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Efficacy of cold snare polypectomy for the patients taking anticoagulants; Prospective, open label, randomized controlled trial.

Phase 3
Conditions
on-pedunculated subcentimetric colorectal polyp (adenoma or sessile serrated adenoma/polyp)
Registration Number
JPRN-UMIN000022461
Lead Sponsor
Team "Madowazu"
Brief Summary

The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
184
Inclusion Criteria

Not provided

Exclusion Criteria

1.Previous enrollment to this study. 2.Inflammatory bowel disease, polyposis patient. 3.Polyps larger than 10mm, lesions suspicious for cancer, pedunculate type polyp, or depressed type polyp. 4.Patients taking steroid, anti platelet, multiple anticoaglants. 5.Non-correctable coagulopathy 6.Pregnancy or lactating 7.Psychiatric disorder 8.Active infection 9.Non-correctable hypertention 10.Chronic respiratory failure 11.Undergo artificial dialysis 12.Inappropriate to participate to the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Procedure related immediate and delayed bleeding rate.
Secondary Outcome Measures
NameTimeMethod
Hematochezia rate (not requiring endoscopic hemostasis), Immediate bleeding rate, Mean procedure time, Mean hospitalization (for subcentimetric polyp, for all polyps), Number of total colonoscopy for clean colon, Adverse event.
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