An Integrated Management Pathway for Complex Colorectal Polyps

Unity Health Toronto

Status: Unknown

Conditions: Polyp Colorectal

Treatments: Other: Integrated Large Complex Polyp Referral Pathway

Study type: Observational

Funder types: Other

Identifiers

NCT04576780

CTO - 1899

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Referred Patients with Large, Complex Colorectal Polyps

Description:

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.

Treatment:

Other: Integrated Large Complex Polyp Referral Pathway