Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps

April 27, 2025 updated by: Yanqing Li, Shandong University

Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps: a Randomized Controlled Trial

This was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. The primary outcome was delayed postpolypectomy bleeding. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18-80 years old, male and female
  2. Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp

Exclusion Criteria:

  1. Contraindication to colonoscopy or polypectomy
  2. Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy
  3. Alarming signs and symptoms of colorectal cancer (blood in stool, black stool, unexplained anaemia and weight loss, abdominal mass, positive rectal examination; or imaging and laboratory tests highly suspicious for colorectal cancer) or endoscopic manifestations of polyps highly suspicious for high-grade intraepithelial neoplasia or carcinoma
  4. Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding
  5. Inadequate bowel preparation
  6. Pregnant or lactating women
  7. Failure to sign the informed consent form
  8. Patients deemed ineligible by investigators to enrol in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cold snare polypectomy group
Procedure: cold snare polypectomy
Cold snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.
Active Comparator: hot snare polypectomy group
Procedure: hot snare polypectomy
Hot snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delayed postoperative bleeding
Time Frame: interviewed by telephone on days 2 and 14 after polypectomy
bleeding that developed within 2 weeks after the patient left the endoscopy unit
interviewed by telephone on days 2 and 14 after polypectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immediate postpolypectomy bleeding
Time Frame: during the polypectomy
Blood spray or persistent oozing for more than 60 seconds requiring endoscopic intervention
during the polypectomy
procedure time
Time Frame: during the polypectomy
The duration from the appearance of the snare on the monitor to the time when the endoscope was withdrawn from the lesion
during the polypectomy
en bloc resection
Time Frame: during the polypectomy
Removal of a polyp with a single cut and was assessed by the colonoscopist
during the polypectomy
complete histologic resection
Time Frame: during the polypectomy
Clear resection margins, no polyp involvement
during the polypectomy
use of haemostatic clips
Time Frame: during the polypectomy
during the polypectomy
perforation rate
Time Frame: during the polypectomy, and interviewed by telephone on days 2 and 14 after polypectomy
Proportion of patients with intraoperative or postoperative perforation
during the polypectomy, and interviewed by telephone on days 2 and 14 after polypectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 6, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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