Subscribe to RSS

DOI: 10.1055/a-2695-6904
Colon capsule endoscopy compared with conventional colonoscopy in patients with colonic diverticulitis: a randomized controlled superiority trial on patient-reported outcomes
Authors
Supported by: CICA (Centre for Clinical Implementation of Capsule Endoscopy)
Clinical Trial:
Registration number (trial ID): NC05700981, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Randomized

Abstract
Background
In the Danish health care system, follow-up colonoscopy is standard after a colonic diverticulitis episode in order to exclude malignancy. Colon capsule endoscopy (CCE) is a diagnostic alternative to colonoscopy. This study compared patient-reported outcomes of CCE versus colonoscopy after diverticulitis episodes.
Methods
A randomized controlled trial was conducted in patients with computed tomography-verified diverticulitis from Odense University Hospital. Patients were randomized to either CCE or colonoscopy 4–6 weeks after discharge. The primary outcome was patient-reported experienced physical and mental discomfort related to the procedures. Secondary outcomes were expected physical and mental discomfort, examination preference, proportion of complete examinations, and frequency of polyps and colorectal cancer.
Results
159 patients were randomized, with 148 receiving their allocated intervention and 83 completing the questionnaires. Demographic data were comparable between the two groups. No adverse events were observed. Patients expected greater physical and mental discomfort with colonoscopy than with CCE. However, no significant difference was found in experienced physical and mental discomfort between CCE and colonoscopy. For hypothetical future events, 49% of patients would prefer CCE, 13% would prefer colonoscopy, and 38% did not know. Complete examinations were reported for 84% of CCEs and 92% of colonoscopies. No malignant lesions were found.
Conclusions
CCE was a safe follow-up procedure after a diverticulitis episode. CCE was preferred to colonoscopy by most patients who reported their experience. No difference was observed regarding experienced physical and mental discomfort between the groups completing the questionnaires.
Publication History
Received: 06 December 2024
Accepted after revision: 17 August 2025
Accepted Manuscript online:
04 September 2025
Article published online:
17 October 2025
© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
-
References
- 1 Rustom LBO, Sharara AI. The natural history of colonic diverticulosis: much ado about nothing?. Inflamm Intest Dis 2018; 3: 69-74
- 2 Peery AF, Keku TO, Martin CF. et al. Distribution and characteristics of colonic diverticula in a United States screening population. Clin Gastroenterol Hepatol 2016; 14: 980-985.e981
- 3 Zullo A, Gatta L, Vassallo R. et al. Paradigm shift: the Copernican revolution in diverticular disease. Ann Gastroenterol 2019; 32: 541-553
- 4 Peery AF, Keku TO, Galanko JA. et al. Sex and race disparities in diverticulosis prevalence. Clin Gastroenterol Hepatol 2020; 18: 1980-1986
- 5 Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part II: lower gastrointestinal diseases. Gastroenterology 2009; 136: 741-754
- 6 Walker MM, Harris AK. Pathogenesis of diverticulosis and diverticular disease. Minerva Gastroenterol Dietol 2017; 63: 99-109
- 7 Shahedi K, Fuller G, Bolus R. et al. Long-term risk of acute diverticulitis among patients with incidental diverticulosis found during colonoscopy. Clin Gastroenterol Hepatol 2013; 11: 1609-1613
- 8 Kozak LJ, DeFrances CJ, Hall MJ. National hospital discharge survey: 2004 annual summary with detailed diagnosis and procedure data. Vital Health Stat 2006; 13: 1-209
- 9 Sandler RS, Everhart JE, Donowitz M. et al. The burden of selected digestive diseases in the United States. Gastroenterology 2002; 122: 1500-1511
- 10 Ünlü Ç, Gunadi PM, Gerhards MF. et al. Outpatient treatment for acute uncomplicated diverticulitis. Eur J Gastroenterol Hepatol 2013; 25: 1038-1043
- 11 Sartelli M, Moore FA, Ansaloni L. et al. A proposal for a CT driven classification of left colon acute diverticulitis. World J Emerg Surg 2015; 10: 3
- 12 Miller AS, Boyce K, Box B. et al. The Association of Coloproctology of Great Britain and Ireland consensus guidelines in emergency colorectal surgery. Colorectal Dis 2021; 23: 476-547
- 13 Kaiser AM, Jiang JK, Lake JP. et al. The management of complicated diverticulitis and the role of computed tomography. Am J Gastroenterol 2005; 100: 910-917
- 14 Rottier SJ, van Dijk ST, van Geloven AAW. et al. Meta-analysis of the role of colonoscopy after an episode of left-sided acute diverticulitis. Br J Surg 2019; 106: 988-997
- 15 Meyer J, Orci LA, Combescure C. et al. Risk of colorectal cancer in patients with acute diverticulitis: a systematic review and meta-analysis of observational studies. Clin Gastroenterol Hepatol 2019; 17: 1448-1456.e1417
- 16 Redd WD, Holub JL, Nichols HB. et al. Follow-up colonoscopy for detection of missed colorectal cancer after diverticulitis. Clin Gastroenterol Hepatol 2024; 22: 2125-2133
- 17 Pasha SF. Applications of colon capsule endoscopy. Curr Gastroenterol Rep 2018; 20: 22
- 18 Spada C, Hassan C, Galmiche JP. et al. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2012; 44: 527-536
- 19 Thygesen MK, Baatrup G, Petersen C. et al. Screening individuals’ experiences of colonoscopy and colon capsule endoscopy; a mixed methods study. Acta Oncol 2019; 58: S71-s76
- 20 Deding U, Cortegoso Valdivia P, Koulaouzidis A. et al. Patient-reported outcomes and preferences for colon capsule endoscopy and colonoscopy: a systematic review with meta-analysis. Diagnostics 2021; 11: 1730
- 21 Leighton JA, Rex DK. A grading scale to evaluate colon cleansing for the PillCam COLON capsule: a reliability study. Endoscopy 2011; 43: 123-127
- 22 Spada C, Hassan C, Bellini D. et al. Imaging alternatives to colonoscopy: CT colonography and colon capsule. European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastrointestinal and Abdominal Radiology (ESGAR) Guideline – update 2020. European Radiol 2021; 31: 2967-2982
- 23 Pickhardt PJ, Pooler BD, Kim DH. et al. The natural history of colorectal polyps: overview of predictive static and dynamic features. Gastroenterol Clin North Am 2018; 47: 515-536
- 24 Kobaek-Larsen M, Kroijer R, Dyrvig AK. et al. Back-to-back colon capsule endoscopy and optical colonoscopy in colorectal cancer screening individuals. Colorectal Dis 2018; 20: 479-485
- 25 Kaalby L, Deding U, Kobaek-Larsen M. et al. Colon capsule endoscopy in colorectal cancer screening: a randomised controlled trial. BMJ Open Gastroenterol 2020; 7: e000411
- 26 Sealed Envelope Ltd. 2012. Power calculator for continuous outcome superiority trial. Accessed September 05, 2025 at: https://www.sealedenvelope.com/power/continuous-superiority/
- 27 StataCorp. Stata: Release 15. Statistical Software. College Station, TX: StataCorp LLC; 2017.
- 28 Britton EJ, Sidhu S, Geraghty J. et al. The 5-year outcome of patients having incomplete colonoscopy. Colorectal Dis 2015; 17: 298-303
- 29 Inc. SI. SAS/STAT 15.3 User’s Guide. Cary, NC: SAS Institute Inc.; 2023
- 30 Manuguerra M, Heller GZ. Ordinal regression models for continuous scales. Int J Biostat 2010; 6: Article 14
- 31 Heller GZ, Manuguerra M, Chow R. How to analyze the visual analogue scale: myths, truths and clinical relevance. Scand J Pain 2016; 13: 67-75
- 32 Manuguerra M, Heller GZ, Ma J. Continuous ordinal regression for analysis of visual analogue scales: the R package ordinalCont. J Stat Softw 2020; 96: 1-25
- 33 R Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2017
- 34 Schelde-Olesen B, Kaalby L, Deding U. et al. Colon CApsule endoscopy compared to conventional COlonoscopy in patients with colonic DIverticulitis: the study protocol for a randomised controlled superiority trial (CACODI trial). BMJ Open 2023; 13: e073575
- 35 Kaminski MF, Thomas-Gibson S, Bugajski M. et al. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2017; 49: 378-397
- 36 Cao AMY, Lam VW, Rickard M. Endoscopic findings after CT proven acute diverticulitis: a systematic review and meta-analysis. ANZ J Surg 2023; 93: 1150-1158
- 37 Van Gossum A, Munoz-Navas M, Fernandez-Urien I. et al. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med 2009; 361: 264-270
- 38 Eliakim R, Yassin K, Niv Y. et al. Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy. Endoscopy 2009; 41: 1026-1031
