Rationale and design of the European Polyp Surveillance (EPoS) trials
Background: Current guidelines recommend surveillance colonoscopies after polyp removal depending on the number and characteristics of polyps, but there is a lack of evidence supporting the recommendations. This report outlines the rationale and design of two randomized trials and one observational...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal Article |
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2016
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| Online Access: | http://hdl.handle.net/20.500.11937/49808 |
| _version_ | 1848758320356130816 |
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| author | Jover, R. Bretthauer, M. Dekker, E. Holme, O. Kaminski, M. Loberg, M. Zauber, A. Hernán, M. Lansdorp-Vogelaar, Iris Sunde, A. McFadden, E. Castells, A. Regula, J. Quintero, E. Pellisé, M. Senore, C. Kalager, M. Dinis-Ribeiro, M. Emilsson, L. Ransohoff, D. Hoff, G. Adami, H. |
| author_facet | Jover, R. Bretthauer, M. Dekker, E. Holme, O. Kaminski, M. Loberg, M. Zauber, A. Hernán, M. Lansdorp-Vogelaar, Iris Sunde, A. McFadden, E. Castells, A. Regula, J. Quintero, E. Pellisé, M. Senore, C. Kalager, M. Dinis-Ribeiro, M. Emilsson, L. Ransohoff, D. Hoff, G. Adami, H. |
| author_sort | Jover, R. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | Background: Current guidelines recommend surveillance colonoscopies after polyp removal depending on the number and characteristics of polyps, but there is a lack of evidence supporting the recommendations. This report outlines the rationale and design of two randomized trials and one observational study investigating evidence-based surveillance strategies following polyp removal. Study design and endpoints: The EPoS studies started to recruit patients in April 2015. EPoS study I randomizes 13 746 patients with low-risk adenomas (1 – 2 tubular adenomas size < 10 mm, low-grade dysplasia) to surveillance after 5 and 10 years, or 10 years only. EPoS study II randomizes 13 704 patients with high-risk adenomas (3 – 10 adenomas or adenoma ≥ 10 mm in diameter, or adenoma with high-grade dysplasia, or > 25 % villous features) to surveillance after 3, 5, and 10 years, or 5 and 10 years only. EPoS study III offers surveillance after 5 and 10 years to patients with serrated polyps ≥ 10 mm in diameter at any location, or serrated polyps ≥ 5 mm in diameter proximal to the splenic flexure. All polyps are removed before patients enter the trials. The primary end point is colorectal cancer incidence after 10 years. We assume a colorectal cancer risk of 1 % for patients in EPoS I, and 2 % for patients in EPoS II. Using a noninferiority hypothesis with an equivalence interval of 0.5 % for EPoS I and 0.7 % for EPoS II, the trials are 90 % powered to uncover differences larger than the equivalence intervals. For EPoS III, no power analyses have been performed. |
| first_indexed | 2025-11-14T09:42:07Z |
| format | Journal Article |
| id | curtin-20.500.11937-49808 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T09:42:07Z |
| publishDate | 2016 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-498082018-03-29T09:07:47Z Rationale and design of the European Polyp Surveillance (EPoS) trials Jover, R. Bretthauer, M. Dekker, E. Holme, O. Kaminski, M. Loberg, M. Zauber, A. Hernán, M. Lansdorp-Vogelaar, Iris Sunde, A. McFadden, E. Castells, A. Regula, J. Quintero, E. Pellisé, M. Senore, C. Kalager, M. Dinis-Ribeiro, M. Emilsson, L. Ransohoff, D. Hoff, G. Adami, H. Background: Current guidelines recommend surveillance colonoscopies after polyp removal depending on the number and characteristics of polyps, but there is a lack of evidence supporting the recommendations. This report outlines the rationale and design of two randomized trials and one observational study investigating evidence-based surveillance strategies following polyp removal. Study design and endpoints: The EPoS studies started to recruit patients in April 2015. EPoS study I randomizes 13 746 patients with low-risk adenomas (1 – 2 tubular adenomas size < 10 mm, low-grade dysplasia) to surveillance after 5 and 10 years, or 10 years only. EPoS study II randomizes 13 704 patients with high-risk adenomas (3 – 10 adenomas or adenoma ≥ 10 mm in diameter, or adenoma with high-grade dysplasia, or > 25 % villous features) to surveillance after 3, 5, and 10 years, or 5 and 10 years only. EPoS study III offers surveillance after 5 and 10 years to patients with serrated polyps ≥ 10 mm in diameter at any location, or serrated polyps ≥ 5 mm in diameter proximal to the splenic flexure. All polyps are removed before patients enter the trials. The primary end point is colorectal cancer incidence after 10 years. We assume a colorectal cancer risk of 1 % for patients in EPoS I, and 2 % for patients in EPoS II. Using a noninferiority hypothesis with an equivalence interval of 0.5 % for EPoS I and 0.7 % for EPoS II, the trials are 90 % powered to uncover differences larger than the equivalence intervals. For EPoS III, no power analyses have been performed. 2016 Journal Article http://hdl.handle.net/20.500.11937/49808 10.1055/s-0042-104116 restricted |
| spellingShingle | Jover, R. Bretthauer, M. Dekker, E. Holme, O. Kaminski, M. Loberg, M. Zauber, A. Hernán, M. Lansdorp-Vogelaar, Iris Sunde, A. McFadden, E. Castells, A. Regula, J. Quintero, E. Pellisé, M. Senore, C. Kalager, M. Dinis-Ribeiro, M. Emilsson, L. Ransohoff, D. Hoff, G. Adami, H. Rationale and design of the European Polyp Surveillance (EPoS) trials |
| title | Rationale and design of the European Polyp Surveillance (EPoS) trials |
| title_full | Rationale and design of the European Polyp Surveillance (EPoS) trials |
| title_fullStr | Rationale and design of the European Polyp Surveillance (EPoS) trials |
| title_full_unstemmed | Rationale and design of the European Polyp Surveillance (EPoS) trials |
| title_short | Rationale and design of the European Polyp Surveillance (EPoS) trials |
| title_sort | rationale and design of the european polyp surveillance (epos) trials |
| url | http://hdl.handle.net/20.500.11937/49808 |