Back to resultsUltrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases
Primary Purpose
Colon Disease;, Rectal Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultrafine Endoscope
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Disease;
Eligibility Criteria
Inclusion Criteria:
- Patients diagnostic colonoscopy;
- Subjects able to provide informed consent
Exclusion Criteria:
- Patients with poor bowel preparation;
- Contraindications of the colonoscopy;
- Prior partial or complete colectomy
Sites / Locations
- The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrafine Endoscope
Arm Description
The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases.
Outcomes
Primary Outcome Measures
VAS abdominal pain scores
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 Outcome Measures
Cecum intubation time
Insertion time from rectum to reach the cecum.
The time to reach the splenic flexure
Insertion time from rectum to reach the flexure.
The time to reach the hepatic flexure
Insertion time from rectum to hepatic flexure.
The success rate of the cecal intubation within 15 minutes
Percentage of successful colonoscopy (insertion of ultrafine endoscope into cecum within 15 minutes).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02160210
Brief Title
Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases
Official Title
Ultrafine Endoscope for Unsedated Colonoscopy is an Effective Method to Reduce Abdominal Pain:a Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Youlin Yang ,MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Disease;, Rectal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrafine Endoscope
Arm Type
Experimental
Arm Description
The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases.
Intervention Type
Device
Intervention Name(s)
Ultrafine Endoscope
Other Intervention Name(s)
Transnasal gastroscope
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS abdominal pain scores
Description
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).
Time Frame
up to two months
Secondary Outcome Measure Information:
Title
Cecum intubation time
Description
Insertion time from rectum to reach the cecum.
Time Frame
up to two months
Title
The time to reach the splenic flexure
Description
Insertion time from rectum to reach the flexure.
Time Frame
up to two months
Title
The time to reach the hepatic flexure
Description
Insertion time from rectum to hepatic flexure.
Time Frame
up to two months
Title
The success rate of the cecal intubation within 15 minutes
Description
Percentage of successful colonoscopy (insertion of ultrafine endoscope into cecum within 15 minutes).
Time Frame
up to two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients diagnostic colonoscopy;
Subjects able to provide informed consent
Exclusion Criteria:
Patients with poor bowel preparation;
Contraindications of the colonoscopy;
Prior partial or complete colectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youlin Yang, MD
Organizational Affiliation
Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases
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