Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576780
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-09-15
Brief Title:
An Integrated Management Pathway for Complex Colorectal Polyps
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
An Integrated Strategy for the Expedited Diagnosis Referral Assessment and Treatment of Complex Colorectal Polyps
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None