Outcome of Colonoscopy Screening and Surveillance
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|ClinicalTrials.gov Identifier: NCT01827241|
Recruitment Status : Recruiting
First Posted : April 9, 2013
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment|
|Gastroenterology||Other: Chart Review|
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 Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Outcome of Colonoscopy Screening and Surveillance|
|Actual Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
- Polyp Detection in Colon Cancer Screening and Surveillance [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827241
|Contact: Gottumukkala S. Raju, MD||713-792-5496|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gottumukkala S. Raju, MD||M.D. Anderson Cancer Center|