Prospective Study of Colon Serrated Polyps

Colon Polyps Clinical Trial

Official title:

Prospective Study of Colon Serrated Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02332785
• Other study ID #: PA14-0879
• Status: Recruiting
• Start date: November 2014
• Est. completion date: November 2027

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: Gottumukkala S. Raju, MD
• Phone: 713-563-4377
• Email: GSRaju[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: November 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. All Patients with a serrated polyp (Hyperplastic polyps above sigmoid colon, sessile serrated adenoma, traditional serrated adenoma)

Exclusion Criteria:

N/A

Related Conditions & MeSH terms

• Colon Polyps
• Polyps

Intervention

Other:
• Data Collection
Data collection of endoscopy procedure reports of participants with serrated polyps at MD Anderson Cancer Center in Houston, Texas.

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	Data Review of Colonoscopic Resection of Serrated Colon Polyps	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.	1 day

External Links

•   University of Texas MD Anderson Cancer Center Website