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N/A N=57 Randomized Double-blind Diagnostic

Colonoscope Insertion Trial Protocol

Colorectal Cancer

Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Time to Intubate the Cecum — 271; 403 seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Colonoscopy with Olympus Technically Improved Colonoscope (Device); Control with standard colonoscope Olympus CF-H180 (Device)
Age
Adult, Older Adult · 35+ yrs
Sex
All
Sponsor
UConn Health
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Intubate the Cecum
271; 403
PRIMARY
Intubation of Cecum
27; 29 1.00

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.

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01324882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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