Outcome of Colonoscopy Screening and Surveillance

NCT ID: NCT01827241

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2022-12-31

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.

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).

Conditions

Gastroenterology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Chart Review

Intervention Type: OTHER

Retrospective and prospective data review of colonoscopy procedures, examination findings, resection techniques, and pathology reports.

Interventions

Chart Review

Retrospective and prospective data review of colonoscopy procedures, examination findings, resection techniques, and pathology reports.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gottumukkala S. Raju, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gottumukkala S. Raju, MD

Role: CONTACT

GSRaju@mdanderson.org

713-792-5496

References

Raju GS, Lum PJ, Ross WA, Thirumurthi S, Miller E, Lynch PM, Lee JH, Bhutani MS, Shafi MA, Weston BR, Pande M, Bresalier RS, Rashid A, Mishra L, Davila ML, Stroehlein JR. Outcome of EMR as an alternative to surgery in patients with complex colon polyps. Gastrointest Endosc. 2016 Aug;84(2):315-25. doi: 10.1016/j.gie.2016.01.067. Epub 2016 Feb 6.

Reference Type: DERIVED

PMID: 26859866 (View on PubMed)

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

DR11-0264

Identifier Type: -

Identifier Source: org_study_id