compano, Keith Roberts, Arlo Whitehouse (Birmingham Heartlands Hospital); Jamie Young (PI), Joy Dawson, Dave Gribble, Laura Stephen (Borders General Hospital); David O'Reilly (PI), Rezwana Chowdhury, Antonio Foliaki, Martin Grigg, Laura Jones, Lucy Knibbs, Gail Williams, Jolene Witherspoon, Caroline Young (University Hospital of Wales, Cardiff); Jawad Ahmad (PI), Susan Dale, Natalie Kenny, Edward Lopez, Gabriele Marangoni (Coventry University Hospital); Zaher Toumi (PI), Sarah Clark, Louise Duncan, Stef Hobson, Andrea Kay, Ami Laidlaw, Diana Nayman, Ami Wilkinson (University Hospital North Durham); Peter Driscoll (PI), Karlygash Ausel, Laura Beveridge, Keith Boath, Geert Koffeman, Sue Pick (Victoria Hospital, Fife); Simon Gibson (PI), Anissa Benchiheub, Carol Dalton, Paul Glen, Steven Henderson, Gillian Rice (Queen Elizabeth University Hospital, Glasgow); Markos Daskalakis (PI), Sally Abbott, Safia Begum, Maryam Hussain, Tabinda Kharodia, Julie Markley, Faye Moore, Raj Nijjar, VJ Shabangu, Karim Sillah, Rishi Singhal, Samantha Stafford, Paul Super, Olga Tucker (Birmingham Heartlands Hospital); Christopher Halloran (PI), Lorna Fleming-Bird, Julie Haydock, Francesca Westwell (Royal Liverpool University Hospital); Andrew Beamish (PI), Michael Nutt (PI), Ashraf Rasheed (PI), Lindianne Aitken, Evelyn Baker, Nancy Hawkings, Georgia Mallison, Heeam Nassa, Grace Okoro, Claire Price, Sandapa Punchihewa, Laura Smith, Jemma Tuffney, Elaine Wall, Cerian Williams (Royal Gwent Hospital, Newport); Talvinder Gill (PI), Mazuin Abutalib, Ish Ahmed, Rajendirin Ashwin, Liz Baker, Leo Brown, Bussa Gopinath, Deena Harji, Siddek Isreb, Aya Musbahi, Milind Rao, Murugappan Shanmugam, Kyaw Toe, Suvi Virupaksha, Debbie Wilson (North Tees University Hospital); Ravinder Vohra (PI), Tracy Brear, Debra Campion, Jody Carvell, James Catton, David Chadwick, Sam Dutta, Tanvir Hossain, Maria Laye, Kate Marks, Simon Parsons, Shirley Pyke, Judith Rozentals, John Saunders, Nilanjana Tewari, Rhian Warman, Neil Welch, Fady Yanni (Nottingham City Hospital); David Stell (PI), Abigail Patrick, Aleasha Udal, Natasha Wilmshurst (Plymouth Hospitals NHS Trust); Brian Davidson (PI), Christine Eastgate, Helder Filipe, Yvonne Gleeson, Kurinchi Gurusamy (Royal Free Hospital, London); Andrew Torrance (PI), Veronica Campbell, Julie Colley, Mokhtar Eltair, Samia Hussain, Yogesh Kumar, Rajnish Mankotia, Jenny Porter, Liam Preece, Elizabeth Williams (Sandwell Medical Research Unit); Marianne Hollyman (PI), Sarah Brown, Katrina Butcher, Viktoria Cripps, Rebecca Goodchild, Libby Graham, Ami Mackay, Matthew Mason, Peter Mekhail, Alison Moss, Hamish Noble, Maria O'Leary, Corinne Pawley, Andrew Robertson, Charmaine Shovelton, Muwaffaq Telfah, Frances Venn, Richard Welbourn, Esther Zebracki (Musgrove Park Hospital, Taunton); Paul Marriott (PI), Indy Atwal, Bridget Campbell, Vasileios Charalampakis, Angela Day, Angela Doyle, Sophie Mason, Penny Parsons, Alexandra Smith, Karen Spicer, Frances Walsh, Kathryn Webb (Warwick Hospital); John Spearman (PI), Joanna Allison, Kate Beesley, Nathan Curtis, Godwin Dennison, Linda Howard, Alison Lewis, Jess Perry (Yeovil District Hospital).Extra material supplied by authorsSupplementary information: Appendices 1 and 2Contributors: IA, RH, KG, AA, MB, BC, PM, SW, and CR conceived the trial. IA, KI, RH, KG, AA, BC, JB, PM, CR designed the trial. IA was involved in recruitment and was responsible for the day-to-day oversight of the trial. KI, RB, VB, and CR were responsible for the day-to-day management of the trial. JH conducted the statistical analysis. RH conducted the health economics analysis. SC contributed to oversight of the day-to-day management of the trial. BC was responsible for the conduct of the trial, recruitment, and follow-up of participants, and focused on the patient and public involvement components of the trial. MF contributed to the design of the trial software and data curation. GM contributed to the statistical analysis. IA, KI, JH, RH, KG, RB, VB, AA, JB, MB, SC, BC, MF, GM, PM, SW, and CR contributed to the interpretation of findings and the reporting of the study. All authors have critically reviewed and approved the final manuscript version. The corresponding author had full access to all the data in the trial and had final responsibility for the decision to submit for publication. IA and CR act as guarantors. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme (project No 14/192/71). The Health Services Research Unit of the University of Aberdeen is funded in part by the chief scientist’s office of the Scottish government’s health and social care directorates. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the chief scientist’s office, HTA programme, NIHR, NHS, or Department of Health. The funder had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Competing interests: All authors have completed the ICMJE uniform disclosure form at The study guarantors (IA and CR) affirm that the manuscript is an honest, accurate, and transparent account of the study being reported, that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.Dissemination to participants and related patient and public communities: In collaboration with our patient and public involvement partners and patient and public involvement group, we plan to develop dissemination materials (including an infographic) for participants. We will prepare a plain-language summary for the C-GALL website. We will share our findings with relevant charity and support groups, including gutsuk! (Provenance and peer review: Commissioned; not externally peer reviewed.