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Prospective Study of Colon Serrated Polyps

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ClinicalTrials.gov Identifier: NCT02332785
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Colon Polyps Other: Data Collection

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).

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prospective Study of Colon Serrated Polyps
Actual Study Start Date : November 2014
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Data Review of Colonoscopic Resection of Serrated Colon Polyps [ Time Frame: 1 day ]

    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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants undergoing colonoscopy at MD Anderson Cancer Center in Houston, Texas.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332785


Contacts
Contact: Gottumukkala S. Raju, MD 713-563-4377

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: MD Anderson Health Information Specialist    877-632-6789      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Gottumukkala S. Raju, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02332785     History of Changes
Other Study ID Numbers: PA14-0879
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Colon Serrated Polyps
Serrated polyp
Hyperplastic polyps above sigmoid colon
Sessile serrated adenoma
Traditional serrated adenoma
Colonoscopy
Endoscopy
Data collection
Data review

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical