Effect of Anesthesia on Force Application During Colonoscopy

Completed

• Conditions: Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases
• Interventions: Device: Colonoscopy Force Monitor

• Registration Number: NCT02101099
• Lead Sponsor: Artann Laboratories

Brief Summary

The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.

Detailed Description

Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Male or female
• Age: 30-75 years
• ASA Class I or II
• All ethnic and racial groups will be included

Exclusion Criteria

• Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
• Specific pathology that would limit the extent of examination
• ASA class 3 or greater
• Pregnancy
• Monitored anesthesia using propofol for sedation.
• Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing colonoscopy	Colonoscopy Force Monitor	Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.

Primary Outcome Measures

Name	Time	Method
Peak push force is increased in patients receiving propofol as compared to conscious sedation.	6 months

Trial Locations

Locations (3)

Georgetown University Medical Center, Gastroenterology; 🇺🇸 Washington, District of Columbia, United States

Chevy Chase Endoscopy Center; 🇺🇸 Chevy Chase, Maryland, United States

Univeristy of Pennsylvania Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States