Disposable Sheathed Gastroscopic System for Cecal Intubation

July 10, 2015 updated by: Yuqi He

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: A novel disposable sheath
a new sheath will be placed on the endoscope in sheathed group
No Intervention: conventional group
Colonoscopy will be performed with air insufflation during insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cecal intubation success rate
Time Frame: up to ten months
up to ten months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuqi He

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 13, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GHBeijing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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