Clinical trial NCT02739893: Usefulness of A Scope Guide Assisted Colonoscopy Versus Conventional Colonoscopy
Official title: Randomized Trial Comparing the Usefulness of A Scope Guide Assisted Colonoscopy Versus Conventional Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy, Colorectal
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to see if use of ScopeGuide, as compared to the traditional colonoscope, improves successful completion of colonoscopy procedures as evaluated by ease of completion, time to completion, and reduction in the number of mechanical loops and external maneuvers required to advance the scope. Other outcome measures include looking at the amount of sedation required (independent of weight) and polyp rate detection.

Detailed description: Currently, the standard practice consists of utilizing a traditional colonoscope and depends on manual manipulation and learned expertise of human anatomy. If the scope guide reduces the amount of external maneuvers required, this will reduce patient discomfort and may reduce sedative requirements during procedure. Reduction in mechanical loops formed while advancing the scope will reduce the amount of time per procedure and potentially increase polyp detection. Additionally, if the physician is unable to complete the procedure (as indicated by reaching the cecum (anatomical structure signifying the end of the colon), clinical data may be lost. A reduction in the number of loops formed and ease of advancing scope will facilitate completion of procedure.

The patient will not be exposed to any inconvenience, danger, or discomfort as a result of study participation. Patients undergoing colonoscopy as SOC, if enrolled into the study, will be randomized by envelope at the time of procedure. If the patient is randomized to the scope guide, the PI simply activates the guide through a mechanical button placed on the scope itself. If the patient is randomized to SOC, the physician proceeds with the colonoscopy without activating the scope guide. The same scope is used regardless of randomization result. The physician is able to turn on and off the magnetic function through the touch of a button.

The colonoscopy procedure itself is not dependent upon use of the scope guide. However, the use of the scope guide may assist the physician in performing the procedure with less physical manipulation. Without the use of the ScopeGuide, an endoscopist is able to perform the procedure based off anatomical knowledge and through the use of maneuvers such as changing the patient position and applying external pressure. This study will test if the ScopeGuide decreases the number of maneuvers required for completion. If the number of maneuvers is decreased, it is likely to decrease patient discomfort and decrease the duration of procedure. This study will also test of the ScopeGuide increases completeness of procedure.

300 patients undergoing SOC colonoscopy will be randomized 1:1 to receive traditional colonoscopy or scope guide assisted colonoscopy.

This study will assess if the scope guide assist function improves successful completion of colonoscopy, time to completion, and reduction in the number of mechanical loops and external maneuvers required to advance the scope. Polyp detection rate and amount of sedation required will also be assessed.

Eligibility criteria: Inclusion Criteria:

* able to safely undergo colonoscopy without history of colorectal surgery, colonic stricture or obstruction.

Exclusion Criteria:

* history of colorectal surgery,
* current colonic stricture or obstruction,
* unable to safely undergo colonoscopy.

Primary outcomes:
measure: Mean cecum intubation time for each arm
timeFrame: from start of colonoscopy until completion - approximately 60 minutes
measure: Mean time in minutes to complete colonoscopy
timeFrame: from start of colonoscopy until completion - approximately 60 minutes
measure: Mean number of mechanical loops required to complete procedure for each arm
timeFrame: from start of colonoscopy until completion - approximately 60 minutes
measure: Number of mean external maneuvers per procedure between groups
timeFrame: from start of colonoscopy until completion - approximately 60 minutes
Secondary outcomes:
measure: Mean amount of sedation per arm
timeFrame: from start of colonoscopy until completion - approximately 60 minutes
measure: Percent of subjects with detectable polyps per arm
timeFrame: from start of colonoscopy until completion - approximately 60 minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
References: