Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin (OPERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01481337
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):
VANBIERVLIET, Société Française d'Endoscopie Digestive

Brief 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

Condition or disease Intervention/treatment
Polyps Procedure: Colonic polypectomy or endoscopic mucosal resection (EMR)

Study Type : Observational
Actual Enrollment : 317 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Incidence of delayed bleeding after polypectomy and / or colonic mucosectomy (endoscopic mucosal resection) in patients on aspirin [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Incidence of immediate bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin [ Time Frame: one minute ]
  2. Efficacy of endoscopic hemostasis in case of bleeding induced [ Time Frame: During the lenght of endoscopy (colonoscopy) and at 30 days ]
  3. morbidity / mortality induced by immediate and delayed bleeding after polypectomy and / or colonic mucosectomy in patients on aspirin [ Time Frame: 30 days ]
  4. predictors of gastrointestinal bleeding post polypectomy / mucosectomy under aspirin by sub groups of patients obtained [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient under chronic aspirin therapy (antiplatelet agent) for cardiovascular reason who underwent colonic polypectomy or endoscopic mucosal resection.

Inclusion Criteria:

  • Age ≥ 18 years, male or female
  • Polypectomy AND / OR mucosectomy (EMR) performed on aspirin during a colonoscopy
  • Taking a single daily dose of aspirin long-term (<375 mg for more than 3 months) in the prevention of cardiovascular and thromboembolic risk with a major or medium - secondary prevention
  • Affiliation to the regime of national health protection
  • Informed consent and patient's written obtained
  • No participation in another clinical study

Exclusion Criteria:

  • Contraindications to the achievement of a lower gastrointestinal endoscopy
  • Taking a single daily dose of clopidogrel or other anti-platelet, anti vitamin K (AVK), heparin or anti bi aggregation in the context of cardiovascular prevention
  • Taking chronic anti inflammatory drug (at least once weekly)
  • Haemorrhagic disease, disorders of hemostasis and coagulation (PT <60%, aPTT> 40 sec. And platelets <60000/mm3), hematologic malignancy, chronic liver cirrhosis classified as Child Pugh B or C, acute or chronic renal failure
  • Patient with severe disease and progressive decompensated in the opinion of the investigator
  • Pregnant women, nursing
  • Not signing the written consent and / or mental disabilities of the subject making its participation in the trial impossible

Information from the National Library of Medicine

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 identifier (NCT number): NCT01481337

Archet 2 hospital
Nice, France, 06202
Sponsors and Collaborators
Société Française d'Endoscopie Digestive

Responsible Party: VANBIERVLIET, Director, Head of Endoscopy, Principal Investigator, Medical Doctor, Société Française d'Endoscopie Digestive Identifier: NCT01481337     History of Changes
Other Study ID Numbers: OPERA
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by VANBIERVLIET, Société Française d'Endoscopie Digestive:

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors