Status:

COMPLETED

Clinical Study to Compare Cold Snare Underwater Polypectomy to Cold Snare Conventional Polypectomy for Colon Polyps [COLDWATER Study]

Lead Sponsor:

National and Kapodistrian University of Athens

Conditions:

Colon Polyps

Polypectomy

Eligibility:

All Genders

20+ years

Phase:

NA

Brief Summary

Colon cancer is internationally the third cause of deaths from a malignant disease. Screening colonoscopy in adults \>45 years of age aims at the early diagnosis and treatment colon polyps that are pr...

Eligibility Criteria

Inclusion

  • Age \> 20years
  • Non pedunculated polyps (Paris classification Isp, Is, IIa, IIb)
  • Polyp size: diameter of 5 to 10mm
  • Endoscopic diagnosis of mucosal lesions - must not present malignant submucosal infiltration evidence like deepening, ulceration / ulcer, abnormal vessels, irregular surface, (NICE 1, NICE 2A, BASIC)
  • Informed consent
  • Patients who receive antiplatelet / anticoagulant therapy are included in the study only if their therapy has been modified according to ESGE guidelines

Exclusion

  • Age \<20 years old
  • Pedunculated polyps
  • Lesions with macroscopic elements of high-grade dysplasia or submucosal infiltration
  • Sites with previous polypectomy
  • Patients with idiopathic inflammatory bowel disease
  • Patients with coagulation disorders
  • Patients with severe organ failure
  • Patients who during endoscopy will undergo any technique using electrocautery / electrocoagulation will not be eligible for participation in the study.

Key Trial Info

Start Date :

March 21 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 15 2023

Estimated Enrollment :

396 Patients enrolled

Trial Details

Trial ID

NCT05273697

Start Date

March 21 2022

End Date

July 15 2023

Last Update

November 24 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Sismanogleio General Hospital

Athens, Greece, 15126