Working… Menu
Trial record 65 of 317 for:    colon cancer | ( Map: Canada )

ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438645
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):
Christopher Teshima, University of Alberta

Brief Summary:
Colonoscopy is an established technology that enables doctors to obtain live video from inside patients' large intestines, which is essential for the diagnosis of numerous intestinal illnesses. It consists of a long, flexible tube fitted with a light-source and small video camera that transmits the images onto a display monitor. The doctor inserts the scope into the anus, moves it into the rectum and then guides it slowly through the entire colon. Because of the various twists and turns that are part of normal bowel anatomy, advancing the scope through the entire colon is not always successful and can become challenging when the scope forms loops inside the abdomen. Unfortunately, there is no way for the doctor to see the shape of the scope inside the body other than what is seen from the video at its front end, and so navigating the colon relies on instinct accumulated with experience and the "feel" of the scope as loops begin to form. This is important because not only can this loop formation cause pain, but it can also increase the likelihood of an incomplete test. Incomplete tests matter because a major reason for performing colonoscopy is colon cancer screening and surveillance; detecting early cancers at treatable stages and looking for polyps that may be pre-cancerous growths. When colonoscopy does not advance through the entire colon, parts are left unexamined where cancer may develop. A new technology called "ScopeGuide" has been developed that uses magnetic coils embedded within the scope to create a 3D image of the shape of the entire scope inside the body that is projected onto the monitor for the doctor to see. This will show if loops are forming and will provide information about how to eliminate loops once they have formed. In this research study, the investigators will compare colonoscopy with the assistance of ScopeGuide to colonoscopy performed in the standard fashion, to see if ScopeGuide results in more successful procedures that are easier for the doctor and more comfortable for patients.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Iron Deficiency Anemia Diarrhea Device: Olympus ScopeGuide Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy for Improved Endoscopic Performance and Enhanced Patient Experience
Study Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ScopeGuide-assisted colonoscopy
These patients will undergo colonoscopy with the assistance of the Olympus ScopeGuide system.
Device: Olympus ScopeGuide
ScopeGuide-assisted colonoscopy using Olympus CF-H180DL variable-stiffness colonoscopes equipped with ScopeGuide capabilities. ScopeGuide will provide the endoscopist with a 3-dimensional image on the monitor depicting the shape of the colonoscope inside the patient's body as it moves through the colon.
Other Name: Magnetic endoscopy imaging

No Intervention: Conventional colonoscopy
These patients will undergo colonoscopy identical to that in the intervention arm, except with endoscopes lacking the ScopeGuide system.

Primary Outcome Measures :
  1. Sedation Score [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]
    The main efficacy parameter is the amount of sedation used during colonoscopy, expressed as the mean for each group. Since our conscious sedation consists of two different drugs, the doses of each will be converted into a numerical score, such that typical 1 mg dose increments of midazolam and 25 mcg increments of fentanyl will each be assigned a score of '1,' and the two will be added together to give the sedation score.

Secondary Outcome Measures :
  1. Patient comfort [ Time Frame: 1 day (immediate outcome assessment after recovery from endoscopy procedure) ]
    Patients wil complete a 10 cm visual analogue pain scale (VAS) that will be converted to a numerical score (0-100) with each number representing 1 mm on the 10 cm VAS from 0 at its left extreme (representing 'no pain') to 100 on its right extreme (representing 'unbearably severe pain'). The mean pain score will then be determined for each of the groups.

  2. Time-to-cecum [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]
    Time from initial insertion of colonoscope until successful intubation of the cecum (min)

  3. Cecal intubation rate [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]
    Proportion of colonoscopy procedures resulting in successful intubation of the cecum.

  4. Ancillary maneuvers to facilitate procedure [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ]
    Number of added maneuvers, including abdominal pressure, repositioning of patient, endoscope loop reduction techniques, used to facilitate advancement of endoscope during procedure.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult patient 18 years or older.
  2. Able to read & write English.
  3. Undergoing colonoscopy at University of Alberta Hospital for any indication.

Exclusion Criteria:

  1. Colonoscopy performed without prior purgative bowel prep.
  2. Patient with active, ongoing lower GI bleeding.
  3. Colonoscopy performed to attempt colonic decompression in acute colonic pseudo-obstruction (Ogilvie's syndrome).
  4. Colonoscopy for which propofol sedation is required.
  5. Inpatient colonoscopy performed by a trainee under staff supervision.
  6. Patient with previous colonic surgery.
  7. Patient with pacemaker or implantable cardioverter-defibrillator (ICD).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438645

Layout table for location information
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Sponsors and Collaborators
Christopher Teshima
Layout table for investigator information
Principal Investigator: Christopher W Teshima, MD FRCPC University of Alberta

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christopher Teshima, Assistant Professor, University of Alberta Identifier: NCT01438645     History of Changes
Other Study ID Numbers: ScopeGuide 01
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013
Keywords provided by Christopher Teshima, University of Alberta:
Colon cancer screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Anemia, Iron-Deficiency
Signs and Symptoms, Digestive
Signs and Symptoms
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases