Colon Disease;, Rectal Disease
Conditions
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.
Interventions
DEVICEUltrafine 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.
Sponsors
Youlin Yang ,MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Outcome results
None listed