Disposable Sheathed Gastroscopic System for Cecal Intubation

NCT ID: NCT02495480

Last Updated: 2015-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Cecal Intubation Success Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

sheathed group

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

Group Type: EXPERIMENTAL

A novel disposable sheath

Intervention Type: DEVICE

a new sheath will be placed on the endoscope in sheathed group

conventional group

Colonoscopy will be performed with air insufflation during insertion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

A novel disposable sheath

a new sheath will be placed on the endoscope in sheathed group

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuqi He

OTHER

Sponsor Role: lead

Responsible Party

Yuqi He

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

GHBeijing

Identifier Type: -

Identifier Source: org_study_id