Outcome of Colonoscopy Screening and Surveillance

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.

Study Overview

• Status: Unknown
• Conditions: Gastroenterology
• Intervention / Treatment: Other: Chart Review

Detailed Description

Investigator's goal is to collect data from the endoscopy reports and clinic station reports to complete a descriptive analysis of the demographics, colonoscopy procedure performance, and assess the type of benign colon polyps detected during screening and surveillance from 02/01/2000 - 12/31/2020.

Specific variable to be reviewed:

1. Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
2. Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral [EMR])
3. Comorbid conditions: , cancer and surgical history, medical conditions,
4. Colonoscopy procedure; quality of colon preparation (using the Boston Bowel Preparation Scale) 0 - 3 for each section of the colon (Ascending, Transverse, Descending and Total Colon) , cecal intubation rate, cecal intubation and total procedure time, type of colonoscope (if CO2 was used in the procedure and techniques for colonoscope insertion, including position changes.
5. Examination findings: number of polyps and nature of polyps removed (site, size, surface, vascular pattern); type of polyp removed (serrated and sessile (flat) ; optical features and histology of polyps.
6. Resection techniques: biopsy, snare resection, endoscopic mucosal resection etc.
7. Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
8. Outcomes of colonoscopy: adenoma detections (tubular and villous), cancer and quality metrics.
9. Outcome of colonoscopy: Complications (Bleeding and performance).

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Retrospective and prospective data review of colonoscopy procedures, examination findings, resection techniques, and pathology reports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Gottumukkala S. Raju, MD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Screening; Colonoscopy; Surveillance; Gastroenterology; Chart review; Symptom evaluation; Data review; Examination findings; Resection techniques; Pathology reports
• Other Study ID Numbers: DR11-0264

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No