Skip to main content
OpenTrials
Completed

NCT Number: NCT02484079

Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps

This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial.

It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.

Completed

Looking for future studies?

Notify Me

Key information

About this study

In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current).

In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines.

The study is designed as a non-inferiority trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatient colonoscopy
  • Signed, written informed consent
  • At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy

Exclusion criteria

  • Implanted cardiac electro converter
  • Severe comorbidity (NYHA 3-4)
  • Known coagulopathy (INR > 1,8) or resent use of any of the new oral anti-coagulant medications
  • Platelet count < 100
  • Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose < 5 days before the procedure)
  • Previous biopsy or attempt of polypectomy of the polyp considered for inclusion in the trial

Treatment and study plan

polypectomy

Procedure

Primary outcomes

  1. Complete resection rate

    Time frame: Hopefully within 4 weeks, when the histopathologist has examined the biopsies

    We want to measure the rate of polyps that are resected completely, both with biopsies from the margin and the histopathologists evaluation of the resection margins of the polyp itself.

Secondary outcomes

  1. Complications

    Time frame: 4 weeks

    We want to register early (during the procedure) and late (within 4 weeks after the procedure) complications.

    Complications we will record is bleeding/blood in the stool, perforation and patient contact with health care provider

  2. Factors explaining the primary outcome

    Time frame: During the hospital stay and up to 4 weeks.

    Patient characteristics

  3. Factors explaining the primary outcome

    Time frame: During the hospital stay and up to 4 weeks

    Doctor characteristics

  4. Factors explaining the primary outcome

    Time frame: During the hospital stay and up to 4 weeks

    Procedure characteristics

  5. Factors explaining the primary outcome

    Time frame: During the hospital stay and up to 4 weeks

    Histology of polyps, correlation between resection margins and biopsies, correlation between optical and histopathological diagnosis

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial

Acronym: HOT/COLD

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
Jun 29, 2015
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.