NCT04576780

An Integrated Management Pathway for Complex Colorectal Polyps

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polyp Colorectal

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-01
• Completion: 2024-01-01
• First posted: 2020-10-06
• Last updated: 2020-11-17