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Prospective Study of Colonoscopic Resection of Large Polyps and Flat Lesions

Prospective Study of Colonoscopic Resection of Large Polyps and Flat Lesions

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02332772
Enrollment
10000
Registered
2015-01-07
Start date
2015-04-30
Completion date
2025-04-30
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Polyps

Keywords

Colon Polyps, Large polyps, Flat lesions, Endoscopy, Colonoscopic resection, Colonoscopy, Data review, Data collection

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.

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).

Interventions

OTHERData Collection

Data collected from endoscopy procedures.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

N/A

Design outcomes

Primary

MeasureTime frameDescription
Composite Data Review of Colonoscopic Resection of Colon Polyps and Flat Lesions1 dayDescriptive 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.

Countries

United States

Contacts

Primary ContactGottumukkala S. Raju, MD
713-563-4377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026