An Integrated Management Pathway for Complex Colorectal Polyps
NCT ID: NCT04576780
Last Updated: 2020-11-17
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
400 participants
OBSERVATIONAL
2021-01-31
2024-01-31
Brief Summary
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Detailed Description
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The primary aim of our study will be to track the outcomes of the new standard-of-care clinical pathway. Clinical objectives of the project include a reduction in wait times for expert assessment after diagnosis of a large or otherwise concerning polyp combined with reduced wait times for therapeutic removal of these polyps, minimizing unnecessary surgery for benign lesions, and facilitating early recommendation for surgery in those patients who truly require surgical resection. Additional objectives include the achievement of excellent rates of clinical success, complication rates similar to those reported in the literature, and high levels of satisfaction from referring doctors at participating centers. A final, major goal is to assess whether this pilot program could serve as a model to be expanded to other academic, tertiary referral centers throughout the province of Ontario.
Our primary research question seeks to compare the diagnostic accuracy of expert polyp adjudication between the different modes of referral (video clip, color photograph, faxed images) against the real-time endoscopic diagnosis during therapeutic colonoscopy and the final pathologic result. The secondary research question is to follow the clinical outcomes of all patients who undergo endoscopic mucosal resection (EMR) of a large or complex colorectal polyp to evaluate the efficacy and safety of this procedure at our expert tertiary referral center.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Referred Patients with Large, Complex Colorectal Polyps
Patients referred from outside community care hospitals or ambulatory endoscopy centers to the therapeutic endoscopy group at St. Michaels Hospital via the new integrated management pathway for endoscopic resection of a large or complex colorectal polyp.
Integrated Large Complex Polyp Referral Pathway
The referring doctor will use a standardized template to send the referral along with its associated video or high-resolution photographs.
Referrals will be reviewed in a consensus fashion by at least 2 expert physicians at St. Michael's Hospital (SMH) on a bi-weekly basis. Polyps will be scored using a standardized evaluation form that documents relevant polyp features to assist the determination of whether a lesion is amenable to curative endoscopic resection.
Cases will be triaged as being: (1) a standard polyp suitable for local removal in the community; (2) a complex polyp requiring expert removal at SMH with priority assigned based on the suspected risk of invasive disease; (3) a polyp that is not amenable to endoscopic resection or that is suspicious for cancer will that be recommended for surgical resection.
Interventions
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Integrated Large Complex Polyp Referral Pathway
The referring doctor will use a standardized template to send the referral along with its associated video or high-resolution photographs.
Referrals will be reviewed in a consensus fashion by at least 2 expert physicians at St. Michael's Hospital (SMH) on a bi-weekly basis. Polyps will be scored using a standardized evaluation form that documents relevant polyp features to assist the determination of whether a lesion is amenable to curative endoscopic resection.
Cases will be triaged as being: (1) a standard polyp suitable for local removal in the community; (2) a complex polyp requiring expert removal at SMH with priority assigned based on the suspected risk of invasive disease; (3) a polyp that is not amenable to endoscopic resection or that is suspicious for cancer will that be recommended for surgical resection.
Eligibility Criteria
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Inclusion Criteria
* Large or complex colorectal polyp found during diagnostic colonoscopy
Exclusion Criteria
* Inability to provide informed consent
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Christopher Teshima, MD
Role: PRINCIPAL_INVESTIGATOR
St. Michaels Hospital
Central Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CTO - 1899
Identifier Type: -
Identifier Source: org_study_id