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

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
Patients with a ≥20mm non-pedunculated colon polyp

Exclusion Criteria

Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
Patients with inflammatory bowel disease
Patients who are receiving an emergency colonoscopy
Poor general health (ASA class>3)
Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
Poor bowel preparation
Pregnancy

Arm && Interventions

Group	Intervention	Description
Clip closure + EndoCut	Clip closure	Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.
Clip closure + Coagulation	Clip closure	Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Delayed Bleeding Complications	30 days following a study polyp resection	A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.

Secondary Outcome Measures

Name	Time	Method
The Overall Number of Complications	30 days	Overall complications are defined as an aggregate of all complications that occur at the time of the procedure (immediate complications) or during 30 days of follow-up. They include delayed bleeding complications, perforation, postpolypectomy syndrome, and clinical events that require an ED visit, admission to the hospital, additional testing or an intervention.
Polyp Recurrence Rate	3 months to 5 years	Rate of recurrent polyp at the resection site after complete polyp resection.
Complete Study Polyp Resection Rate	6 months	Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy
The Number of Complications Associated With Clip Use	30 days	Incidence of complications associated with application of clips.