Usefulness of A Scope Guide Assisted Colonoscopy Versus Conventional Colonoscopy

Not Applicable

Completed

• Conditions: Colonoscopy, Colorectal
• Interventions: Procedure: Standard procedure for colonoscopy; Procedure: Scope Guide Assist

• Registration Number: NCT02739893
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Status Verified: 2019-02
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard procedure for colonoscopy	Colonoscopy completed using current SOC without scopeguide assist.
Scope Guide Assisted	Scope Guide Assist	Scope Guide Assist to be utilized during colonoscopy

Primary Outcome Measures

Name	Time	Method
Mean number of mechanical loops required to complete procedure for each arm	from start of colonoscopy until completion - approximately 60 minutes	Each mechanical loop will be counted as 1 (one)
Number of mean external maneuvers per procedure between groups	from start of colonoscopy until completion - approximately 60 minutes	mean number of external maneuvers across all subjects in each arm
Mean cecum intubation time for each arm	from start of colonoscopy until completion - approximately 60 minutes	time in minutes to reach cecum destination in each arm
Mean time in minutes to complete colonoscopy	from start of colonoscopy until completion - approximately 60 minutes	Mean time to completion for each arm

Secondary Outcome Measures

Name	Time	Method
Percent of subjects with detectable polyps per arm	from start of colonoscopy until completion - approximately 60 minutes	percent of subjects in each with at least identifiable polyp
Mean amount of sedation per arm	from start of colonoscopy until completion - approximately 60 minutes	amount of sedation in mg per arm

Trial Locations

Locations (1)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States