Prospective Study of Colon Serrated Polyps

NCT02332785 | Recruiting

• 1 other identifier: PA14-0879
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Data Collection OTHER

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

Composite Data Collection of Endoscopy of Serrated Polyps

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants undergoing colonoscopy at MD Anderson Cancer Center in Houston, Texas.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Colonic Polyps

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gottumukkala S. Raju, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gottumukkala S. Raju, MD

CONTACT

713-563-4377; GSRaju@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 7, 2015
• Study Start: November 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

US (1)