Detection Of Colonic Polyps In India: Diagnostic Colonoscopy
NCT ID: NCT04512729
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
4000 participants
OBSERVATIONAL
2020-08-04
2020-12-30
Brief Summary
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Detailed Description
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The prevalence of adenoma, utilization of colonoscopy for its detection and subsequent reduction in CRC has been well studied and established in western population. This has led to formulation of national screening colonoscopy programs elsewhere. However, data from Indian subcontinent is scanty. In current study, at a large tertiary care center, we aimed to study prevalence of colonic polyps and adenoma who are undergoing diagnostic colonoscopy using high definition colonoscopy and characterizing with Narrow Band Imaging and to find associated demographic, social, personal and family related risk factors in patients with adenomas.
Methodology:
This will be a prospective, single center, observational study. All subjects referred for diagnostic colonoscopy will be prospectively enrolled.
Enrollment:
All subjects referred for the diagnostic colonoscopy will be enrolled. A member of the research team will approach each subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
Study equipment
Colonoscope:
Olympus HDWL colonoscope will be used to perform colonoscopies. Technical specifications include outer diameter 13.2 mm, instrument channel diameter 3.7 mm, air-water suction channels, field of view 170 degrees, 4-way angulations (180 degrees up and 180 degrees down, 160 degrees right and left), working length, 168 cm.
Colonoscopy procedure and definitions
For all patients, either moderate sedation with intravenous midazolam or conscious sedation with intravenous propofol will be administered in a standard fashion prior to undergoing colonoscopy.
The colonoscope will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope.
The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the "insertion time".
The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time. Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.
All polyps detected will be documented: size, location, and morphology (using the Paris classification - Appendix A and Narrow Band Imaging classification - NICE and JNET). Photo documentation of the polyps will be performed.
Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation, each in a separate jar and labeled accordingly.
The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale. Complications including post colonoscopy pain, perforation or gastrointestinal bleeding (requiring intervention) will be recorded.
Adverse events:
The primary investigator at each site will monitor any adverse events reported to the study staff and determine if it's related to the study procedures including standard colonoscopy at the respective site. All adverse events will be monitored until a satisfactory resolution and will be reported to the local IRB within 5 days of knowledge. A table will be maintained for the adverse events in each arm and in case of any statistically significant adverse even rate in any arm, the primary investigator will make the decision to remove the treatment arm or stop the study. Because the risks of this proposed study are low, this program will not require a Data Safety and Monitoring Board. Instead, the Principal Investigator and clinical Site Investigators performing the endoscopies will be responsible for implementing a detailed Data and Safety Monitoring plan in compliance with the IRB guidelines.
Data integrity and safety:
All paper charts pertaining to the patient will be kept under lock and key in coordinators office away from the endoscopy area. The data will be entered in to a data base weekly after collection of histology reports. The data is password protected and stored on the AIG internal server where it will remain throughout the study. Computers and/or files will be password-protected. Only approved personnel by the IRB will have access to the file storage.
To protect subject confidentiality, each subject will be assigned a case study number. The subject's name is not to appear anywhere on the Case Report Forms (CRF's) or supporting documentation. A study log with the identifiable information will be kept in a separate folder to enable the investigators to assist in any research audit. No procedural data except the date of examination will be entered in to this log.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Colonoscopy
For all patients, either moderate sedation with intravenous midazolam or conscious sedation with intravenous propofol will be administered in a standard fashion prior to undergoing colonoscopy.
The colonoscope will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope.
The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.All polyps detected will be documented: size, location, and morphology. Photo documentation of the polyps will be performed.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Mohan Ramchandani
Principal Investigator
Locations
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D Nageshwar Reddy
Hyderabad, Telangana, India
Countries
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Central Contacts
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Facility Contacts
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References
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Jagtap N, Kalapala R, Rughwani H, Singh AP, Inavolu P, Ramchandani M, Lakhtakia S, Manohar Reddy P, Sekaran A, Tandan M, Nabi Z, Basha J, Gupta R, Memon SF, Venkat Rao G, Sharma P, Nageshwar Reddy D. Application of machine-learning model to optimize colonic adenoma detection in India. Indian J Gastroenterol. 2024 Oct;43(5):995-1001. doi: 10.1007/s12664-024-01530-4. Epub 2024 May 17.
Other Identifiers
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DoCPI
Identifier Type: -
Identifier Source: org_study_id