ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy

NCT01438645 | Completed

• 1 other identifier: ScopeGuide 01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms; Iron Deficiency Anemia; Diarrhea

Keywords

Colonoscopy; Colon cancer screening

Outcome Measures

Primary Outcomes (1)

• Sedation Score

  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.

  1 day (immediate outcome assessment at time of endoscopy procedure)

Secondary Outcomes (4)

• Patient comfort

  1 day (immediate outcome assessment after recovery from endoscopy procedure)

• Time-to-cecum

  1 day (immediate outcome assessment at time of endoscopy procedure)

• Cecal intubation rate

  1 day (immediate outcome assessment at time of endoscopy procedure)

• Ancillary maneuvers to facilitate procedure

  1 day (immediate outcome assessment at time of endoscopy procedure)

Study Arms (2)

ScopeGuide-assisted colonoscopy

EXPERIMENTAL

These patients will undergo colonoscopy with the assistance of the Olympus ScopeGuide system.

Device: Olympus ScopeGuide

Conventional colonoscopy

NO INTERVENTION

These patients will undergo colonoscopy identical to that in the intervention arm, except with endoscopes lacking the ScopeGuide system.

Interventions

Olympus ScopeGuide DEVICE

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.

Also known as: Magnetic endoscopy imaging

ScopeGuide-assisted colonoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Christopher Teshima: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

Location

Related Publications (3)

• Shah SG, Brooker JC, Williams CB, Thapar C, Saunders BP. Effect of magnetic endoscope imaging on colonoscopy performance: a randomised controlled trial. Lancet. 2000 Nov 18;356(9243):1718-22. doi: 10.1016/S0140-6736(00)03205-0.

  PMID: 11095259 BACKGROUND

• Shah SG, Brooker JC, Thapar C, Suzuki N, Williams CB, Saunders BP. Effect of magnetic endoscope imaging on patient tolerance and sedation requirements during colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2002 Jun;55(7):832-7. doi: 10.1067/mge.2002.124097.

  PMID: 12024136 BACKGROUND

• Teshima CW, Zepeda-Gomez S, AlShankiti SH, Sandha GS. Magnetic imaging-assisted colonoscopy vs conventional colonoscopy: a randomized controlled trial. World J Gastroenterol. 2014 Sep 28;20(36):13178-84. doi: 10.3748/wjg.v20.i36.13178.

  PMID: 25278714 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Anemia, Iron-Deficiency; Diarrhea

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher W Teshima, MD FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

CA (1)