NCT02332772

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

10 years

First QC Date

January 2, 2015

Last Update Submit

May 10, 2019

Conditions

Keywords

Colon PolypsLarge polypsFlat lesionsEndoscopyColonoscopic resectionColonoscopyData reviewData collection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Data collected from endoscopy procedures.

Data Collection Endoscopy of Colon Polyps

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Colonic Polyps

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gottumukkala S. Raju, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gottumukkala S. Raju, MD

CONTACT

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

April 1, 2015

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations