NCT02132455

Brief Summary

The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer. The doctor performing the procedure will first advance the colonoscope to the end of the colon (cecum) and then he will examine the colon for polyps while he is withdrawing the colonoscope. The period of time that the doctor spent examining the colon called "withdrawal time". Usually doctors will spend at least 6 minutes examining the colon after he reached the cecum. The investigators are proposing that dedicating half of the withdrawal time during colonoscopy in examining the right side of the colon, will increase the detection of polyps in the right side of the colon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

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

January 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

January 2, 2014

Last Update Submit

May 10, 2017

Conditions

Colonoscopy

Keywords

Screening colonoscopySurveillance colonoscopy

Outcome Measures

Primary Outcomes (2)

  • Polyp detection rate (PDR) and Adenoma detection rate (ADR) of patients undergoing a screening colonoscopy either with segmental withdrawal protocol or with non-segmental withdrawal protocol.

    Compare polyp detection rate (PDR) and ADR between patients undergoing a screening colonoscopy with segmental withdrawal protocol and with non-segmental withdrawal protocol.

    30 minutes

  • The Polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 6-minutes or 8-minutes protocols of the segmental withdrawal.

    Compare PDR and ADR between patients undergoing a screening colonoscopy with at least 6-minutes protocol versus at least 8-minutes protocol within each segmental and non-segmental withdrawal protocol.

    30 minutes

Secondary Outcomes (2)

  • The polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 3-minutes or 4-minutes protocols of the non segmental withdrawal

    30 minutes

  • Complication rate

    1 month

Study Arms (4)

3 minutes in the right side colon

EXPERIMENTAL

Colonoscopy, at least 3 minutes in the right side colon from the total withdrawal time

Procedure: colonoscopy

4 minutes in the right side colon

EXPERIMENTAL

Colonoscopy, at least 4 minutes in the right side colon from the total withdrawal time

Procedure: colonoscopy

6 minutes whole withdrawal time

NO INTERVENTION

Colonoscopy, at least 6 minutes whole withdrawal time regardless of time spent in any segment

8 minutes whole withdrawal time

EXPERIMENTAL

Colonoscopy, at least 8 minutes whole withdrawal time regardless of time spent in any segment

Procedure: colonoscopy

Interventions

colonoscopyPROCEDURE

colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer

3 minutes in the right side colon4 minutes in the right side colon8 minutes whole withdrawal time

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults undergoing colonoscopy for screening or surveillance purposes

You may not qualify if:

  • prior history of colonic surgeries
  • Crohn's colitis or ulcerative colitis
  • prior history of colon cancer
  • poor bowel preparation
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Science Center El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Marc Zuckerman, MD

    Texas Tech University Health Science Center El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2014

First Posted

May 7, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)