Prospective Study of Colon Serrated Polyps

Status Recruiting

Clinical Trial Summary

With this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. The findings will help us define the natural history of colon serrated lesions, develop techniques for endoscopic management of patients with serrated 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.

Clinical Trial Description

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:

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, endoscopic submucosal dissection 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: Complete or incomplete resection, local recurrence, need for surgery, etc.

9. Outcome of colonoscopy: Complications (Bleeding and perforation). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02332785
Study type	Observational
Source	M.D. Anderson Cancer Center
Contact	Gottumukkala S. Raju, MD
Phone	713-563-4377
Email	GSRaju@mdanderson.org
Status	Recruiting
Phase
Start date	November 2014
Completion date	November 2027

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.