Polyps Clinical Trial
Official title:
Prospective Observatory of Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin : the "OPERA" Study
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
n/a
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Not yet recruiting |
NCT02754050 -
Safety and Feasibility of the Tandem Snare Device
|
N/A | |
Recruiting |
NCT02545699 -
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
|
N/A | |
Completed |
NCT02617992 -
Systematic Wide-Field EMR Scar Assessment and Therapy Audit
|
||
Completed |
NCT01688557 -
Trial on Innovative Technologies in Colonoscopy
|
N/A | |
Completed |
NCT02470416 -
Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas
|
N/A | |
Recruiting |
NCT00237276 -
Experience and Enhancement: Improving Colonoscopic Polyp Detection
|
N/A | |
Completed |
NCT00234650 -
Adenoma Detection Rate With Position Change at Colonoscopy
|
N/A | |
Recruiting |
NCT06096948 -
Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection
|
N/A | |
Recruiting |
NCT05042947 -
A New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection
|
N/A | |
Completed |
NCT02937506 -
Patient Satisfaction With Propofol for Out Patient Colonoscopy
|
Phase 4 | |
Active, not recruiting |
NCT01369758 -
MyoSure Hysteroscopic Tissue Removal System Registry Study
|
Phase 4 | |
Completed |
NCT00979342 -
Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System
|
N/A | |
Completed |
NCT00553436 -
Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
|
N/A | |
Completed |
NCT00577083 -
Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates
|
N/A | |
Recruiting |
NCT03868605 -
Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia
|
N/A | |
Completed |
NCT01917513 -
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
|
N/A | |
Completed |
NCT01807169 -
Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel
|
Phase 4 | |
Active, not recruiting |
NCT03708952 -
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer and Cardiometabolic Diseases
|
||
Completed |
NCT03146052 -
Comparison Between Asymmetric And Standard Split-Dose Regimen For Bowel Preparation
|
N/A |