NCT03859479

Brief Summary

A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 20, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

February 28, 2019

Last Update Submit

March 4, 2019

Conditions

Colorectal Polyp

Keywords

Cold snare polypectomyHot snare polypectomyСolorectal polypsEndoscopic treatment

Outcome Measures

Primary Outcomes (2)

  • R0 resection rate

    14 days

  • Complete resection rate

    1 day

Secondary Outcomes (6)

  • Incidence of local recurrence

    6 months

  • The immediate bleeding or immediate perforation rate after polypectomy

    1 day

  • Complication rate

    14 days

  • Use of submucosal injection

    1 day

  • Polyp retrieval rate

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Cold snare polypectomy

EXPERIMENTAL

After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital

Procedure: Cold snare polypectomy

Hot snare polypectomy

ACTIVE COMPARATOR

After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital

Procedure: Hot snare polypectomy

Interventions

Cold snare polypectomyPROCEDURE

After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital

Cold snare polypectomy
Hot snare polypectomyPROCEDURE

After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital

Hot snare polypectomy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non-pedunculated colorectal adenomas who had provided written informed consent

You may not qualify if:

  • known coagulopathy.
  • polyposis of the alimentary tract.
  • inflammatory bowel disease.
  • malignant polyps.
  • associated diseases in the stage of decompensation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 1, 2019

Study Start

January 20, 2019

Primary Completion

August 30, 2021

Study Completion

August 31, 2021

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)