Colonoscopy-related complications in a nationwide immunochemical fecal occult blood test-based colorectal cancer screening program

Ellen M Mikkelsen; Mette Kielsholm Thomsen; Julie Tybjerg; Lennart Friis-Hansen; Berit Andersen; Jens Christian Riis Jørgensen; Gunnar Baatrup; Sisse H Njor; Frank Mehnert; Morten Rasmussen

doi:10.2147/CLEP.S181204

Colonoscopy-related complications in a nationwide immunochemical fecal occult blood test-based colorectal cancer screening program

Clin Epidemiol. 2018 Nov 13:10:1649-1655. doi: 10.2147/CLEP.S181204. eCollection 2018.

Authors

Affiliations

¹ Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark, em@clin.au.dk.
² RKKP, The Danish Clinical Registries, A National Quality Improvement Programme, Aarhus, Denmark.
³ Department of Clinical Biochemistry, Nordsjællands Hospital, Hillerød, Denmark.
⁴ Department of Public Health Programmes, Randers Regional Hospital, The Central Denmark Region, Randers, Denmark.
⁵ Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
⁶ Department of Surgery, Vejle Hospital, Vejle, Denmark.
⁷ Department of Surgery, Odense University Hospital, Odense, Denmark.
⁸ Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
⁹ Department of Digestive Diseases K, Bispebjerg Hospital, Copenhagen, Denmark.

Abstract

Background: The Danish national screening program for colorectal cancer (CRC) consists of an immunochemical fecal occult blood test (iFOBT) followed by colonoscopy. The Danish Colorectal Cancer Screening Database (DCCSD) records data on the incidence of hospital-registered complications after colonoscopy. However, the validity of these data is unknown, and the incidence of complications is potentially underreported.

Objective: To evaluate the validity of the colonoscopy complications registered in the DCCSD by using medical records as the reference. Further, to evaluate the incidence of complications leading to hospital contact.

Methods: Among 14,671 individuals with a positive iFOBT result and a colonoscopy procedure performed from March 3, 2014 to December 31, 2014, we selected 295 individuals for medical record review. We calculated sensitivity as the proportion of true complications registered in the DCCSD out of all complications found in the medical records, and the positive predictive value (PPV) as the number of true complications in the DCCSD out of all DCCSD-registered complications. On the basis of the medical record data, we calculated the incidence proportion of hospital-registered complications overall and by subtype.

Results: In total, we reviewed 286 records and found 102 individuals with at least one complication. The sensitivity of the DCCSD for any complication was 29.4% (95% CI: 20.8-39.3) and the PPV was 88.2% (95% CI: 72.6-96.7). On the basis of the medical record data, the incidence proportion of any complication after colonoscopy was 0.70% (95% CI: 0.57-0.84) and that of perforation or lesion was 0.10% (95% CI: 0.06-0.17); bleeding, 0.41% (95% CI: 0.31-0.53); post-polypectomy syndrome, 0.16% (95% CI: 0.10-0.24); and other medical complications, 0.04 (95% CI: 0.02-0.09).

Conclusion: The DCCSD has low sensitivity for complications, and improvements in data registration are warranted. The incidence proportion of any hospital-treated post-colonoscopy complication was 0.70% in 2014, which was the first year of the Danish national CRC screening program. This is within the range of complications reported by other studies.

Keywords: harms; prevention; public health.