Clinical trial NCT04576780: An Integrated Management Pathway for Complex Colorectal Polyps
Official title: An Integrated Strategy for the Expedited Diagnosis, Referral, Assessment and Treatment of Complex Colorectal Polyps
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polyp Colorectal
Keywords: Large Colorectal Polyp
Complex Colorectal Polyp
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who were identified to have a large, complex polyp on colonoscopy at a community hospital or ambulatory endoscopy center referred for removal to the therapeutic endoscopy group at St. Michaels Hospital.

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.

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

Primary outcomes:
measure: 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
timeFrame: During Procedure
Secondary outcomes:
measure: Patient Wait Times
timeFrame: During Procedure
measure: Prediction of Polyp Diagnosis
timeFrame: Until availability of histology, generally up to 2 weeks post procedure
measure: Need for adjunctive removal
timeFrame: During Procedure
measure: Prediction of Successful Endoscopic Treatment
timeFrame: Through study completion, up to 1 year
measure: Procedural complications
timeFrame: Up to 4 weeks
measure: Residual/Recurrent Polyp
timeFrame: 6 months
measure: Referring Physician Satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: St. Michaels Hospital
name: Christopher Teshima, MD
role: PRINCIPAL_INVESTIGATOR
References: