Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps

Last updated: April 20, 2023
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polyps

Treatment

N/A

Clinical Study ID

NCT05825664
001
  • Ages > 18
  • All Genders

Study Summary

A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years
  • Non-pedunculated polyps of 10 mm or more in size
  • Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification
  • Patients must sign an informed consent form prior to registration in study

Exclusion

Exclusion Criteria:

  • Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign)
  • Type 3 according to NICE classification
  • Colorectal cancer
  • Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure,kidney failure, liver failure, chronic obstructive pulmonary disease)
  • Hemostasis disorder (INR > 1.5; platelets < 100000/mm3)

Study Design

Total Participants: 228
Study Start date:
April 07, 2023
Estimated Completion Date:
July 31, 2024

Study Description

  • Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center.

  • Randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Conventional endoscopic mucosal resection (CEMR).

  • The time of local recurrence assessment depends on the histopathology of polyps. Polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months.

  • Collecting variables which consist of primary and secodary outcomes.

Connect with a study center

  • University of Medicine and Pharmacy at Ho Chi Minh city

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.