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Completed

NCT Number: NCT01324882

Colonoscope Insertion Trial Protocol

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Colonoscopy with Olympus Technically Improved Colonoscope

Device

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

Other names: Olympus Technically improved colonoscope

Control with standard colonoscope Olympus CF-H180

Device

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

Other names: Olympus CF-H180

Primary outcomes

  1. Time to Intubate the Cecum

    Time frame: 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.

    The time in seconds that it required to intubate the cecum as defined in our protocol.

  2. Intubation of Cecum

    Time frame: (day 1) Within time for performance of colonoscopy

    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.

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Registry information

Official study title

Study to Examine Insertion of 2 Colonoscopes Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2011
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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