Clinical trial NCT02332785: Prospective Study of Colon Serrated Polyps
Official title: Prospective Study of Colon Serrated Polyps
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colon Polyps
Keywords: Colon Serrated Polyps
Serrated polyp
Hyperplastic polyps above sigmoid colon
Sessile serrated adenoma
Traditional serrated adenoma
Colonoscopy
Endoscopy
Data collection
Data review
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants undergoing colonoscopy at MD Anderson Cancer Center in Houston, Texas.

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

N/A

Primary outcomes:
measure: Data Review of Colonoscopic Resection of Serrated Colon Polyps
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gottumukkala S. Raju, MD
role: PRINCIPAL_INVESTIGATOR
References: