An Integrated Management Pathway for Complex Colorectal Polyps

NCT04576780 | Unknown

• 1 other identifier: CTO - 1899
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Conditions

Polyp Colorectal

Keywords

Large Colorectal Polyp; Complex Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  During Procedure

Secondary Outcomes (7)

• Patient Wait Times

  During Procedure

• Prediction of Polyp Diagnosis

  Until availability of histology, generally up to 2 weeks post procedure

• Need for adjunctive removal

  During Procedure

• Prediction of Successful Endoscopic Treatment

  Through study completion, up to 1 year

• Procedural complications

  Up to 4 weeks

Study Arms (1)

Referred Patients with Large, Complex Colorectal Polyps

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.

Other: Integrated Large Complex Polyp Referral Pathway

Interventions

Integrated Large Complex Polyp Referral Pathway OTHER

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.

Referred Patients with Large, Complex Colorectal Polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Officials

• Christopher Teshima, MD

  St. Michaels Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Teshima, MD

CONTACT

(416) 864-5646; Christopher.Teshima@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 6, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 17, 2020

Record last verified: 2020-11