Outcome of Colonoscopy Screening and Surveillance

Gastroenterology Clinical Trial

Official title:

Outcome of Colonoscopy Screening and Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01827241
• Other study ID #: DR11-0264
• Status: Recruiting
• Start date: September 2011
• Est. completion date: December 2022

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: Gottumukkala S. Raju, MD
• Phone: 713-792-5496
• Email: GSRaju[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. None

Related Conditions & MeSH terms

• Gastroenterology

Intervention

Other:
• Chart Review
Retrospective and prospective data review of colonoscopy procedures, examination findings, resection techniques, and pathology reports.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website