Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
NCT ID: NCT05825664
Last Updated: 2023-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
228 participants
INTERVENTIONAL
2023-04-07
2024-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Underwater endoscopic mucosal resection
Intervention: Non-pedunculated polyps will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3) snaring the lesion and the surrounding mucosa; and (4) resection using electrocautery.
Endoscopic resection
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
Conventional endoscopic mucosal resection
Intervention: Non-pedunculated polyps will be removed by conventional endoscopic mucosal resection. The CEMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection applying the same electrocautery setting as was used for UEMR.
Endoscopic resection
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
Interventions
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Endoscopic resection
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Responsible Party
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Le Dinh Quang
Principal investigator
Locations
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University of Medicine and Pharmacy at Ho Chi Minh city
Ho Chi Minh City, , Vietnam
Countries
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Facility Contacts
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Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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