Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Disease;, Rectal Disease

Intervention / Treatment
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* Device: Ultrafine Endoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrafine Endoscope<br>The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases. | Device: Ultrafine Endoscope<br>* 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.<br>* Other names: Transnasal gastroscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | up to two months | 

Secondary Outcome Measures

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