NCT00763425

Brief Summary

The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps. Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

September 29, 2008

Last Update Submit

November 17, 2015

Conditions

Colorectal Cancer

Keywords

polypectomycolonic polypcolorectal polypcolorectal cancer prevention

Outcome Measures

Primary Outcomes (1)

  • Complete removal rate of colorectal polyps

    two weeks after each polypectomy

Secondary Outcomes (1)

  • Complication rate

    two weeks after each polypectomy

Study Arms (2)

1

EXPERIMENTAL
Procedure: cold polypectomy

2

ACTIVE COMPARATOR
Procedure: conventional polypectomy

Interventions

cold polypectomyPROCEDURE

The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.

Also known as: cold snare polypectomy
1
conventional polypectomyPROCEDURE

The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.

Also known as: polypectomy
2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women between 20 and 100 years of age

You may not qualify if:

  • Pregnant, American Society of Anesthesiologists class III and IV
  • Overweight (body weight \> 100 kg)
  • Allergic to the drugs used or its components (soybeans or eggs)
  • Poor bowel preparation or post-colorectal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4191, Japan

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Digestive Disease Center

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

JP(1)