Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01438645
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2011-09-14
Brief Title:
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
Sponsor:
Christopher Teshima
Organization:
University of Alberta
Study Overview
Official Title:
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy for Improved Endoscopic Performance and Enhanced Patient Experience
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
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:
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
Detailed Description:
Summary of Research Proposal
Background
Colon and rectal cancer CRC is a leading cause of cancer-related morbidity and mortality in Canada Colonoscopy is the preferred screening modality for CRC and has been shown to decrease the likelihood of developing CRC as well as CRC-related mortality particularly through the detection and removal of potentially pre-cancerous polyps with the aim of preventing colon cancer and for the diagnosis of early stage CRC that is more likely to be treatable and result in long-term survival However recent evidence suggests that colonoscopy has not been as universally protective against CRC as had been previously hoped particularly for proximal cancers located in the right colon Theories as to why this might be the case include speculation about altered biology of cancers that develop in the proximal colon and technical issues relating to the performance of colonoscopy itself In particular one of the problems is incomplete colonoscopy that fails to examine the entire colon to the cecum which may occur in 10-20 of cases Furthermore from a public health standpoint a considerable proportion of the population remain averse to undergoing colonoscopy particularly because of fears of procedure discomfort decreasing the potential impact for overall CRC reduction Thus optimizing the technical performance of colonoscopy and improving its acceptance among patients is important for maximizing the possible benefits to society
One of the most common reasons for incomplete colonoscopy is excessive internal looping of the endoscope This looping has also been shown to be the major cause of patient discomfort during the procedure Experts agree that colonoscopy is most successful at reaching the cecum and most comfortable for patients when the endoscope is kept in a straight position by minimizing loop formation and reducing loops once they have formed Thus identification and reduction of endoscope loops is critically important for the successful and comfortable completion of colonoscopy Over the years several techniques have emerged to overcome loop formation including withdrawal of the endoscope with torque abdominal wall pressure and patient position changes yet these are all done in a trial and error fashion Despite this limitation these maneuvers form the cornerstones of current colonoscopy technique Technological innovations such as smaller caliber pediatric colonoscopes and variable stiffness colonoscopes with adjustable rigidity have been introduced that have had moderate success in diminishing patient discomfort and increasing rates of colonoscopy completion Yet despite these efforts to improve colonoscopy practice the reality is that many procedures are still done poorly An audit of all colonoscopies performed in Winnipeg from 2004 to 2006 demonstrated a dismal completion rate of only 65 Thus something more clearly needs to be done In an effort to help improve colonoscopy from both the technical standpoint of the endoscopist and also the comfort level of patients Olympus has redesigned a previously developed real-time imaging system that enables visualization of the shape of the entire endoscope while it is inside the patients body This technology called ScopeGuide Olympus America Center Valley PA consists of electromagnetic coils embedded within the endoscope that are detected by an external receiver dish generating a 3D representation of the endoscope that is displayed on a monitor It is anticipated that by visualizing the entire scope as it moves through the body endoscopists will gain useful visual information about loop formation and scope position that will enable greater technical success while creating a more comfortable patient experience
Study Objectives
The purpose of this project is to perform a randomized non-blinded colonoscopy study to determine if real time visualization of the colonoscope using the new Olympus ScopeGuide system is superior to conventional colonoscopy for the achievement of endoscopic procedural outcomes and for an improved patient experience in terms of reduced discomfort and decreased sedation requirements
Methods
Consecutive patients referred for colonoscopy at the University of Alberta Hospital UAH will be considered for study enrollment Eligible patients who meet the inclusion and exclusion criteria and who provide informed consent will be randomized to undergo conventional colonoscopy or colonoscopy with the assistance of the ScopeGuide system The control group will use Olympus CF-H180AL variable-stiffness high-definition colonoscopes that do not differ from the usual procedure and the investigational group will use Olympus CF-H180DL variable-stiffness high-definition 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 patients body as it moves through the colon
The colonoscopy will be performed as clinically indicated either with or without the aid of the ScopeGuide system All patients will undergo a purgative bowel preparation followed by an overnight fast prior to their colonoscopy according to standard clinical practice at UAH At the start of the colonoscopy all patients will initially be given standardized doses of conscious sedation medications consisting of midazolam 2 mg IV and fentanyl 25 mcg IV However the procedure may be initiated without any sedation upon patient request Additional doses of sedative medications may be given at patient request or when the nurse or physician believes that the patient is uncomfortable In all cases the endoscopist will attempt to minimize the formation of loops within the colon and will straighten those loops whenever possible This will be achieved by conventional methods that rely on feel and instinct in the control group and will be directed by the ScopeGuide visualization in the investigational group The endoscopist may use any technical maneuvers deemed necessary to facilitate completion of the procedure including the application of external abdominal pressure by the nurse the repositioning of the patient or tightening of the variable-stiffness setting of the colonoscope Upon intubation of the cecum the insertion distance of the colonoscope from the anus to the cecal pole will be recorded as a marker of the straightness of the endoscope Any abnormalities detected during colonoscope insertion will be more closely inspected photographed and biopsied during subsequent colonoscope withdrawal Furthermore polyps will also be preferentially removed during colonoscope withdrawal which is the existing standard-of-care Any diagnostic or therapeutic applications that are required during the colonoscopy are permitted as clinically indicated
Relevant demographic and clinical information will be recorded prior to the procedure Additional data regarding procedural metrics technical maneuvers and sedation doses will be recorded during the colonoscopy At the conclusion of the colonoscopy the endoscopist will rate the procedural difficulty as usual or difficult and will also note the procedural diagnosis
After the procedure the patient will be kept in the post-endoscopy recovery area in the usual fashion Prior to discharge home from the recovery area participants will complete a visual analogue scale reflecting their degree of discomfort experienced during the procedure
Background
Colon and rectal cancer CRC is a leading cause of cancer-related morbidity and mortality in Canada Colonoscopy is the preferred screening modality for CRC and has been shown to decrease the likelihood of developing CRC as well as CRC-related mortality particularly through the detection and removal of potentially pre-cancerous polyps with the aim of preventing colon cancer and for the diagnosis of early stage CRC that is more likely to be treatable and result in long-term survival However recent evidence suggests that colonoscopy has not been as universally protective against CRC as had been previously hoped particularly for proximal cancers located in the right colon Theories as to why this might be the case include speculation about altered biology of cancers that develop in the proximal colon and technical issues relating to the performance of colonoscopy itself In particular one of the problems is incomplete colonoscopy that fails to examine the entire colon to the cecum which may occur in 10-20 of cases Furthermore from a public health standpoint a considerable proportion of the population remain averse to undergoing colonoscopy particularly because of fears of procedure discomfort decreasing the potential impact for overall CRC reduction Thus optimizing the technical performance of colonoscopy and improving its acceptance among patients is important for maximizing the possible benefits to society
One of the most common reasons for incomplete colonoscopy is excessive internal looping of the endoscope This looping has also been shown to be the major cause of patient discomfort during the procedure Experts agree that colonoscopy is most successful at reaching the cecum and most comfortable for patients when the endoscope is kept in a straight position by minimizing loop formation and reducing loops once they have formed Thus identification and reduction of endoscope loops is critically important for the successful and comfortable completion of colonoscopy Over the years several techniques have emerged to overcome loop formation including withdrawal of the endoscope with torque abdominal wall pressure and patient position changes yet these are all done in a trial and error fashion Despite this limitation these maneuvers form the cornerstones of current colonoscopy technique Technological innovations such as smaller caliber pediatric colonoscopes and variable stiffness colonoscopes with adjustable rigidity have been introduced that have had moderate success in diminishing patient discomfort and increasing rates of colonoscopy completion Yet despite these efforts to improve colonoscopy practice the reality is that many procedures are still done poorly An audit of all colonoscopies performed in Winnipeg from 2004 to 2006 demonstrated a dismal completion rate of only 65 Thus something more clearly needs to be done In an effort to help improve colonoscopy from both the technical standpoint of the endoscopist and also the comfort level of patients Olympus has redesigned a previously developed real-time imaging system that enables visualization of the shape of the entire endoscope while it is inside the patients body This technology called ScopeGuide Olympus America Center Valley PA consists of electromagnetic coils embedded within the endoscope that are detected by an external receiver dish generating a 3D representation of the endoscope that is displayed on a monitor It is anticipated that by visualizing the entire scope as it moves through the body endoscopists will gain useful visual information about loop formation and scope position that will enable greater technical success while creating a more comfortable patient experience
Study Objectives
The purpose of this project is to perform a randomized non-blinded colonoscopy study to determine if real time visualization of the colonoscope using the new Olympus ScopeGuide system is superior to conventional colonoscopy for the achievement of endoscopic procedural outcomes and for an improved patient experience in terms of reduced discomfort and decreased sedation requirements
Methods
Consecutive patients referred for colonoscopy at the University of Alberta Hospital UAH will be considered for study enrollment Eligible patients who meet the inclusion and exclusion criteria and who provide informed consent will be randomized to undergo conventional colonoscopy or colonoscopy with the assistance of the ScopeGuide system The control group will use Olympus CF-H180AL variable-stiffness high-definition colonoscopes that do not differ from the usual procedure and the investigational group will use Olympus CF-H180DL variable-stiffness high-definition 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 patients body as it moves through the colon
The colonoscopy will be performed as clinically indicated either with or without the aid of the ScopeGuide system All patients will undergo a purgative bowel preparation followed by an overnight fast prior to their colonoscopy according to standard clinical practice at UAH At the start of the colonoscopy all patients will initially be given standardized doses of conscious sedation medications consisting of midazolam 2 mg IV and fentanyl 25 mcg IV However the procedure may be initiated without any sedation upon patient request Additional doses of sedative medications may be given at patient request or when the nurse or physician believes that the patient is uncomfortable In all cases the endoscopist will attempt to minimize the formation of loops within the colon and will straighten those loops whenever possible This will be achieved by conventional methods that rely on feel and instinct in the control group and will be directed by the ScopeGuide visualization in the investigational group The endoscopist may use any technical maneuvers deemed necessary to facilitate completion of the procedure including the application of external abdominal pressure by the nurse the repositioning of the patient or tightening of the variable-stiffness setting of the colonoscope Upon intubation of the cecum the insertion distance of the colonoscope from the anus to the cecal pole will be recorded as a marker of the straightness of the endoscope Any abnormalities detected during colonoscope insertion will be more closely inspected photographed and biopsied during subsequent colonoscope withdrawal Furthermore polyps will also be preferentially removed during colonoscope withdrawal which is the existing standard-of-care Any diagnostic or therapeutic applications that are required during the colonoscopy are permitted as clinically indicated
Relevant demographic and clinical information will be recorded prior to the procedure Additional data regarding procedural metrics technical maneuvers and sedation doses will be recorded during the colonoscopy At the conclusion of the colonoscopy the endoscopist will rate the procedural difficulty as usual or difficult and will also note the procedural diagnosis
After the procedure the patient will be kept in the post-endoscopy recovery area in the usual fashion Prior to discharge home from the recovery area participants will complete a visual analogue scale reflecting their degree of discomfort experienced during the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None