Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR

Study Overview
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Brief Summary
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This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic mucosal resection with hot endoscopic mucosal resection. Half of the participants will receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic mucosal resection.

Detailed Description
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Colorectal polyps are considered as precancerous lesions and endoscopical resection is currently the treatment of choice when it is possible. Colorectal polyps are classified into diminutive polyps (<5mm in diameter), small polyps (6-9mm in diameter), and large polyps (>1cm in diameter). There are several endoscopical treatment methods: cold biopsy forceps polypectomy, cold snare polypectomy, hot biopsy forceps polypectomy, hot snare polypectomy, and endoscopic mucosal resection. Cold polypectomy means mechanical removal of the polyp with snare or biopsy forceps without the use of electrocautery, and hot polypectomy means removal of the polyp with the use of electocautery.

Official Title
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Comparison of Small Colorectal Polyp Removal Using Cold Endoscopic Mucosal Resection With Hot Endoscopic Mucosal Resection: a Pilot Study

Conditions
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Colonic Polyps

Intervention / Treatment
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* Procedure: Cold endoscopic mucosal resection
* Procedure: Hot endoscopic mucosal resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with colorectal polyps that are <1cm in diameter who need endoscopic mucosal resection. Patients who gave informed consents to this study. Exclusion Criteria: Patients under the age of 19 Patients who are receiving antiplatelet or anticoagulant therapies Patients with hypercoagulability (i.e., liver cirrhosis, hemophilia, end-stage renal disease, or chronic kidney disease)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold EMR group<br>Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare without electrocautery. | Procedure: Cold endoscopic mucosal resection<br>* Cold endoscopic mucosal resection (EMR) means removing small colorectal polyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.<br>|
| Active Comparator: Hot EMR group<br>Patients who have small colorectal polyps (<1cm) who receive endoscopic mucosal resection using snare with the use of electrocautery. | Procedure: Hot endoscopic mucosal resection<br>* Hot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete removal of the colorectal polyp | The resected specimen will be reviewed microscopically to assess complete resection including the lateral and base margins | At the time of the procedure (endoscopic mucosal resection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | The time needed for the hot EMR vs cold EMR (minutes) will be assessed. | At the time of the procedure (endoscopic mucosal resection) | 
| Complication after endoscopic mucosal resection | Procedure-related complications (bleeding, perforation, and post-coagulation syndrome) will be assessed. | Within 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic Polyps, Endoscopic Mucosal Resection, Colonoscopy