Prospective Study of Colonoscopic Resection of Large Polyps and Flat Lesions

With this study, the investigators plan to review the performance of colonoscopic resection of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role of colonoscopic resection of colon polyps and flat 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.

Study Overview

• Status: Recruiting
• Conditions: Colon Polyps
• Intervention / Treatment: Other: Data Collection

Detailed Description

Our goal is to collect data from our endoscopy reports (Endoscopy Clinic database) and electronic medical record system (Clinic Station) to complete a descriptive analysis of the 1) demographics, 2) colonoscopy resection procedure, and 3) outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 01/01/2014 - 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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Gottumukkala S. Raju, MD; Phone Number: 713-563-4377

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing endoscopy at MD Anderson Cancer Center in Houston, Texas

Description

Inclusion Criteria:

1. All Patients who have been referred for endoscopic resection of large polyps (>1 cm) and flat lesions.

Exclusion Criteria:

N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Data Collection Endoscopy of Colon Polyps; Data collected from endoscopy reports and electronic medical record system to complete a descriptive analysis of the 1) demographics, 2) colonoscopy resection procedure, and 3) outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 01/01/2014 - 12/31/2025.	Other: Data Collection; Data collected from endoscopy procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Data Review of Colonoscopic Resection of Colon Polyps and Flat Lesions	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Gottumukkala S. Raju, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: January 2, 2015
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Endoscopy; Colonoscopy; Colon Polyps; Data collection; Data review; Large polyps; Flat lesions; Colonoscopic resection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: PA14-0866

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No