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Clinical Trials/NCT04576780
NCT04576780
Unknown
Not Applicable

An Integrated Strategy for the Expedited Diagnosis, Referral, Assessment and Treatment of Complex Colorectal Polyps

Unity Health Toronto0 sites400 target enrollmentJanuary 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polyp Colorectal
Sponsor
Unity Health Toronto
Enrollment
400
Primary Endpoint
Diagnostic accuracy of remote polyp diagnosis (based on video clips, electronic color photographs or paper-based images) compared to real-time endoscopic diagnosis during therapeutic colonoscopy
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the impact of implementing an integrated clinical care pathway for the diagnosis, referral, evaluation and treatment of large complex colorectal polyps on clinical outcomes

Detailed Description

Our project will create a system that links community hospitals and ambulatory endoscopy centers throughout the province of Ontario, directly to the expert endoscopists at our tertiary referral center, to facilitate the timely assessment of polyps based on an electronic referral containing endoscopic video recordings or high-resolution images rather than a paper report through a centralized referral pathway. This polyp adjudication will happen in a timely fashion without involving in-person patient consultation, and will streamline the management of these patients to either referral for surgery or booking for endoscopic polyp removal by therapeutic colonoscopy at our center. Specific endoscopy time slots will be reserved for these patients to ensure they have efficient access to their treatment. This system represents a new care model for managing patients with concerning pre-cancerous lesions diagnosed in disparate local hospitals through a centralized process of referral, diagnostic evaluation and treatment at an expert tertiary referral centre. 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.

Registry
clinicaltrials.gov
Start Date
January 2021
End Date
January 2024
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patient 18 years or older
  • Large or complex colorectal polyp found during diagnostic colonoscopy

Exclusion Criteria

  • Severe medical comorbidities that contraindicate safe endoscopy procedures
  • Inability to provide informed consent

Outcomes

Primary Outcomes

Diagnostic accuracy of remote polyp diagnosis (based on video clips, electronic color photographs or paper-based images) compared to real-time endoscopic diagnosis during therapeutic colonoscopy

Time Frame: During Procedure

Determination of diagnostic accuracy (reported as sensitivity and specificity) of video-based vs. real-time endoscopic diagnosis of polyps; diagnostic accuracy of electronic color photo-based vs. real-time endoscopic diagnosis of polyps; diagnostic accuracy of paper-based images vs. real-time endoscopic diagnosis of polyps.

Secondary Outcomes

  • Patient Wait Times(During Procedure)
  • Prediction of Polyp Diagnosis(Until availability of histology, generally up to 2 weeks post procedure)
  • Residual/Recurrent Polyp(6 months)
  • Need for adjunctive removal(During Procedure)
  • Procedural complications(Up to 4 weeks)
  • Prediction of Successful Endoscopic Treatment(Through study completion, up to 1 year)
  • Referring Physician Satisfaction(1 year)

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