ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared with standard colonoscopy in patients at risk of colorectal disease – a study protocol Article Swipe
YOU?
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· 2025
· Open Access
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· DOI: https://doi.org/10.1136/bmjopen-2025-104661
Background Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity. Aims and objectives The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken. Methods We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice. Anticipated impact The study findings will provide the evidence base to inform future colorectal diagnostic services. Ethics and dissemination The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public. Trial registration number ISRCTN16126290 .
Related Topics
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2025-104661
- https://bmjopen.bmj.com/content/bmjopen/15/9/e104661.full.pdf
- OA Status
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- References
- 42
- OpenAlex ID
- https://openalex.org/W4414670029
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4414670029Canonical identifier for this work in OpenAlex
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https://doi.org/10.1136/bmjopen-2025-104661Digital Object Identifier
- Title
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ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared with standard colonoscopy in patients at risk of colorectal disease – a study protocolWork title
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articleOpenAlex work type
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enPrimary language
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2025Year of publication
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2025-09-01Full publication date if available
- Authors
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Hussain Ibrahim, Monica Haritakis, L. Ballantine, Kirsty McCormack, Seonaidh Cotton, Jemma Hudson, Karl Atkin, Stephen Rogers, Lisette Nixon, Abraham Verghese, Hayden Holmes, Shaun Treweek, Graeme MacLennan, Sunil Dolwani, Georgina Gardner, Chris Hurt, Angus Watson, James TurvillList of authors in order
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https://doi.org/10.1136/bmjopen-2025-104661Publisher landing page
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https://bmjopen.bmj.com/content/bmjopen/15/9/e104661.full.pdfDirect link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://bmjopen.bmj.com/content/bmjopen/15/9/e104661.full.pdfDirect OA link when available
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0Total citation count in OpenAlex
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42Number of works referenced by this work
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| abstract_inverted_index.disease | 7, 15, 94, 152, 296 |
| abstract_inverted_index.events, | 333 |
| abstract_inverted_index.growths | 22 |
| abstract_inverted_index.mirrors | 275 |
| abstract_inverted_index.needing | 67 |
| abstract_inverted_index.patient | 212, 360 |
| abstract_inverted_index.perform | 237 |
| abstract_inverted_index.pill’ | 114 |
| abstract_inverted_index.provide | 144, 161, 376 |
| abstract_inverted_index.public. | 431 |
| abstract_inverted_index.require | 58 |
| abstract_inverted_index.serious | 13 |
| abstract_inverted_index.swallow | 245 |
| abstract_inverted_index.through | 122 |
| abstract_inverted_index.trained | 77 |
| abstract_inverted_index.‘gold | 39 |
| abstract_inverted_index.(polyps) | 23 |
| abstract_inverted_index.331349). | 407 |
| abstract_inverted_index.Advisory | 270 |
| abstract_inverted_index.Measures | 313 |
| abstract_inverted_index.National | 169, 416 |
| abstract_inverted_index.accuracy | 188, 316 |
| abstract_inverted_index.accurate | 157 |
| abstract_inverted_index.approval | 392 |
| abstract_inverted_index.capacity | 88 |
| abstract_inverted_index.clinical | 214, 289, 424 |
| abstract_inverted_index.compared | 192 |
| abstract_inverted_index.delayed. | 97 |
| abstract_inverted_index.designed | 264 |
| abstract_inverted_index.diagnose | 150 |
| abstract_inverted_index.evaluate | 358 |
| abstract_inverted_index.evidence | 378 |
| abstract_inverted_index.findings | 374, 409 |
| abstract_inverted_index.increase | 167 |
| abstract_inverted_index.invasive | 48, 147 |
| abstract_inverted_index.involved | 309 |
| abstract_inverted_index.maximise | 311 |
| abstract_inverted_index.outcomes | 33 |
| abstract_inverted_index.patient. | 36 |
| abstract_inverted_index.patients | 428 |
| abstract_inverted_index.possible | 32 |
| abstract_inverted_index.reported | 319 |
| abstract_inverted_index.research | 230, 400 |
| abstract_inverted_index.sedation | 60 |
| abstract_inverted_index.standard | 276 |
| abstract_inverted_index.struggle | 52 |
| abstract_inverted_index.substudy | 340 |
| abstract_inverted_index.symptoms | 3 |
| abstract_inverted_index.Institute | 417 |
| abstract_inverted_index.agreement | 345 |
| abstract_inverted_index.capacity. | 174 |
| abstract_inverted_index.clinician | 362 |
| abstract_inverted_index.committee | 402 |
| abstract_inverted_index.contexts; | 290 |
| abstract_inverted_index.determine | 185 |
| abstract_inverted_index.diagnosis | 11, 91 |
| abstract_inverted_index.effective | 159 |
| abstract_inverted_index.endoscope | 101 |
| abstract_inverted_index.endoscopy | 73 |
| abstract_inverted_index.important | 27 |
| abstract_inverted_index.obtaining | 126 |
| abstract_inverted_index.patients. | 202 |
| abstract_inverted_index.performed | 70 |
| abstract_inverted_index.possible. | 280 |
| abstract_inverted_index.prevented | 330 |
| abstract_inverted_index.recruited | 285 |
| abstract_inverted_index.reference | 365, 404 |
| abstract_inverted_index.services. | 385 |
| abstract_inverted_index.suspected | 291, 293 |
| abstract_inverted_index.swallowed | 118 |
| abstract_inverted_index.undertake | 228 |
| abstract_inverted_index.‘camera | 111 |
| abstract_inverted_index.Background | 0 |
| abstract_inverted_index.analgesia. | 62 |
| abstract_inverted_index.assessment | 218 |
| abstract_inverted_index.attributed | 4 |
| abstract_inverted_index.clinically | 198 |
| abstract_inverted_index.colorectal | 6, 14, 18, 93, 106, 151, 383 |
| abstract_inverted_index.completion | 323 |
| abstract_inverted_index.diagnostic | 41, 173, 187, 315, 384 |
| abstract_inverted_index.evaluation | 204 |
| abstract_inverted_index.experience | 136 |
| abstract_inverted_index.meaningful | 199 |
| abstract_inverted_index.objectives | 177 |
| abstract_inverted_index.performed. | 348 |
| abstract_inverted_index.procedure. | 49 |
| abstract_inverted_index.procedures | 328 |
| abstract_inverted_index.retention. | 337 |
| abstract_inverted_index.specialist | 72 |
| abstract_inverted_index.24/NE/0178, | 405 |
| abstract_inverted_index.Anticipated | 370 |
| abstract_inverted_index.Colonoscopy | 45 |
| abstract_inverted_index.East—Tyne | 396 |
| abstract_inverted_index.Excellence, | 422 |
| abstract_inverted_index.alternative | 105 |
| abstract_inverted_index.colonoscopy | 85, 194, 327 |
| abstract_inverted_index.diagnostic. | 107 |
| abstract_inverted_index.established | 135 |
| abstract_inverted_index.experience, | 363 |
| abstract_inverted_index.experiences | 207 |
| abstract_inverted_index.intravenous | 59 |
| abstract_inverted_index.participant | 243 |
| abstract_inverted_index.potentially | 329 |
| abstract_inverted_index.standard’ | 40 |
| abstract_inverted_index.undertaken. | 224 |
| abstract_inverted_index.workstreams | 231 |
| abstract_inverted_index.colonoscopy. | 44, 259 |
| abstract_inverted_index.disseminated | 412 |
| abstract_inverted_index.inclusivity. | 312 |
| abstract_inverted_index.inflammation | 25 |
| abstract_inverted_index.inflammatory | 294 |
| abstract_inverted_index.outstripping | 87 |
| abstract_inverted_index.participants | 282 |
| abstract_inverted_index.precancerous | 21 |
| abstract_inverted_index.registration | 433 |
| abstract_inverted_index.stakeholders | 425 |
| abstract_inverted_index.acceptability | 367 |
| abstract_inverted_index.collaboration | 266 |
| abstract_inverted_index.dissemination | 388 |
| abstract_inverted_index.effectiveness | 221 |
| abstract_inverted_index.interobserver | 344 |
| abstract_inverted_index.intraobserver | 342 |
| abstract_inverted_index.participants, | 427 |
| abstract_inverted_index.surveillance. | 299 |
| abstract_inverted_index.(back-to-back) | 240 |
| abstract_inverted_index.ISRCTN16126290 | 435 |
| abstract_inverted_index.representative | 196, 288 |
| abstract_inverted_index.postpolypectomy | 298 |
| abstract_inverted_index.gastrointestinal | 2, 124 |
| abstract_inverted_index.cost-effectiveness | 354 |
| abstract_inverted_index.resource-intensive, | 66 |
| cited_by_percentile_year | |
| countries_distinct_count | 1 |
| institutions_distinct_count | 18 |
| citation_normalized_percentile.value | 0.59967557 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |