NCT01925833

Brief Summary

Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. \<1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon is in different conformation during insertion and withdrawal phases. We think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

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

August 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

August 16, 2013

Last Update Submit

February 9, 2019

Conditions

Adenoma of Large Intestine

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    4 weeks

Secondary Outcomes (1)

  • Number of adenoma per patient

    4 weeks

Other Outcomes (1)

  • Polyp miss rate

    4 weeks

Study Arms (2)

Both insertion and withdrawal

EXPERIMENTAL
Procedure: Both insertion and withdrawal

Only withdrawal

ACTIVE COMPARATOR
Procedure: Only withdrawal

Interventions

Both insertion and withdrawalPROCEDURE

inspection and polypectomy during both insertion and withdrawal of colonoscopy

Both insertion and withdrawal
Only withdrawalPROCEDURE

inspection and polypectomy during only withdrawal of colonoscopy

Only withdrawal

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing screening or surveillance colonoscopy

You may not qualify if:

  • Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gweon TG, Lee SW, Ji JS, Lee JR, Kim JS, Kim BW, Choi H. Comparison of adenoma detection by colonoscopy between polypectomy performed during both insertion and withdrawal versus during withdrawal only: a multicenter, randomized, controlled trial. Surg Endosc. 2020 Dec;34(12):5461-5468. doi: 10.1007/s00464-019-07342-4. Epub 2020 Jan 17.

    PMID: 31953727DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 16, 2013

First Posted

August 20, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

February 12, 2019

Record last verified: 2019-02