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Library›Open textbooks›Laparoscopic cholecystectomy versus conservative management for adults with uncomplicated symptomatic gallstones: the C-GALL RCT›References

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Laparoscopic cholecystectomy versus conservative management for adults with uncomplicated symptomatic gallstones: the C-GALL RCT · References

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CC BY 4.0 · National Institute for Health and Care Research · approximately 15 min read

  1. Ahmed I, Innes K, Brazzelli M, Gillies K, Newlands R, Avenell A, et al. Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial). BMJ Open 2021;11(3):e039781.
  2. American College of Physicians. Guidelines for the treatment of gallstones. Ann Intern Med 1993;119(7 Pt. 1):620–2.8204129
  3. Portincasa P, Moschetta A, Palasciano G. Cholesterol gallstone disease. Lancet 2006;368(9531):230–9.16844493
  4. Shaffer EA. Gallstone disease: epidemiology of gallbladder stone disease. Best Pract Res Clin Gastroenterol 2006;20(6):981–96.17127183
  5. Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin North Am 2010;39(2):157–69, vii.20478480
  6. Bateson MC. Gallstones and cholecystectomy in modern Britain. Postgrad Med J 2000;76(901):700–3.11060144
  7. Barbara L, Sama C, Morselli Labate AM, Taroni F, Rusticali AG, Festi D, et al. A population study on the prevalence of gallstone disease: the Sirmione study. Hepatology 1987;7(5):913–7.3653855
  8. Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic differences in gallbladder disease in the United States. Gastroenterology 1999;117(3):632–9.10464139
  9. Heaton KW, Braddon FE, Mountford RA, Hughes AO, Emmett PM. Symptomatic and silent gall stones in the community. Gut 1991;32(3):316–20.2013429
  10. Williams JG, Roberts SE, Ali MF, Cheung WY, Cohen DR, Demery G, et al. Gastroenterology services in the UK: the burden of disease, and the organisation and delivery of services for gastrointestinal and liver disorders: a review of the evidence. Gut 2007;56(Suppl. 1):1–113.
  11. Festi D, Dormi A, Capodicasa S, Staniscia T, Attili AF, Loria P, et al. Incidence of gallstone disease in Italy: results from a multicenter, population-based Italian study (the MICOL project). World J Gastroenterol 2008;14(34):5282–9.18785280
  12. Festi D, Reggiani MLB, Attili AF, Loria P, Pazzi P, Scaiolo E, et al. Natural history of gallstone disease: expectant management or active treatment? Results from a population‐based cohort study. J Gastroenterol Hepatol 2010;25(7):719–24.20492328
  13. Sakorafas GH, Milingos D, Peros G. Asymptomatic cholelithiasis: is cholecystectomy really needed? A critical reappraisal 15 years after the introduction of laparoscopic cholecystectomy. Dig Dis Sci 2007;52(5):1313–25.17390223
  14. Beckingham I. ABC of diseases of liver, pancreas, and biliary system: gallstone disease. BMJ 2001;322:91–4.11154626
  15. Friedman GD, Raviola CA, Fireman B. Prognosis of gallstones with mild or no symptoms: 25 years of follow-up in a health maintenance organization. J Clin Epidemiol 1989;42(1986):127–36.2918322
  16. Thistle J, Cleary P, Lachin J, Tyor M, Hersh T. The natural history of cholelithiasis: the National Cooperative Gallstone Study. Ann Intern Med 1984;101:171–5.6742647
  17. Attili AF, De Santis A, Capri R, Repice AM, Maselli S. The natural history of gallstones: the GREPCO experience. The GREPCO Group. Hepatology 1995;21(3):655–60.7875663
  18. McSherry CK, Ferstenberg H, Calhoun WF, Lahman E, Virshup M. The natural history of diagnosed gallstone disease in symptomatic and asymptomatic patients. Ann Surg 1985;202(1):59–63.4015212
  19. Berhane T, Vetrhus M, Hausken T, Olafsson S, Sondenaa K. Pain attacks in non-complicated and complicated gallstone disease have a characteristic pattern and are accompanied by dyspepsia in most patients: the results of a prospective study. Scand J Gastroenterol 2006;41(1):93–101.16373282
  20. Schmidt M, Dumot JA, Soreide O, Sondenaa K. Diagnosis and management of gallbladder calculus disease. Scand J Gastroenterol 2012;47(11):1257–65.22935027
  21. CholeS Study Group. West Midlands Research Collaborative: population-based cohort study of outcomes following cholecystectomy for benign gallbladder diseases. Br J Surg 2016;103(12):1704–15.27561954
  22. Larsen TK, Qvist N. The influence of gallbladder function on the symptomatology in gallstone patients, and the outcome after cholecystectomy or expectancy. Dig Dis Sci 2007;52(3):760–3.17245627
  23. Jorgensen T, Teglbjerg JS, Wille-Jorgensen P, Bille T, Thorvaldsen P. Persisting pain after cholecystectomy: a prospective investigation. Scand J Gastroenterol 1991;26(1):124–8.2006393
  24. Ahmed R, Freeman JV, Ross B, Kohler B, Nicholl JP, Johnson AG. Long term response to gallstone treatment: problems and surprises. Eur J Surg 2000;166(6):447–54.10890540
  25. Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJHM. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc 2013;27(3):709–18.23052498
  26. Girometti R, Brondani G, Cereser L, Como G, Del Pin M, Bazzocchi M, Zuiani C. Post-cholecystectomy syndrome: spectrum of biliary findings at magnetic resonance cholangiopancreatography. Br J Radiol 2010;83(988):351–61.20335441
  27. Luman W, Adams WH, Nixon SN, Mcintyre IM, Hamer-Hodges D, Wilson G, Palmer KR. Incidence of persistent symptoms after laparoscopic cholecystectomy: a prospective study. Gut 1996;39(6):863–6.9038671
  28. Schmidt M, Sondenaa K, Dumot JA, Rosenblatt S, Hausken T, Ramnefjell M, et al. Post-cholecystectomy symptoms were caused by persistence of a functional gastrointestinal disorder. World J Gastroenterol 2012;18(12):1365–72.22493550
  29. Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol 2005;40(11):1358–64.16334446
  30. van Dijk AH, de Reuver PR, Besselink MG, van Laarhoven KJ, Harrison EM, Wigmore SJ, et al. Assessment of available evidence in the management of gallbladder and bile duct stones: a systematic review of international guidelines. HPB (Oxford) 2017;19(4):297–309.28117228
  31. NHS England. 2019/20 National Cost Collection for the NHS data (Version 2). URL: www.england.nhs.uk/publication/2019-20-national-cost-collection-data-publication/?msclkid=a717fabdba4111ecae08168a6a0b8189 (accessed 1 December 2021).
  32. National Institute for Health and Care Excellence. Adult laparoscopic cholecystectomy 01/09/2010-31/10/2020. 10.5061/dryad.k9q7h
  33. Somasekar K, Shankar PJ, Foster ME, Lewis MH. Costs of waiting for gall bladder surgery. Postgrad Med J 2002;78(925):668–9.12496322
  34. Schmidt M, Hausken T, Glambek I, Schleer C, Eide GE, Sondenaa K. A 24-year controlled follow-up of patients with silent gallstones showed no long-term risk of symptoms or adverse events leading to cholecystectomy. Scand J Gastroenterol 2011;46(7–8):949–54.21501110
  35. Brazzelli M, Cruickshank M, Kilonzo M, Ahmed I, Stewart F, McNamee P, et al. Clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones or cholecystitis: a systematic review and economic evaluation. Health Technol Assess 2014;18(55):1–101, v.
  36. StataCorp. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC; 2019.
  37. Zou G. A modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol 2004;159(7):702–6.15033648
  38. WHO. WHO Director-General’s opening remarks at the media briefing on COVID-19: 11 March 2020. URL: www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 (accessed 4 November 2022).
  39. Treweek S, Gillies K, Innes K, MacLennan G. Sending Christmas cards to trial participants to improve retention. Trials 2017;18:406. URL: www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,846275,en.pdf (accessed 4 November 2022).28859674
  40. Coleman E, Arundel C, Clark L, Doherty L, Gillies K, Hewitt C, et al. Bah humbug! Association between sending Christmas cards to trial participants and trial retention: randomised study within a trial conducted simultaneously across eight host trials. BMJ 2021;375:e067742.34906985
  41. Duncan A, Innes K, Goulao B, Ramsay C. SWAT 145: The sticker SWAT: does a trial logo sticker placed on the outside of the envelope encourage the return of postal questionnaires. URL: www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,1140958,en.pdf (accessed 4 November 2022).
  42. Drummond M, Sculpher M, Claxton K, Stoddart G, Torrance G. Methods for the Economic Evaluation of Health Care Programmes. 4th edn. Oxford: Oxford University Press; 2015.
  43. Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic Evaluation in Clinical Trials. 2nd edn. Oxford: Oxford University Press; 2014.
  44. Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Appl Health Econ Health Policy 2022;20(2):213–21.35015207
  45. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21(2):271–92.11939242
  46. School of Health and Related Research. Measuring and Valuing Health. URL: www.sheffield.ac.uk/scharr/research/themes/valuing-health (accessed 4 November 2022).
  47. NHS Digital. Hospital Admitted Patient Care Activity 2020–21: Procedures and interventions. URL: https://digital.nhs.uk/data-and-information/publications/statistical/hospital-admitted-patient-care-activity/2020-21 (accessed 4 November 2022).
  48. Cooper K, Breeman S, Scott NW, Scotland G, Hernández R, Clark TJ, et al. Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT. Health Technol Assess 2019;23(53):1–108.
  49. Public Health Scotland. Data and Intelligence. URL: https://beta.isdscotland.org/topics/finance/file-listings-fy-2019-to-2020/ (accessed 4 November 2022).
  50. NHS Institute for Innovation and Improvement. Improving Quality and Efficiency in the Operating Theatre. URL: https://alesi-surgical.com/wp-content/uploads/2019/09/Improving-quality-and-efficiency-in-the-operating-theatre.pdf (accessed 4 November 2022).
  51. NHS Improvement. Archived Reference Costs. URL: https://webarchive.nationalarchives.gov.uk/ukgwa/20200501111106/https://improvement.nhs.uk/resources/reference-costs/ (accessed 4 November 2022).
  52. Curtis L, Burns A. Unit Costs of Health and Social Care 2020. 2020th edn. Canterbury: Personal Social Services Research Unit, University of Kent; 2020.
  53. National Institute for Health and Care Excellence. British National Formulary. URL: http://bnf.nice.org.uk/drug/ (accessed 4 November 2022).
  54. Cooper K, Breeman S, Scott NW, Scotland G, Clark J, Hawe J, et al.; HEALTH Study Group. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet 2019;394(10207):1425–36.31522846
  55. EUROQOL. URL: https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/faqs-2/ (accessed September 2022).
  56. StataCorp. Stata Statistical Software: Release 17. College Station, TX: StataCorp LLC; 2021.
  57. Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York: Wiley; 1987.
  58. Brand J, van Buuren S, le Cessie S, van den Hout W. Combining multiple imputation and bootstrap in the analysis of cost-effectiveness trial data. Stat Med 2019;38(2):210–20.30207407
  59. National Institute for Health and Care Excellence. Technology Appraisal Processes. URL: www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/process (accessed 4 November 2022).
  60. Schmidt M, Sondenaa K, Vetrhus M, Berhane T, Eide GE. A randomized controlled study of uncomplicated gallstone disease with a 14-year follow-up showed that operation was the preferred treatment. Dig Surg 2011;28(4):270–6.21757915
  61. National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal. National Institute for Health and Care Excellence, 2013. URL: www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781?msclkid=015aa049ba4211eca67d6ef9d3815df7 (accessed December 2017).
  62. Gary A, Clarke P, Wolstenholme S, Wordsworth S. Applied Methods of Cost-effective Analysis in Health Care. Oxford: Oxford University Press; 2011.
  63. Office for National Statistics. National Life Tables – Life Expectancy in the UK: 2018 to 2020. 23 September 2021. URL: www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/lifeexpectancies/bulletins/nationallifetablesunitedkingdom/2018to2020?msclkid=599e4de4ba4211ec9b9ec1408d1c6ed5/peoplepopulationandcommunity/birthsdeathsandmarriages/lifeexpectancies/bulletins/nationallifetablesunitedkingdom/2018to2020 (accessed 12 November 2022).
  64. van den Berg B. Sf-6D population norms. Health Econ 2012;21(12):1508–12.22250070
  65. Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health 2010;13(5):509–18.20230546
  66. National Institute for Health and Care Excellence. Gallstone Disease: Diagnosis and Management [CG188]. 2014. URL: www.nice.org.uk/guidance/cg188 (accessed 4 November 2022).
  67. Lawrie L, Duncan E, Dunsmore J, Newlands R, Gillies K. Using a behavioural approach to explore the factors that affect questionnaire return within a clinical trial: a qualitative study based on the theoretical domains framework. 2021. URL: https://bmjopen.bmj.com/content/11/4/e048128 (accessed 4 November 2022).
  68. Tunji-Ajayi P, Duncan EM, Gillies K. An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations. J Clin Epidemiol 2020;123:49–58.32229250
  69. Abrams P, Shearer K. The MASTER trial: artificial urinary sphincter versus male sling. Trends Urol Men’s Health. 2015;6(2):37–8.
  70. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, et al. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002;325(7367):766–70.12364308
  71. Rogers CA, Welbourn R, Byrne J, Donovan JL, Reeves BC, Wordsworth S, et al. The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase. Trials 2014;15:53.24517309
  72. Donovan JL, Rooshenas L, Jepson M, Elliott D, Wade J, Avery K, et al. Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials 2016;17(1):283.27278130
  73. Gillies K, Brehaut J, Coffey T, Duncan EM, Francis JJ, Hey SP, et al. How can behavioural science help us design better trials? Trials 2021;22(1):882.34863274
  74. Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci 2012;7:37.22530986
  75. Newlands R, Duncan E, Presseau J, Treweek S, Lawrie L, Bower P, et al. Why trials lose participants: a multitrial investigation of participants’ perspectives using the theoretical domains framework. J Clin Epidemiol 2021;137:1–13.33727134
  76. Lalu MM, Foster M, Presseau J, Dowlatshahi D, Castillo G, Cardenas A, et al. What are potential barriers and enablers to patient and physician participation in Canadian cell therapy trials for stroke? A stakeholder interview study. BMJ Open 2020;10(3):e034354.
  77. Castillo G, Lalu MM, Asad S, Foster M, Kekre N, Fergusson DA, et al. Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial. BMJ Open 2021;11(3):e043929.
  78. Lawrie L, Duncan EM, Jansen JO, Campbell MK, Brunsdon D, Skea Z, et al. Behavioural Optimisation to Address Trial Conduct Challenges: Case Study in the UK-REBOA Trial (Under Review with Trials). URL: www.researchsquare.com/article/rs-1166980/v1 (accessed 4 November 2022).
  79. Atkins L, Francis J, Islam R, O’Connor D, Patey A, Ivers N, et al. A guide to using the theoretical domains framework of behaviour change to investigate implementation problems. Implement Sci 2017;12(1):77.28637486
  80. Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med 2013;46(1):81–95.23512568
  81. Wilson C, Rooshenas L, Paramasivan S, Elliott D, Jepson M, Strong S, et al. Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework. Trials 2018;19(1):50.29351790
  82. Rooshenas L, Elliott D, Wade J, Jepson M, Paramasivan S, Strong S, et al.; ACST-2 Study Group. Conveying equipoise during recruitment for clinical trials: qualitative synthesis of clinicians’ practices across six randomised controlled trials. PLOS Med 2016;13(10):e1002147.27755555
  83. Donovan JL, Paramasivan S, de Salis I, Toerien M. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials 2014;15:5.24393291
  84. Paramasivan S, Strong S, Wilson C, Campbell B, Blazeby JM, Donovan JL. A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT – quanti-qualitative appointment timing. Trials 2015;16:88.25873096
  85. Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res 2016;26(13):1753–60.26613970
  86. Goulao B, Duncan A, Floate R, Clarkson J, Ramsay C. Three behavior change theory-informed randomized studies within a trial to improve response rates to trial postal questionnaires. J Clin Epidemiol 2020;122:35–41.32027931
  87. Kearney A, Rosala-Hallas A, Bacon N, Daykin A, Shaw ARG, Lane AJ, et al. Reducing attrition within clinical trials: the communication of retention and withdrawal within patient information leaflets. PLOS ONE 2018;13(10):e0204886.30379822
  88. Innes K, Cotton S, Campbell MK, Elliott J, Gillies K. Relative importance of informational items in participant information leaflets for trials: a Q-methodology approach. BMJ Open 2018;8(9):e023303.
  89. Cruickshank M, Newlands R, Blazeby J, Ahmed I, Bekheit M, Brazzelli M, et al. Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set. BMJ Open 2021;11(6):e045568.
  90. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P. Developing core outcome sets for clinical trials: issues to consider. Trials 2012;13:132.22867278
  91. Davis K, Gorst SL, Harman N, Smith V, Gargon E, Altman DG, et al. Choosing important health outcomes for comparative effectiveness research: an updated systematic review and involvement of low and middle income countries. PLOS ONE 2018;13(2):e0190695.29438429
  92. Comet Initiative. Development of Core Outcome Set for Symptomatic Uncomplicated Gallstone Disease. URL: www.comet-initiative.org/Studies/Details/927 (accessed 4 November 2022).
  93. Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET Handbook: version 1.0. Trials 2017;18(Suppl. 3):280.28681707
  94. Gurusamy KS, Samraj K, Fusai G, Davidson BR. Early versus delayed laparoscopic cholecystectomy for biliary colic. Cochrane Database Syst Rev 2008;2008(4):CD007196.
  95. Gurusamy KS, Koti R, Fusai G, Davidson BR. Early versus delayed laparoscopic cholecystectomy for uncomplicated biliary colic. Cochrane Database Syst Rev 2013;2013(6):CD007196.
  96. Gurusamy KS, Davidson C, Gluud C, Davidson BR. Early versus delayed laparoscopic cholecystectomy for people with acute cholecystitis. Cochrane Database Syst Rev 2013;2013(6):CD005440.
  97. Gurusamy KS, Samraj K, Fusai G, Davidson BR. Robot assistant versus human or another robot assistant in patients undergoing laparoscopic cholecystectomy. Cochrane Database Syst Rev 2012;2012(9):CD006578.
  98. Gurusamy KS, Vaughan J, Ramamoorthy R, Fusai G, Davidson BR. Miniports versus standard ports for laparoscopic cholecystectomy. Cochrane Database Syst Rev 2013;2013(8):CD006804.
  99. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res 2005;15(9):1277–88.16204405
  100. Hewitt-Taylor J. Use of constant comparative analysis in qualitative research. Nurs Stand 2001;15(42):39–42.
  101. Thomas J, Harden A. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol 2008;8:45.18616818
  102. Macefield RC, Jacobs M, Korfage IJ, Nicklin J, Whistance RN, Brookes ST, et al. Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs). Trials 2014;15:49.24495582
  103. Hopkins JC, Howes N, Chalmers K, Savovic J, Whale K, Coulman KD, et al.; By-Band Trial Management Group. Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT study. Obes Rev 2015;16(1):88–106.25442513
  104. Coulman KD, Hopkins J, Brookes ST, Chalmers K, Main B, Owen-Smith A, et al.; BARIACT Working Group. A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: the BARIACT project. PLOS Med 2016;13(11):e1002187.27898680
  105. Comet Initiative. DelphiManager. URL: www.comet-initiative.org/delphimanager/ (accessed 4 November 2022).
  106. Okoli C, Pawlowski SD. The Delphi method as a research tool: an example, design considerations and applications. Inform Manag 2004;42(1):15–29.
  107. Murphy MK, Black NA, Lamping DL, McKee CM, Sanderson CF, Askham J, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess 1998;2(3):i1–iv88.
  108. Aprea G, Coppola Bottazzi E, Guida F, Masone S, Persico G. Laparoendoscopic single site (LESS) versus classic video-laparoscopic cholecystectomy: a randomized prospective study. J Surg Res 2011;166(2):e109–12.21227454
  109. Artis T, Kucuk C, Akay A, Zararsiz G, Sozuer E. Prospective Randomized Study Comparing Single Incision vs. Standard Laparoscopic Cholecystectomy. URL: www.cochranelibrary.com/central/doi/10.1002/central/CN-01063839/full# (accessed 4 November 2022).
  110. UMIN-CTR Clinical Trial. Randomized Controlled Trial to Evaluate the Superiority of the Single Port Chlecystectomy (SPC) on Reduction of Postoperative Pain, Compared with the Conventional Laparoscopic Cholecystectomy at the Single Institution. URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003103 (accessed 4 November 2022).
  111. ClinicalTrials.gov. Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain. URL: https://clinicaltrials.gov/ct2/show/NCT01348620 (accessed 4 November 2022).
  112. Bignell M, Lewis MP, Cheong EC, Rhodes M. A prospective, randomized, single-blind trial of 5-mm versus 3-mm ports for laparoscopic cholecystectomy: is smaller better? Surg Endosc 2013;27(10):3616–21.23588709
  113. Bingener J, Skaran P, McConico A, Novotny P, Wettstein P, Sletten DM, et al. A double-blinded randomized trial to compare the effectiveness of minimally invasive procedures using patient-reported outcomes. J Am Coll Surg 2015;221(1):111–21.26095558
  114. Russell ML, Preshaw RM, Brant RF, Bultz BD, Page SA. Disease-specific quality of life: the Gallstone Impact Checklist. Clin Invest Med 1996;19(6):453–60.8959355
  115. Chen TY, Landmann MG, Potter JC, van Rij AM. Questionnaire to aid priority and outcomes assessment in gallstone disease. ANZ J Surg 2006;76(7):569–74.16813620
  116. Eypasch E, Wood-Dauphinée S, Williams JI, Ure B, Neugebauer E, Troidl H. The Gastrointestinal Quality of Life Index: a clinical index for measuring patient status in gastroenterologic surgery. Chirurg 1993;64(4):264–74.8482141
  117. Kleinbeck SV, Hoffart N. Outpatient recovery after laparoscopic cholecystectomy. AORN J 1994;60(3):394–402.7979326
  118. Urbach DR, Harnish JL, McIlroy JH, Streiner DL. A measure of quality of life after abdominal surgery. Qual Life Res 2006;15(6):1053–61.16900285
  119. Lindseth GN, Denny DL. Patients’ experiences with cholecystitis and a cholecystectomy. Gastroenterol Nurs 2014;37(6):407–14.25461462
  120. Psaila J, Agrawal S, Fountain U, Whitfield T, Murgatroyd B, Dunsire MF, et al. Day-surgery laparoscopic cholecystectomy: factors influencing same-day discharge. World J Surg 2008;32(1):76–81.17990027
  121. Comet Initiative. Advanced Search. URL: www.comet-initiative.org/Studies (accessed 12 November 2021).
  122. Remus A, Smith V, Gutke A, Mena JJS, Mørkved S, Wikmar LN, et al. A core outcome set for research and clinical practice in women with pelvic girdle pain: PGP-COS. PLOS ONE 2021;16(2):e0247466.33630941
  123. Chiarotto A, Ostelo RW, Turk DC, Buchbinder R, Boers M. Core outcome sets for research and clinical practice. Braz J Phys Ther 2017;21(2):77–84.28460714
  124. Daliya P, Gemmill EH, Lobo DN, Parsons SL. A systematic review of patient reported outcome measures (PROMs) and quality of life reporting in patients undergoing laparoscopic cholecystectomy. Hepatobiliary Surg Nutr 2019;8(3):228–45.31245403
  125. Alexander HC, Nguyen CH, Moore MR, Bartlett AS, Hannam JA, Poole GH, Merry AF. Measurement of patient-reported outcomes after laparoscopic cholecystectomy: a systematic review. Surg Endosc 2019;33(7):2061–71.30937619
  126. Comet Initiative. Identification and Categorisation of Relevant Outcomes for Symptomatic Uncomplicated Gallstone Disease: In-Depth Analysis to Inform the Development of a Core Outcome Set. URL: www.comet-initiative.org/Studies/Details/1909 (accessed 4 November 2022).
  127. SWORD Methods. SWORD Database Accessed Through AUGIS Website (Due to Lack of Funding This Database Closed in 2020). 2019.
  128. GOV.UK. Population of England and Wales. URL: www.ethnicity-facts-figures.service.gov.uk/uk-population-by-ethnicity/national-and-regional-populations/population-of-england-and-wales/latest (accessed 8 March 2022).
  129. Sacks GD, Dawes AJ, Ettner SL, Brook RH, Fox CR, Maggard-Gibbons M, et al. Surgeon perception of risk and benefit in the decision to operate. Ann Surg 2016;264(6):896–903.27192348
← DiscussionAdditional information →

Attribution. Karen Innes; Irfan Ahmed; Jemma Hudson; Rodolfo Hernández; Katie Gillies; Rebecca Bruce et al. (2024). Laparoscopic cholecystectomy versus conservative management for adults with uncomplicated symptomatic gallstones: the C-GALL RCT. National Institute for Health and Care Research. Copyright © 2024 Innes et al. Licensed under CC BY 4.0. NCBI Bookshelf NBK604683. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.

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