NCT02538406

Brief Summary

Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. "Withdrawal time" is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

4.8 years

First QC Date

August 31, 2015

Last Update Submit

October 26, 2020

Conditions

Adenomatous Polyp of Colon

Keywords

Adenomawithdrawal timeColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Increase in detection rate of adenomas in the right side of the colon

    To determine if timed segmental withdrawal protocol can increase the adenoma detection rate in the right side of the colon compared to non segmental withdrawal.

    30 minutes

Secondary Outcomes (1)

  • Sessile Serrated lesion detection rate

    30 minutes

Study Arms (2)

non segmental withdrawal

A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon.

Segmental withdrawal

A standard of care colonoscopy will be done on the patient , however the time spent in the right side of the colon will be more than half of the normal colonoscopy procedure (i.e. more than 3 minutes)

Other: Segmental withdrawal

Interventions

Segmental withdrawalOTHER

Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.

Segmental withdrawal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study participants will be recruited from patients ages 18-80 scheduled for a screening colonoscopy at Baylor College of Medicine. Informed consent will be obtained from the patients during their Gastroenterology clinic visit if the procedure scheduled by gastroenterologist or during their pre-procedure assessment appointment if they were referred by a primary care doctor. Participation in the study will be voluntary. We use the split prep protocol in preparation for colonoscopy in all patients undergoing colonoscopy in our unit.

You may qualify if:

  • Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes.

You may not qualify if:

  • Patients with a prior history of colonic surgeries
  • Patient with Crohns colitis or ulcerative colitis
  • Patient with prior history of colon cancer
  • Patient with poor bowel preparation
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Mohamed O. Othman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 2, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2020

Study Completion

April 2, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations

US(1)