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Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial
BACKGROUND: Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the pro...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813164/ https://www.ncbi.nlm.nih.gov/pubmed/33461579 http://dx.doi.org/10.1186/s13063-020-04996-7 |
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| author | Turan, Ayla S. Moons, Leon M. G. Schreuder, Ramon-Michel Schoon, Erik J. Terhaar sive Droste, Jochim S. Schrauwen, Ruud W. M. Straathof, Jan Willem Bastiaansen, Barbara A. J. Schwartz, Matthijs P. Hazen, Wouter L. Alkhalaf, Alaa Allajar, Daud Hadithi, Muhammed van der Spek, Bas W. Heine, Dimitri G. D. N. Tan, Adriaan C. I. T. L. de Graaf, Wilmar Boonstra, Jurjen J. Voogd, Fia J. Roomer, Robert de Ridder, Rogier J. J. Kievit, Wietske Siersema, Peter D. Didden, Paul van Geenen, Erwin J. M. |
| author_facet | Turan, Ayla S. Moons, Leon M. G. Schreuder, Ramon-Michel Schoon, Erik J. Terhaar sive Droste, Jochim S. Schrauwen, Ruud W. M. Straathof, Jan Willem Bastiaansen, Barbara A. J. Schwartz, Matthijs P. Hazen, Wouter L. Alkhalaf, Alaa Allajar, Daud Hadithi, Muhammed van der Spek, Bas W. Heine, Dimitri G. D. N. Tan, Adriaan C. I. T. L. de Graaf, Wilmar Boonstra, Jurjen J. Voogd, Fia J. Roomer, Robert de Ridder, Rogier J. J. Kievit, Wietske Siersema, Peter D. Didden, Paul van Geenen, Erwin J. M. |
| author_sort | Turan, Ayla S. |
| collection | PubMed |
| description | BACKGROUND: Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk. METHODS: The CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of < 1 cm between the clips. Primary outcome is delayed bleeding within 30 days after EMR. Secondary outcomes are recurrent or residual polyps and clip artifacts during surveillance colonoscopy after 6 months, as well as cost-effectiveness of prophylactic clipping and severity of delayed bleeding. DISCUSSION: The CLIPPER trial is a pragmatic study performed in the Netherlands and is powered to determine the real-time efficacy and cost-effectiveness of prophylactic clipping after EMR of proximal colon polyps ≥ 2 cm in the Netherlands. This study will also generate new data on the achievability of complete closure and the effects of clip placement on scar surveillance after EMR, in order to further promote the debate on the role of prophylactic clipping in everyday clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03309683. Registered on 13 October 2017. Start recruitment: 05 March 2018. Planned completion of recruitment: 31 August 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-020-04996-7. |
| format | Online Article Text |
| id | pubmed-7813164 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2021 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-78131642021-01-18 Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial Turan, Ayla S. Moons, Leon M. G. Schreuder, Ramon-Michel Schoon, Erik J. Terhaar sive Droste, Jochim S. Schrauwen, Ruud W. M. Straathof, Jan Willem Bastiaansen, Barbara A. J. Schwartz, Matthijs P. Hazen, Wouter L. Alkhalaf, Alaa Allajar, Daud Hadithi, Muhammed van der Spek, Bas W. Heine, Dimitri G. D. N. Tan, Adriaan C. I. T. L. de Graaf, Wilmar Boonstra, Jurjen J. Voogd, Fia J. Roomer, Robert de Ridder, Rogier J. J. Kievit, Wietske Siersema, Peter D. Didden, Paul van Geenen, Erwin J. M. Trials Study Protocol BACKGROUND: Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk. METHODS: The CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of < 1 cm between the clips. Primary outcome is delayed bleeding within 30 days after EMR. Secondary outcomes are recurrent or residual polyps and clip artifacts during surveillance colonoscopy after 6 months, as well as cost-effectiveness of prophylactic clipping and severity of delayed bleeding. DISCUSSION: The CLIPPER trial is a pragmatic study performed in the Netherlands and is powered to determine the real-time efficacy and cost-effectiveness of prophylactic clipping after EMR of proximal colon polyps ≥ 2 cm in the Netherlands. This study will also generate new data on the achievability of complete closure and the effects of clip placement on scar surveillance after EMR, in order to further promote the debate on the role of prophylactic clipping in everyday clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03309683. Registered on 13 October 2017. Start recruitment: 05 March 2018. Planned completion of recruitment: 31 August 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-020-04996-7. BioMed Central 2021-01-18 /pmc/articles/PMC7813164/ /pubmed/33461579 http://dx.doi.org/10.1186/s13063-020-04996-7 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| spellingShingle | Study Protocol Turan, Ayla S. Moons, Leon M. G. Schreuder, Ramon-Michel Schoon, Erik J. Terhaar sive Droste, Jochim S. Schrauwen, Ruud W. M. Straathof, Jan Willem Bastiaansen, Barbara A. J. Schwartz, Matthijs P. Hazen, Wouter L. Alkhalaf, Alaa Allajar, Daud Hadithi, Muhammed van der Spek, Bas W. Heine, Dimitri G. D. N. Tan, Adriaan C. I. T. L. de Graaf, Wilmar Boonstra, Jurjen J. Voogd, Fia J. Roomer, Robert de Ridder, Rogier J. J. Kievit, Wietske Siersema, Peter D. Didden, Paul van Geenen, Erwin J. M. Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial |
| title | Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial |
| title_full | Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial |
| title_fullStr | Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial |
| title_full_unstemmed | Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial |
| title_short | Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial |
| title_sort | clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (clipper): study protocol for a randomized controlled trial |
| topic | Study Protocol |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813164/ https://www.ncbi.nlm.nih.gov/pubmed/33461579 http://dx.doi.org/10.1186/s13063-020-04996-7 |
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