Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

Not Applicable

• Conditions: Colon Disease; Rectal Disease
• Interventions: Device: Ultrafine Endoscope

• Registration Number: NCT02160210
• Lead Sponsor: Youlin Yang ,MD

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.

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-06
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Study First Posted: 2014-06-10
• Last Update Posted: 2014-06-10
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrafine Endoscope	Ultrafine Endoscope	The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases.

Primary Outcome Measures

Name	Time	Method
VAS abdominal pain scores	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 Outcome Measures

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

Trial Locations

Locations (1)

The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China