Colonoscope Insertion Trial Protocol

NCT01324882 | Completed Results

• 2 other identifiers: 10-246-11-642-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Study Arms (2)

Study Arm

EXPERIMENTAL

This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.

Device: Colonoscopy with Olympus Technically Improved Colonoscope

Control

ACTIVE COMPARATOR

This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.

Device: Control with standard colonoscope Olympus CF-H180

Interventions

Colonoscopy with Olympus Technically Improved Colonoscope DEVICE

The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.

Also known as: Olympus Technically improved colonoscope

Study Arm

Control with standard colonoscope Olympus CF-H180 DEVICE

Standard colonoscopy using the adult scope, Olympus CF-H180.

Also known as: Olympus CF-H180

Control

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women that are pregnant
• Patients with a past history of inflammatory bowel disease
• Patients with a past history of surgical resection (hemicolectomies, etc)

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Joseph Anderson
• Organization: UConn Health Center

joseph.anderson@dartmouth.edu

8022959362

Study Officials

• Joseph C Anderson, M.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof (Adjunct)

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 29, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 2, 2017
• Results First Posted: August 23, 2013

Record last verified: 2017-11

Locations

US (1)