NCT01936948

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 928 (actual)
• Sponsor: White River Junction Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Polyps

Interventions

Type	Name	Description
PROCEDURE	Clip closure	Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.

Timeline

• Start date: 2013-04-01
• Primary completion: 2018-06-30
• Completion: 2022-10-01
• First posted: 2013-09-06
• Last updated: 2024-07-12
• Results posted: 2021-06-22

Locations

1 site across 1 country: United States