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. 2025 Nov 20:250:106056.
doi: 10.1016/j.puhe.2025.106056. Online ahead of print.

The effect of implementing colon capsule endoscopy in colorectal cancer screening on participation and sociodemographic inequalities: A parallel group randomised controlled trial

Ulrik Deding  1 , Lasse Kaalby  2 , Benedicte Schelde-Olesen  2 , Henrik Bøggild  3 , Thomas Bjørsum-Meyer  2 , Anastasios Koulaouzidis  2 , Morten Kobaek-Larsen  2 , Marianne Kirstine Thygesen  4 , Jonna Skov Madsen  5 , Gunnar Baatrup  2 ; CareForColon2015 study group
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The effect of implementing colon capsule endoscopy in colorectal cancer screening on participation and sociodemographic inequalities: A parallel group randomised controlled trial

Ulrik Deding et al. Public Health. .

Abstract

Objectives: Significant sociodemographic inequalities in participation in colorectal cancer (CRC) screening programmes across the globe are evident. We aimed to investigate the effect of introducing colon capsule endoscopy (CCE) as a filter test in faecal immunochemical test (FIT)-based CRC screening on overall FIT participation and social inequalities in FIT participation.

Study design: We conducted a randomised controlled trial, randomising 368,452 individuals.

Methods: Both groups received an invitation to submit a FIT sample, which elicited a follow-up investigation if ≥ 20 μg haemoglobin/g faeces was detected. The control group followed the standard screening pathway and was referred for follow-up colonoscopy. The intervention group were free to choose between colonoscopy and colon capsule endoscopy.

Results: The overall FIT participation proportion was significantly lower in the intervention group (63.4 %), compared to the control group (64.9 %). All sociodemographic subgroups in the intervention group had lower participation proportions than their control group counterpart, with an average of 1.4 (range 0.3-2.7) percentage points lower participation. The odds of non-participation, divided by sociodemographic characteristics, were not significantly different between interventions and controls for any subgroup, except for those aged 55-59 in which the odds ratios for non-participation was 1.59 (1.54-1.65) in the control group and 1.48 (1.43-1.53) in the intervention group, comparing them to those aged above 70.

Conclusions: Introducing a free choice between colon capsule endoscopy and colonoscopy if FIT positive did not increase FIT participation in CRC screening. Further, it did not affect the pattern of social inequalities in FIT uptake.

Keywords: Cancer prevention; Colonoscopy; Colorectal cancer; Colorectal cancer screening; Endoscopy; Equity; Inequality; Participation; Uptake.

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Conflict of interest statement

Declaration of competing interests GB is a co-founder and co-owner of Stratos AI Aps. BS-O has received honoraria payments from Jinshan. AK has received honoraria payments from Jinshan, Medtronic, Covidien and Norgine. UD has received honoraria payment from Norgine. All other authors declare: no support from any organisation for the submitted work, and no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years.

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