Study protocol: Population screening for colorectal cancer by colonoscopy or CT colonography: A randomized controlled trial

BMC Gastroenterology

Volumn 10, Issue , 2010, Pages

  de Wijkerslooth, Thomas R ^a   de Haan, Margriet C ^a   Stoop, Esther M ^b   Deutekom, Marije ^a   Fockens, Paul ^a   Bossuyt, Patrick M M ^a   Thomeer, Maarten ^b   van Ballegooijen, Marjolein ^b   Essink Bot, Marie Louise ^a   van Leerdam, Monique E ^b   Kuipers, Ernst J ^b   Dekker, Evelien ^a   Stoker, Jaap ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; CANCER SCREENING; CLINICAL TRIAL; COLONOSCOPY; COLORECTAL CANCER; COMPUTED TOMOGRAPHIC COLONOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DIAGNOSTIC VALUE; HEALTH CARE COST; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MASS SCREENING; OUTPATIENT CARE; PATIENT PARTICIPATION; RANDOMIZED CONTROLLED TRIAL; TELEMEDICINE; COLORECTAL TUMOR; CONSUMER; COST BENEFIT ANALYSIS; ECONOMICS; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; NETHERLANDS; PATIENT REFERRAL; RISK FACTOR; UTILIZATION REVIEW;

AGED; COLONOGRAPHY, COMPUTED TOMOGRAPHIC; COLONOSCOPY; COLORECTAL NEOPLASMS; CONSUMER PARTICIPATION; COST-BENEFIT ANALYSIS; HUMANS; MASS SCREENING; MIDDLE AGED; NETHERLANDS; REFERRAL AND CONSULTATION; RISK FACTORS;

EID: 77954041320     PISSN: None     EISSN: 1471230X     Source Type: Journal    
DOI: 10.1186/1471-230X-10-47     Document Type: Article

References (53)

1. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007, 18:581-592. 10.1093/annonc/mdl498, 17287242.
2. Integrale Kanker Centra. 2009, http://www.ikcnet.nl
3. Centraal Bureau voor de Statistiek. 2009, http://www.cbs.nl
4. Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, Ackroyd F, Shike M, Kurtz RC, Hornsby-Lewis L, Gerdes H, Stewart ET, . The National Polyp Study Workgroup Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med 1993, 329:1977-1981. 10.1056/NEJM199312303292701, 8247072, The National Polyp Study Workgroup.
5. Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet 1996, 348:1472-1477. 10.1016/S0140-6736(96)03386-7, 8942775.
6. Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet 1996, 348:1467-1471. 10.1016/S0140-6736(96)03430-7, 8942774.
7. Selby JV, Friedman GD, Quesenberry CP, Weiss NS. A case-control study of screening sigmoidoscopy and mortality from colorectal cancer. N Engl J Med 1992, 326:653-657.
8. Newcomb PA, Norfleet RG, Storer BE, Surawicz TS, Marcus PM. Screening sigmoidoscopy and colorectal cancer mortality. J Natl Cancer Inst 1992, 84:1572-1575. 10.1093/jnci/84.20.1572, 1404450.
9. Lansdorp-Vogelaar I, van Ballegooijen M, Zauber AG, Habbema JD, Kuipers EJ. Effect of Rising Chemotherapy Costs on the Cost Savings of Colorectal Cancer Screening. J Natl Cancer Inst 2009, 101:1412-1422. 10.1093/jnci/djp319, 19779203.
10. Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ, . American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology 2008, 134:1570-1595. 10.1053/j.gastro.2008.02.002, 18384785, American Cancer Society Colorectal Cancer Advisory Group; US Multi-Society Task Force; American College of Radiology Colon Cancer Committee.
11. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM. American college of gastroenterology guidelines for colorectal cancer screening 2008. Am J Gastroenterol 2009, 104:739-750. 10.1038/ajg.2009.104, 19240699.
12. Heresbach D, Manfredi S, D'halluin PN, Bretagne JF, Branger B. Review in depth and meta-analysis of controlled trials on colorectal cancer screening by faecal occult blood test. Eur J Gastroenterol Hepatol 2006, 18:427-433. 10.1097/00042737-200604000-00018, 16538116.
13. van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, van Krieken HH, Verbeek AL, Jansen JB, Dekker E. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology 2008, 135:82-90. 10.1053/j.gastro.2008.03.040, 18482589.
14. Hol L, Wilschut JA, van Ballegooijen M, van Vuuren AJ, van der Valk H, Reijerink JC, van der Togt AC, Kuipers EJ, Habbema JD, van Leerdam ME. Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels. Br J Cancer 2009, 100:1103-1110. 10.1038/sj.bjc.6604961, 2670000, 19337257.
15. van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, Jansen JB, Verbeek AL, Dekker E. Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme. Br J Cancer 2009, 101:1274-1281. 10.1038/sj.bjc.6605326, 19755997.
16. Segnan N, Senore C, Andreoni B, Azzoni A, Bisanti L, Cardelli A, Castiglione G, Crosta C, Ederle A, Fantin A, Ferrari A, Fracchia M, Ferrero F, Gasperoni S, Recchia S, Risio M, Rubeca T, Saracco G, Zappa M, . SCORE3 Working Group-Italy Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening. Gastroenterology 2007, 132:2304-2312. 10.1053/j.gastro.2007.03.030, 17570205, SCORE3 Working Group-Italy.
17. Hol L, van Leerdam ME, van Ballegooijen M, van Vuuren AJ, van Dekken H, Reijerink JC, van der Togt AC, Habbema JD, Kuipers EJ. Screening For Colorectal Cancer; Randomised Trial Comparing Guaiac-Based And Immunochemical Faecal Occult Blood Testing And Flexible Sigmoidoscopy. Gut 2010, 59:62-68. 10.1136/gut.2009.177089, 19671542.
18. Rockey DC, Paulson E, Niedzwiecki D, Davis W, Bosworth HB, Sanders L, Yee J, Henderson J, Hatten P, Burdick S, Sanyal A, Rubin DT, Sterling M, Akerkar G, Bhutani MS, Binmoeller K, Garvie J, Bini EJ, McQuaid K, Foster WL, Thompson WM, Dachman A, Halvorsen R. Analysis of air contrast barium enema, computed tomographic colonography, and colonoscopy: prospective comparison. Lancet 2005, 365:305-311.
19. Van Gossum A, Munoz-Navas M, Fernandez-Urien I, Carretero C, Gay G, Delvaux M, Lapalus MG, Ponchon T, Neuhaus H, Philipper M, Costamagna G, Riccioni ME, Spada C, Petruzziello L, Fraser C, Postgate A, Fitzpatrick A, Hagenmuller F, Keuchel M, Schoofs N, Devière J. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med 2009, 361:264-270. 10.1056/NEJMoa0806347, 19605831.
20. Singh H, Turner D, Xue L, Targownik LE, Bernstein CN. Risk of developing colorectal cancer following a negative colonoscopy examination: evidence for a 10-year interval between colonoscopies. JAMA 2006, 295:2366-2373. 10.1001/jama.295.20.2366, 16720822.
21. Brenner H, Chang-Claude J, Seiler CM, Sturmer T, Hoffmeister M. Does a negative screening colonoscopy ever need to be repeated?. Gut 2006, 55:1145-1150. 10.1136/gut.2005.087130, 1856263, 16469791.
22. van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol 2006, 101:343-350. 10.1111/j.1572-0241.2006.00390.x, 16454841.
23. Regula J, Rupinski M, Kraszewska E, Polkowski M, Pachlewski J, Orlowska J, Nowacki MP, Butruk E. Colonoscopy in colorectal-cancer screening for detection of advanced neoplasia. N Engl J Med 2006, 355:1863-1872. 10.1056/NEJMoa054967, 17079760.
24. Nelson DB, McQuaid KR, Bond JH, Lieberman DA, Weiss DG, Johnston TK. Procedural success and complications of large-scale screening colonoscopy. Gastrointest Endosc 2002, 55:307-314. 10.1067/mge.2002.121883, 11868001.
25. Panteris V, Haringsma J, Kuipers EJ. Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy 2009, 41:941-951. 10.1055/s-0029-1215179, 19866393.
26. Mulder SA, Ouwendijk RJ, Van Leerdam ME, Nagengast FM, Kuipers EJ. A nationwide survey evaluating adherence to guidelines for follow-up after polypectomy or treatment for colorectal cancer. J Clin Gastroenterol 2008, 42:487-492. 10.1097/MCG.0b013e31809e703c, 18344890.
27. Iannaccone R, Laghi A, Catalano C, Mangiapane F, Lamazza A, Schillaci A, Sinibaldi G, Murakami T, Sammartino P, Hori M, Piacentini F, Nofroni I, Stipa V, Passariello R. Computed tomographic colonography without cathartic preparation for the detection of colorectal polyps. Gastroenterology 2004, 127:1300-1311. 10.1053/j.gastro.2004.08.025, 15520999.
28. Lefere PA, Gryspeerdt SS, Dewyspelaere J, Baekelandt M, van Holsbeeck BG. Dietary fecal tagging as a cleansing method before CT colonography: initial results polyp detection and patient acceptance. Radiology 2002, 224:393-403. 10.1148/radiol.2241011222, 12147834.
29. Jensch S, de Vries AH, Peringa J, Bipat S, Dekker E, Baak LC, Bartelsman JF, Heutinck A, Montauban van Swijndregt AD, Stoker J. CT colonography with limited bowel preparation: performance characteristics in an increased-risk population. Radiology 2008, 247:122-132. 10.1148/radiol.2471070439, 18292475.
30. Halligan S, Altman DG, Taylor SA, Mallett S, Deeks JJ, Bartram CI, Atkin W. CT colonography in the detection of colorectal polyps and cancer: systematic review, meta-analysis, and proposed minimum data set for study level reporting. Radiology 2005, 237:893-904. 10.1148/radiol.2373050176, 16304111.
31. Pickhardt PJ, Choi JR, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, Wong RK, Nugent PA, Mysliwiec PA, Schindler WR. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med 2003, 349:2191-2200. 10.1056/NEJMoa031618, 14657426.
32. Kim DH, Pickhardt PJ, Taylor AJ, Leung WK, Winter TC, Hinshaw JL, Gopal DV, Reichelderfer M, Hsu RH, Pfau PR. CT colonography versus colonoscopy for the detection of advanced neoplasia. N Engl J Med 2007, 357:1403-1412. 10.1056/NEJMoa070543, 17914041.
33. Florie J, van Gelder RE, Schutter MP, van Randen A, Venema HW, de Jager S, Hulst VP, Prent A, Bipat S, Bossuyt PM, Baak LC, Stoker J. Feasibility study of computed tomography colonography using limited bowel preparation at normal and low-dose levels study. Eur Radiol 2007, 17:3112-3122. 10.1007/s00330-007-0668-0, 2077917, 17549490.
34. van Gelder RE, Birnie E, Florie J, Schutter MP, Bartelsman JF, Snel P, Laméris JS, Bonsel GJ, Stoker J. CT colonography and colonoscopy: assessment of patient preference in a 5-week follow-up study. Radiology 2004, 233:328-337. 10.1148/radiol.2331031208, 15358854.
35. Rodger J, Steele RJ. Telephone assessment increases uptake of colonoscopy in a FOBT colorectal cancer-screening programme. J Med Screen 2008, 15:105-107. 10.1258/jms.2008.007093, 18573779.
36. Denters MJ, Deutekom M, Fockens P, Bossuyt PM, Dekker E. Implementation of population screening for colorectal cancer by repeated fecal occult blood test in the Netherlands. BMC Gastroenterol 2009, 9:28. 10.1186/1471-230X-9-28, 2680893, 19393087.
37. van Dam L, Hol L, de Bekker-Grob EW, Steyerberg EW, Kuipers EJ, Habbema JD, Essink-Bot ML, van Leerdam ME. What determines individuals' preferences for colorectal cancer screening programmes? A discrete choice experiment. Eur J Cancer 2010, 46:150-159. 10.1016/j.ejca.2009.07.014, 19683432.
38. Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM. Quality indicators for colonoscopy. Gastrointest Endosc 2006, 63:S16-S28. 10.1016/j.gie.2006.02.021, 16564908.
39. Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med 2006, 355:2533-2541. 10.1056/NEJMoa055498, 17167136.
40. Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Fléjou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut 2000, 47:251-255. 10.1136/gut.47.2.251, 1728018, 10896917.
41. Liedenbaum MH, de Vries AH, van Rijn AF, Dekker HM, Willemssen FE, van Leerdam ME, van Marrewijk CJ, Fockens P, Bipat S, Bossuyt PM, Dekker E, Stoker J. CT colonography with limited bowel preparation for the detection of colorectal neoplasia in an FOBT positive screening population. Abdom Imaging 2009,
42. Burling D, . on behalf of the International Collaboration for CT colonography standards CT colonography standards. Clinical Radiology 2010, 65:272-278. on behalf of the International Collaboration for CT colonography standards.
43. Zalis ME, Barish MA, Choi JR, Dachman AH, Fenlon HM, Ferrucci JT, Glick SN, Laghi A, Macari M, McFarland EG, Morrin MM, Pickhardt PJ, Soto J, Yee J, . Working Group on Virtual Colonoscopy CT colonography reporting and data system: a consensus proposal. Radiology 2005, 236:3-9. 10.1148/radiol.2361041926, 15987959, Working Group on Virtual Colonoscopy.
44. Nagengast FM, Kaandorp CJ. [Revised CBO guideline 'Follow-up after polypectomy']. Ned Tijdschr Geneeskd 2001, 145:2022-2025.
45. Prismant Trends in tevredenheid, de tevredenheid van patiënten van de acht Universitair Medische Centra. NFU rapport 2008, Prismant.
46. van Rijn AF, Deutekom M, Fockens P, Bossuyt PM, van Rossum LG, Laheij RJ, Dekker E, Jansen JB. Are participants of the colorectal cancer screening program in the Netherlands wel informed?. Gut 2007, 56(Suppl III):A257.
47. van Rijn AF, van Rossum LG, Deutekom M, Fockens P, Bossuyt PM, Laheij RJ, Dekker E, Jansen JB. Why do subjects decline colorectal cancer screening by FOBT?. Gut 2007, 56(Suppl III):A257.
48. Janz NK, Becker MH. The Health Belief Model: a decade later. Health Educ Q 1984, 11:1-47.
49. Fransen M, Essink-Bot ML, Vogel I, Mackenbach JP, Steegers E, Wildschut H. Ethnic differences in informed decision-making about prenatal screening for Down syndrome. J Epidemiol Community Health 2010, 64:262-268. 10.1136/jech.2009.088237, 19692718.
50. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect 2001, 4:99-108. 10.1046/j.1369-6513.2001.00140.x, 11359540.
51. van den Bergh KA, Essink-Bot ML, van Klaveren RJ, de Koning HJ. Informed participation in a randomised controlled trial of computed tomography screening for lung cancer. Eur Respir J 2009, 34:711-720. 10.1183/09031936.00098908, 19282345.
52. Deutekom M, Terra MP, Dijkgraaf MG, Dobben AC, Stoker J, Boeckxstaens GE, Bossuyt PM. Patients' perception of tests in the assessment of faecal incontinence. Br J Radiol 2006, 79:94-100. 10.1259/bjr/63269033, 16489189.
53. Lansdorp-Vogelaar I, van Ballegooijen M, Zauber AG, Boer R, Wilschut J, Habbema JD. At what costs will screening with CT colonography be competitive? A cost-effectiveness approach. Int J Cancer 2009, 124:1161-1168. 10.1002/ijc.24025, 2859672, 19048626.