NCT01827241

Brief Summary

With this study, we plan to review the performance of colonoscopy in colon cancer screening and surveillance, especially with the recent improvements in endoscopic technology (high definition endoscopes), use of split dose preparation which provides excellent colon preparation for detection of lesions and increasing awareness and detection of flat lesions of the colon. The findings will help us define the role of colonoscopy screening of colon polyps and flat lesions and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

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

September 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

10.3 years

First QC Date

April 2, 2013

Last Update Submit

May 14, 2019

Conditions

Keywords

GastroenterologyColonoscopyScreeningSurveillanceSymptom evaluationChart reviewData reviewExamination findingsResection techniquesPathology reports

Outcome Measures

Primary Outcomes (1)

  • Polyp Detection in Colon Cancer Screening and Surveillance

    Descriptive tables presented for demographics, polyp counts, colonoscopy experiences, polyp removals and findings. Proportions presented with 95% confidence intervals. Continuous values such as age and times presented with median, minimum and maximum. Comparisons among patient subgroups made with chi-square tests for categorical data and t-tests or the non-parametric alternative, Wilcoxon tests, to compare continuous measures. Graphics such as box plots, trellis plots, bar graphs, or stacked bar graphs used to describe distributions overall and among subgroups.

    9 years

Study Arms (1)

Colonoscopy Outcomes

Data collected from endoscopy reports to complete a descriptive analysis of demographics, colonoscopy procedure performance, and assess type of benign colon polyps detected during screening and surveillance from 02/01/2009 - 12/31/2020.

Other: Chart Review

Interventions

Retrospective and prospective data review of colonoscopy procedures, examination findings, resection techniques, and pathology reports.

Colonoscopy Outcomes

Eligibility Criteria

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

Chart review from participants receiving colonoscopy at UT MD Anderson Cancer Center in Houston, Texas from 02/01/2009 - 12/31/2020.

You may qualify if:

  • \. All Patients who have undergone colonoscopy for screening, surveillance or symptom evaluation.

You may not qualify if:

  • \. None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Raju GS, Lum PJ, Ross WA, Thirumurthi S, Miller E, Lynch PM, Lee JH, Bhutani MS, Shafi MA, Weston BR, Pande M, Bresalier RS, Rashid A, Mishra L, Davila ML, Stroehlein JR. Outcome of EMR as an alternative to surgery in patients with complex colon polyps. Gastrointest Endosc. 2016 Aug;84(2):315-25. doi: 10.1016/j.gie.2016.01.067. Epub 2016 Feb 6.

Related Links

Study Officials

  • Gottumukkala S. Raju, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gottumukkala S. Raju, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 9, 2013

Study Start

September 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations