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NCT01950117 Clinical Trial

Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy

Colorectal Polyps Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01950117
Other study ID # EMR vs. polypectomy
Secondary ID
Status Completed
Phase N/A
First received September 21, 2013
Last updated November 2, 2014
Start date September 2013
Est. completion date October 2014

Study information
Verified date November 2014
Source Showa Inan General Hospital
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Recently, it was reported that the incomplete resection rate of neoplastic large polyps after conventional polypectomy was markedly high in clinical practice. The incomplete resection rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.

The aim of this study is to compare the incomplete resection rate of neoplastic large polyps after EMR or conventional polypectomy. The EMR technique is preferable to conventional polypectomy for the complete resection of the large polyps (>15 mm in diameter)

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- Inclusion criteria were nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter.

Exclusion Criteria:

- less than 20 years old, history of previous colorectal surgical resection, American Society of Anesthesiologists class III and IV, allergic to propofol used or its components (soybeans or eggs), or poor bowel preparation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic mucosal resection
Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected after submucosal injection of saline solution before removal.
• Conventional polypectomy
Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected using conventional polypectomy. Submucosal injection of saline solution before removal was not performed.

Locations
Country Name City State
Japan Showa Inan General Hospital Komagane Nagano

Sponsors (1)
Lead Sponsor Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Other the procedure time One day No
Primary The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination. Two weeks No
Secondary Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy Two weeks Yes
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