NCT01481337

Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin

Prospective Observatory of Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin : the "OPERA" Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 317 (actual)
• Sponsor: Société Française d'Endoscopie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Polyps

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-11-29
• Last updated: 2014-04-23

Locations

1 site across 1 country: France