Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

Overview

This study is the evaluation of ultrafine endoscope (with small caliber and turning radius )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in this trial.

Full Title of Study: “Ultrafine Endoscope for Unsedated Colonoscopy is an Effective Method to Reduce Abdominal Pain:a Prospective Randomized Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2014

Detailed Description

The aim of this study is to investigate the advantages of an endoscope with smaller turning radius and softer insert section in reducing patients' abdominal pain in colonoscopy. Transnasal gastroscope was selected in this study , because of its small caliber (5.9mm) and small turning radius . Visual analogue scale(VAS),cecum intubation time and cecum intubation rate were evaluated.

Interventions

  • Device: Ultrafine Endoscope
    • Ultrafine endoscope reaching to the cecum within 15mins is thought to be successful.Water colonoscopy with standard colonoscope will be performed in unsuccessful subjects subsequently.

Arms, Groups and Cohorts

  • Experimental: Ultrafine Endoscope
    • The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases.

Clinical Trial Outcome Measures

Primary Measures

  • VAS abdominal pain scores
    • Time Frame: up to two months
    • VAS abdominal pain scores include pain scores in the insertion phase of splenic flexure,hepatic flexure,and ileocecal junction.(0=no pain and 10=most severe pain imaginable).

Secondary Measures

  • Cecum intubation time
    • Time Frame: up to two months
    • Insertion time from rectum to reach the cecum.
  • The time to reach the splenic flexure
    • Time Frame: up to two months
    • Insertion time from rectum to reach the flexure.
  • The time to reach the hepatic flexure
    • Time Frame: up to two months
    • Insertion time from rectum to hepatic flexure.
  • The success rate of the cecal intubation within 15 minutes
    • Time Frame: up to two months
    • Percentage of successful colonoscopy (insertion of ultrafine endoscope into cecum within 15 minutes).

Participating in This Clinical Trial

Inclusion Criteria

1. Patients diagnostic colonoscopy;

2. Subjects able to provide informed consent

Exclusion Criteria

1. Patients with poor bowel preparation;

2. Contraindications of the colonoscopy;

3. Prior partial or complete colectomy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Youlin Yang ,MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Youlin Yang ,MD, Professor – First Affiliated Hospital of Harbin Medical University
  • Overall Official(s)
    • Youlin Yang, MD, Principal Investigator, Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University

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