MedTrace Logo

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

NCT01936948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 928

Last updated 2024-07-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Colon Polyps

Interventions

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.

Sponsors & Collaborators

  • Dartmouth College

    collaborator OTHER

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • White River Junction Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Heiko Pohl · White River Junction VAMC, Geisel School of Medicine at Dartmouth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2018-06-30
Completion
2022-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936948 on ClinicalTrials.gov