Outcome of Colonoscopy Screening and Surveillance

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT01827241

Collaborator

(none)

5,000

Enrollment

Location

135

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroenterology	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:

Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral [EMR])
Comorbid conditions: , cancer and surgical history, medical conditions,
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.
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.
Resection techniques: biopsy, snare resection, endoscopic mucosal resection etc.
Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
Outcomes of colonoscopy: adenoma detections (tubular and villous), cancer and quality metrics.
Outcome of colonoscopy: Complications (Bleeding and performance).

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Outcome of Colonoscopy Screening and Surveillance

Actual Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Polyp Detection in Colon Cancer Screening and Surveillance [9 years]
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.