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Clinical Trials/ISRCTN14491102
ISRCTN14491102
Active, not recruiting
未知

Colorectal endoscopic mucosal resection and delayed bleeding: a prospective multicentre randomized controlled superiority trial comparing PuraStat® with conventional practice to reduce the risk of delayed bleeding after colorectal endoscopic mucosal resection in high-risk patients

Portsmouth Hospitals NHS Trust0 sites540 target enrollmentJanuary 19, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Colorectal polyps
Sponsor
Portsmouth Hospitals NHS Trust
Enrollment
540
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 19, 2023
End Date
December 8, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Adult (aged 18 years or above at time of recruitment) patients referred for EMR of colorectal polyps
  • 2\. Polyp size: 20 mm or more
  • 3\. Polyp location:
  • 3\.1\. Proximal colon: All non\-pedunculated polyps \=20 mm
  • 3\.2\. Distal colon: All non\-pedunculated polyps \=20 mm and patient is on antiplatelet and/or anticoagulation
  • 4\. Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria

  • 1\. Adenoma with known (histologically confirmed) carcinoma
  • 2\. Coagulopathy (INR \=1\.5, platelets \<50\)
  • 3\. Poor bowel preparation
  • 4\. Patients who, according to Investigator’s opinion, should not be included in the study for any reason, including inability to follow study procedures, e.g. cognitively impaired, debilitated or frail patients

Outcomes

Primary Outcomes

Not specified

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