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Outcome of Colonoscopy Screening and Surveillance

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ClinicalTrials.gov Identifier: NCT01827241
Recruitment Status : Recruiting
First Posted : April 9, 2013
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
With this study, we plan to review the performance of colonoscopy in colon cancer screening and surveillance, especially with the recent improvements in endoscopic technology (high definition endoscopes), use of split dose preparation which provides excellent colon preparation for detection of lesions and increasing awareness and detection of flat lesions of the colon. The findings will help us define the role of colonoscopy screening 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.

Condition or disease Intervention/treatment
Gastroenterology Other: Chart Review

Detailed Description:

Investigator's goal is to collect data from the endoscopy reports and clinic station reports to complete a descriptive analysis of the demographics, colonoscopy procedure performance, and assess the type of benign colon polyps detected during screening and surveillance from 02/01/2000 - 12/31/2020.

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 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: adenoma detections (tubular and villous), cancer and quality metrics.
  9. Outcome of colonoscopy: Complications (Bleeding and performance).

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome of Colonoscopy Screening and Surveillance
Actual Study Start Date : September 2011
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
Colonoscopy Outcomes
Data collected from endoscopy reports to complete a descriptive analysis of demographics, colonoscopy procedure performance, and assess type of benign colon polyps detected during screening and surveillance from 02/01/2009 - 12/31/2020.
Other: Chart Review
Retrospective and prospective data review of colonoscopy procedures, examination findings, resection techniques, and pathology reports.




Primary Outcome Measures :
  1. Polyp Detection in Colon Cancer Screening and Surveillance [ Time Frame: 9 years ]
    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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Chart review from participants receiving colonoscopy at UT MD Anderson Cancer Center in Houston, Texas from 02/01/2009 - 12/31/2020.
Criteria

Inclusion Criteria:

1. All Patients who have undergone colonoscopy for screening, surveillance or symptom evaluation.

Exclusion Criteria:

1. None


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): NCT01827241


Contacts
Contact: Gottumukkala S. Raju, MD 713-792-5496

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Gottumukkala S. Raju, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01827241     History of Changes
Other Study ID Numbers: DR11-0264
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Gastroenterology
Colonoscopy
Screening
Surveillance
Symptom evaluation
Chart review
Data review
Examination findings
Resection techniques
Pathology reports