Disposable Sheathed Gastroscopic System for Cecal Intubation

Study Overview
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Brief Summary
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A novel disposable sheathed gastroscope system has been shown to be safe and more efficient in clinical practice during gastroscopy. This novel disposable sheathed endoscope system could effectively prevent cross-infection by simply taking off the contaminated sheath after examination of a patient and placing a new sheath on the endoscope. In this way, investigators can save the endoscopic reprocessing time and also decrease the need for endoscopic cleaning and disinfecting equipment. Participants may think that placing a new sheath on the endoscope can decrease the success rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on the endoscope during scope insertion can probably increases distension of the colonic lumen and loop formation. The probable adhesion may increase the discomfort of investigators and participants. But a previous clinical study by investigators' team showed that the participants' feeling were no significant difference (Z = -1.783, P = 0.075) between sheathed and conventional groups. No significant differences were observed in optical clarity, or pathology detection rate. There were no complications, and no microbial contamination was detected. Based on this study, investigators hypothesize that compared with conventional group, placing a new sheath on the endoscope does not significantly reduce the success rate of cecal intubation in average patients. The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the endoscope versus the conventional method in average participants. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.

Official Title
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A Novel Disposable Sheathed Gastroscopic System for Cecal Intubation：Safety and Efficacy in Unsedated Colonoscopies

Conditions
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Cecal Intubation Success Rate

Intervention / Treatment
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* Device: A novel disposable sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients accepted sedated colonoscopy Exclusion Criteria: a request for sedation/analgesia at the start of the procedure previous colorectal surgery declining to provide informed consent advanced comorbidity coagulopathy or anticoagulant medication administered failure to comply with the recommended bowel preparation regimen.

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sheathed group<br>The sterilized disposable sheath covered the outer surface of the colonoscope, then colonoscope will be performed in conventional way;a new sheath will be placed on the endoscope in sheathed group as a intervention | Device: A novel disposable sheath<br>* a new sheath will be placed on the endoscope in sheathed group<br>|
| No Intervention: conventional group<br>Colonoscopy will be performed with air insufflation during insertion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation success rate |  | up to ten months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain according to a 10-point pain scale |  | up to ten months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disposable sheath, colonoscopy, intubation