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Trial Title:
Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
NCT ID:
NCT05825664
Condition:
Colorectal Polyp
Colorectal Neoplasms
Conditions: Official terms:
Colorectal Neoplasms
Polyps
Conditions: Keywords:
colorectal polyp
underwater endoscopic mucosal resection
conventional endoscopic mucosal resection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic resection
Description:
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
Arm group label:
Conventional endoscopic mucosal resection
Arm group label:
Underwater endoscopic mucosal resection
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
Detailed 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.
Criteria for eligibility:
Criteria:
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 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Medicine and Pharmacy at Ho Chi Minh city
Address:
City:
Ho Chi Minh City
Zip:
700000
Country:
Vietnam
Status:
Recruiting
Contact:
Last name:
Quang D Le, MD
Phone:
+84985938040
Email:
quangledinh@ump.edu.vn
Start date:
April 7, 2023
Completion date:
July 31, 2024
Lead sponsor:
Agency:
University of Medicine and Pharmacy at Ho Chi Minh City
Agency class:
Other
Source:
University of Medicine and Pharmacy at Ho Chi Minh City
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05825664
