Colonoscope Insertion Trial Protocol

Colorectal Cancer Clinical Trial

Official title:

Study to Examine Insertion of 2 Colonoscopes Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324882
• Other study ID #: 10-246-1
• Secondary ID: 1-642-01
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: November 30, 2017
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is about determining how well a Technically Improved Colonoscope from Olympus works in helping the doctor in guiding the scope through the large bowel or colon. When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the appendix where the small bowel ends and the large bowel begins. There are points during this insertion where there are turns in the colon which can create a loop in the colonoscope. These loops can stretch the colon and create some discomfort and also require special maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the looping will make it more comfortable for the patient and more efficient for screening for polyps. The purpose of the study is to examine this colonoscope and compare it to the traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this colonoscope will function better with regard to insertion of the scope from the rectum to the cecum.

Description:

There will be two arms to the study, the CF-H180 adult colonoscope (Control Arm) and the Olympus Technically Improved Colonoscope (Olympus). (Control Arm). In this protocol the investigators will randomize patients to either the adult colonoscope or to the Olympus Technically Improved Colonoscope (Olympus) arm. The name of the arm (CF-H180 adult colonoscope or Technically Improved Colonoscope) will be in a sealed envelope and opened by the nurse. The endoscopist will be blinded to the scope that will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients presenting for outpatient colonoscopy between the ages of 35 and 75 years of age

• The patient population will be open. However, it is known that thin female patients (BMI < 25) and/or past history of diverticular disease and/or gynecological surgery and men & women who are tall (6'+) and patients with constipation are usually difficult candidates for a complete colonoscopy (retroflex in the cecum)

• Adequate bowel preparation

• The ability to provide informed consent

Exclusion Criteria:

• Women that are pregnant

• Patients with a past history of inflammatory bowel disease

• Patients with a past history of surgical resection (hemicolectomies, etc)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• Colonoscopy with Olympus Technically Improved Colonoscope
The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.
• Control with standard colonoscope Olympus CF-H180
Standard colonoscopy using the adult scope, Olympus CF-H180.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Intubate the Cecum	The time in seconds that it required to intubate the cecum as defined in our protocol.	The outcome was measured during the colonoscopy which was Day 1. The duration of the study was the colonoscopy on Day 1. Once the colonoscopy was finished, the study was over.
Primary	Intubation of Cecum	The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.	(day 1) Within time for performance of colonoscopy