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Spots Global Cancer Trial Database for Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

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Trial Identification

Brief Title: Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

Official Title: Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

Study ID: NCT01936948

Conditions

Colon Polyps

Interventions

Clip closure

Study Description

Brief Summary: The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.

Detailed Description: Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between: * A) Closing the mucosal defect after resection (Clip group) and * B) Not closing the mucosal defect after resection (No clip group). Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings: * A) Low power coagulation and * B) Endocut.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

White River Junction VAMC, White River Junction, Vermont, United States

Contact Details

Name: Heiko Pohl

Affiliation: White River Junction VAMC, Geisel School of Medicine at Dartmouth

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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