Disposable Sheathed Gastroscopic System for Cecal Intubation

NCT02495480 | Unknown

• 1 other identifier: GHBeijing
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Keywords

disposable sheath; intubation; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Cecal intubation success rate

  up to ten months

Secondary Outcomes (1)

• Pain according to a 10-point pain scale

  up to ten months

Study Arms (2)

sheathed group

EXPERIMENTAL

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

conventional group

NO INTERVENTION

Colonoscopy will be performed with air insufflation during insertion

Interventions

A novel disposable sheath DEVICE

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

sheathed group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients accepted sedated colonoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuqi He: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 13, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 13, 2015

Record last verified: 2015-07