Abstract
Background
Adenoma detection rate (ADR) is the single most important measure of quality in colonoscopy, but little is known about the detection rate of serrated lesions (SLDR). To improve ADR, Endocuff Vision (EV) can be used. Studies have shown differing results as to the effect on ADR; an effect on SLDR has not been shown. To investigate the effect of Endocuff Vision on ADR in a screening population, this randomized controlled open label trial with concealed allocation was performed. Randomization to trial group was carried out by the endoscopist using prepared numbered envelopes.
Methods
Patients referred as part of the national bowel screening program at Regional Hospital Herning, Denmark were recruited and allocated to one of two groups: Endocuff Vision colonoscopy (EVC) and standard colonoscopy (SC). Outcomes were ADR, mean number, site, and size of lesions per procedure. SLDR as outcome was added after inclusion had begun.
Results
A total of 1178 participants were included, with 1166 (EVC 583 and SC 583) available for analysis. There was no clinical relevant difference in ADR (59.2% [CI 55.1; 63.1] v 60.5% [CI 56.5; 64.4]) or SLDR (13.0% [CI 10.5; 16.0] v 10.3% [CI 8.0; 13.0]) between groups. More serrated lesions were found per procedure (MSP) (0.2 v 0.1, IRR 57% [CI 17; 109]. Removal rate of EV was similar in the two study groups.
Conclusion
We found no significant effects of the use of Endocuff Vision on ADR, when compared to standard colonoscopy, but more serrated lesions were detected in the Endocuff group.
Trial registration
Clinical Trials NCT04651062.
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Abbreviations
- ADR:
-
Adenoma detection rate
- SLDR:
-
Serrated lesions detection rate
- EV:
-
Endocuff vision
- EVC:
-
Endocuff vision colonoscopy
- SC:
-
Standard colonoscopy
- CI:
-
Confidence interval
- SD:
-
Standard deviation
- IRR:
-
Incidence rate ratio
- iFobt:
-
Immunochemical fecal occult blood test
- iv:
-
Intravenous
- EMR:
-
Endoscopic mucosal resection
- TRUS:
-
Transrectal ultrasound
- TEM:
-
Transanal endoscopic microsurgery
- GI-histopathologists:
-
Gastrointestinal histopathologists
- WHO:
-
World health organization
- PDR:
-
Polyp detection rate
- MPP:
-
Mean number of polyps per procedure
- MAP:
-
Mean number of adenomas per procedure
- CIT:
-
Cecal intubation time
- MSP:
-
Mean number of serrated lesions per procedure
- MASP:
-
Mean number of adenoma and/or serrate lesions per procedure
- MNNP:
-
Mean number of non-neoplastic lesions per procedure
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Funding
This study was primarily funded by the surgical research department at Herning Regional Hospital West Jutland. Expenses for the purchase of Endocuff Vision were covered by Vissing Fonden, Aalborg, Denmark. Funding was provided by Vissing Fonden (dk) (Grant No. 54622).
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CJ contributed to conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, validation, visualization, and writing of the original draft. MHJ contributed to conceptualization, data curation, writing, reviewing, and editing of the manuscript. DHC contributed to formal analysis, validation, writing, reviewing, and editing of the manuscript. AHM contributed to project administration, resources, supervision, writing, reviewing, and editing of the manuscript. MRM contributed to conceptualization, investigation, methodology, project administration, resources, and supervision.
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Drs. Claudia Jaensch, Mogens Harrits Jepsen, David Høyrup Christiansen, Anders Husted Madsen, and Mogens Rørbæk Madsen have no conflicts of interest or financial ties to disclose.
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Jaensch, C., Jepsen, M.H., Christiansen, D.H. et al. Adenoma and serrated lesion detection with distal attachment in screening colonoscopy: a randomized controlled trial. Surg Endosc 36, 1–9 (2022). https://doi.org/10.1007/s00464-022-09049-5
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DOI: https://doi.org/10.1007/s00464-022-09049-5