Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

Autor: Turan, A.S., Moons, L.M.G., Schreuder, R.M., Schoon, E.J., Droste, J.S.T.S., Schrauwen, R.W.M., Straathof, J.W., Bastiaansen, B.A.J., Schwartz, M.P., Hazen, W.L., Alkhalaf, A., Allajar, D., Hadithi, M., Spek, B.W. van der, Heine, D.G.D.N., Tan, A.C.I.T.L., Graaf, W. de, Boonstra, J.J., Voogd, F.J., Roomer, R., Ridder, R.J.J. de, Kievit, W., Siersema, P.D., Didden, P., Geenen, E.J.M. van, Dutch EMR Study Grp
Přispěvatelé: RS: FHML non-thematic output, MUMC+: MA Maag Darm Lever (9), Interne Geneeskunde, Gastroenterology & Hepatology, Gastroenterology and Hepatology, CCA - Cancer Treatment and Quality of Life, Amsterdam Gastroenterology Endocrinology Metabolism
Rok vydání: 2021
Předmět:
Colorectal cancer
medicine.medical_treatment
Medicine (miscellaneous)
Endoscopic mucosal resection
law.invention
Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14]
Study Protocol
HEMORRHAGE
0302 clinical medicine
Randomized controlled trial
law
Multicenter Studies as Topic
Medicine
Pharmacology (medical)
POLYPECTOMY
CLIPS
Clipper (electronics)
Netherlands
Randomized Controlled Trials as Topic
computer.programming_language
lcsh:R5-920
Incidence (epidemiology)
Colonoscopy
Surgical Instruments
surgical procedures
operative
030220 oncology & carcinogenesis
030211 gastroenterology & hepatology
POSTPOLYPECTOMY
lcsh:Medicine (General)
medicine.medical_specialty
Endoscopic Mucosal Resection
Colon
emr
Colonic Polyps
Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0]
Postoperative Hemorrhage
digestive system
03 medical and health sciences
All institutes and research themes of the Radboud University Medical Center
prophylactic clipping
Humans
Colonic polyp
Clip artifact
business.industry
COLORECTAL LESIONS
Clipping (medicine)
medicine.disease
Surgery
LARGE SESSILE
CLOSURE
Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5]
RISK-FACTORS
Delayed bleeding
business
Complication
computer
COSTS
Zdroj: Trials, 22
Trials, 22(1):63. BioMed Central Ltd
Trials, 22(1):63. BioMed Central Ltd.
Trials
Trials, Vol 22, Iss 1, Pp 1-9 (2021)
Trials, 22(1):63. BioMed Central
Trials, 22, 1
Trials, 22(1). BMC
ISSN: 1745-6215
Popis: 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 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.
Databáze: OpenAIRE
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