Prospective Study of Colon Serrated Polyps
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|ClinicalTrials.gov Identifier: NCT02332785|
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment|
|Colon Polyps||Other: Data Collection|
Our goal is to collect data from our endoscopy reports and electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025.
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, endoscopic submucosal dissection etc.
- Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
- Outcomes of colonoscopy: Complete or incomplete resection, local recurrence, need for surgery, etc.
- Outcome of colonoscopy: Complications (Bleeding and perforation).
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Prospective Study of Colon Serrated Polyps|
|Actual Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2026|
|Estimated Study Completion Date :||November 2026|
Composite Data Collection of Endoscopy of Serrated Polyps
Goal is to collect data from endoscopy reports & electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025.
Other: Data Collection
Data collection of endoscopy procedure reports of participants with serrated polyps at MD Anderson Cancer Center in Houston, Texas.
- Data Review of Colonoscopic Resection of Serrated Colon Polyps [ Time Frame: 1 day ]
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): NCT02332785
|Contact: Gottumukkala S. Raju, MD||713-563-4377|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: MD Anderson Health Information Specialist 877-632-6789|
|Principal Investigator:||Gottumukkala S. Raju, MD||M.D. Anderson Cancer Center|