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

Not Applicable

Recruiting

• Conditions: Colorectal Polyp; Colorectal Neoplasms

• Registration Number: NCT05825664
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Brief 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.

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-07
• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
en bloc resection	immediately after the procedure	Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more
Curative rate	through study completion, an average of 6 months	Curative rate for non-pedunculated colorectal polyps of 10 mm or more

Secondary Outcome Measures

Name	Time	Method
Complication rate	up to 2 weeks	Rate of complications including bleeding, perforation
Procedure time	during the procedure	Time for complete resection of polyps
Local recurrence rate	6 months	Rate of local recurrence

Trial Locations

Locations (1)

University of Medicine and Pharmacy at Ho Chi Minh city; 🇻🇳 Ho Chi Minh City, Vietnam