NCT02484079

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
429

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

May 18, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 23, 2023

Status Verified

December 1, 2021

Enrollment Period

5 years

First QC Date

April 24, 2015

Last Update Submit

February 22, 2023

Conditions

Colonic PolypsColorectal NeoplasmsAdenoma

Outcome Measures

Primary Outcomes (1)

  • Complete resection rate

    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.

    Hopefully within 4 weeks, when the histopathologist has examined the biopsies

Secondary Outcomes (5)

  • Complications

    4 weeks

  • Factors explaining the primary outcome

    During the hospital stay and up to 4 weeks.

  • Factors explaining the primary outcome

    During the hospital stay and up to 4 weeks

  • Factors explaining the primary outcome

    During the hospital stay and up to 4 weeks

  • Factors explaining the primary outcome

    During the hospital stay and up to 4 weeks

Study Arms (2)

Cold polypectomy

ACTIVE COMPARATOR

Patients in this arm will have their polyps removed by cold polypectomy, i.e. a metal sling that is closed around the basis of the polyp, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely.

Procedure: Polypectomy

Hot polypectomy

ACTIVE COMPARATOR

Patients in this arm will have their polyps removed by hot polypectomy, i.e. a metal sling taht is closed around the basis of the polyp, electrical currents is applied, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely.

Procedure: Polypectomy

Interventions

PolypectomyPROCEDURE
Cold polypectomyHot polypectomy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pedersen IB, Rawa-Golebiewska A, Calderwood AH, Brix LD, Grode LB, Botteri E, Bugajski M, Kaminski MF, Januszewicz W, Odegaard H, Kleist B, Kalager M, Loberg M, Bretthauer M, Hoff G, Medhus A, Holme O. Complete polyp resection with cold snare versus hot snare polypectomy for polyps of 4-9 mm: a randomized controlled trial. Endoscopy. 2022 Oct;54(10):961-969. doi: 10.1055/a-1734-7952. Epub 2022 Jan 10.

    PMID: 35008112DERIVED

MeSH Terms

Conditions

Colonic PolypsColorectal NeoplasmsAdenoma

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

June 29, 2015

Study Start

May 18, 2015

Primary Completion

May 20, 2020

Study Completion

December 31, 2022

Last Updated

February 23, 2023

Record last verified: 2021-12