The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

NCT01480830 | Completed

• 1 other identifier: NCT01480830
• Study Type: interventional
• Target: 633
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient. This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen. We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.

Conditions

Colonoscopy

Keywords

Quality; indicators

Outcome Measures

Primary Outcomes (1)

• Cecal intubation rate

  baseline

Secondary Outcomes (5)

• Patient comfort

  baseline

• Amount of sedation required

  baseline

• Polyp detection rate

  baseline

• Use of abdominal compression

  baseline

• Insertion time

  baseline

Study Arms (2)

Standard colonoscopy

NO INTERVENTION

Magnetic endoscopic imaging colonoscopy

EXPERIMENTAL

Device: Magnetic Endoscopic Imaging (MEI) colonoscopy

Interventions

Magnetic Endoscopic Imaging (MEI) colonoscopy DEVICE

Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by

Magnetic endoscopic imaging colonoscopy

Eligibility Criteria

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

You may qualify if:

• Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site.

You may not qualify if:

• Inability or unwillingness to provide written informed consent.
• Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide).
• Colonoscopist not participating in trial.
• Current pregnancy.
• Cardiac pacemaker or any other type of implantable stimulator.
• Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Donald MacIntosh, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)