Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin (OPERA)
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|ClinicalTrials.gov Identifier: NCT01481337|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : April 23, 2014
The endoscopic management of patients on anti platelet agents is a wide problem more and more common, with prevalence of patients on this type of therapy steadily increasing. The risk of bleeding on antiplatelet during an endoscopic examination can be major. The risk of cardiovascular thrombotic accident in dirty shutdown of anti platelet, was recently described as significant (4-5%). Current recommendations for polypectomy allow the gesture as aspirin and are based on literature data scarce, often retrospective. Such work may be for a lack of increased bleeding risk during a colonic polypectomy under aspirin. There is to date no significant data published on the implementation of the endoscopic mucosal resection (mucosectomy) under aspirin. It is necessary to achieve a national multicenter observational study on a large scale in the daily practice of colonic polypectomy / mucosectomy in patient taking aspirin.
The aim of the study is to determine the incidence of immediate and delayed bleeding colonic polypectomy and mucosectomy with aspirin. The patients undergoing colonoscopy and taking a long-term aspirin therapy and presenting a major risk of thromboembolism or medium will incluables. Inclusion will be achieved for those patients receiving aspirin colonoscopy after signing a specific consent. Polypectomy will be possible according to the recommendations of the French Society of Digestive Endoscopy. Upon discovery of a lesion to be resected by mucosectomy, the patient will benefit from the mucosectomy. The study is observational, multicenter, prospective, national. The polypectomies / colonic mucosectomies will be made using the conventional techniques and the current recommendations. The immediate and delayed hemorrhage meet specific definitional criteria. The number of patients to be included will be 1000. The duration of the study inclusions will be 36 months. The trial will be conducted in full compliance with laws, regulations and ethical aspects.
It is expected in this work that the incidence of post-polypectomy bleeding under aspirin is the same. The rate of bleeding reported in the post mucosectomy size is higher compared to the polypectomy: it is however expected that the rate of bleeding in the post mucosectomy with or without aspirin is indifferent. It will follow a recommendation of French society adapted to endoscopy for this type of procedure
|Condition or disease||Intervention/treatment|
|Polyps||Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR)|
|Study Type :||Observational|
|Actual Enrollment :||317 participants|
|Official Title:||Prospective Observatory of Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin : the "OPERA" Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|Polypectomy or mucosal endoscopic resection under aspirin||
Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR)
Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation.
- Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on aspirin [ Time Frame: 30 days ]
- Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin [ Time Frame: one minute ]
- Efficacy of endoscopic hemostasis in case of bleeding induced [ Time Frame: During the lenght of endoscopy (colonoscopy) and at 30 days ]
- morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin [ Time Frame: 30 days ]
- predictors of gastrointestinal bleeding post polypectomy / mucosectomy under aspirin by sub groups of patients obtained [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481337
|Archet 2 hospital|
|Nice, France, 06202|