"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

February 21, 2013 updated by: First Affiliated Hospital of Harbin Medical University
Up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners,the investigators conduct this study to preform the "air assisted" water injection colonoscopy in experienced endoscopists.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In order to further develop water skills and apply the water assisted colonoscopy technique more flexibly, the investigators designed this study.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The 1st Affiliated Hospital of Harbin Medical University

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnostic colonoscopy;
  • Subjets able to provide informed consent

Exclusion Criteria:

  • Prior partial or complete colectomy;
  • Patients who decline to participate;
  • Patients with poor bowel preparation;
  • Contraindications of the colonoscopy

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Air insufflation colonoscopy
Air insufflation colonoscopy is the conventional colonoscopy,which is inflating air to help searching the bowel cavity while advancing the colonoscope until reaching the cecum.All the patients were examined without sedation during the whole procedure.
Other: Air insufflation
Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
Experimental: Water injection colonoscopy
Water injection colonoscopy : Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the caecum .The mucosa was observed by inflating the bowel with air while withdrawing the colonoscope.All the patients were examined without sedation during the whole procedure.
Other: Water injection
Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum .
Experimental: " Air assisted" water colonoscopy
" Air assisted" water injection colonoscopy: Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the splenic flexure, small amount of air inflating could be given to help searching the cavity until reaching the cecum.All the patients were examined without sedation during the whole procedure.
Other: " Air assisted" water injection.
Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the splenic flexure, small amount of air inflating could be given to help searching the cavity until reaching the cecum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The success rate of the cecal intubation
Time Frame: This will be calculated after the completion of the whole trial,which is about 2 months
This will be calculated after the completion of the whole trial,which is about 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to reach the splenic flexure(min)
Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
VAS abdominal pain score
Time Frame: Data collected usually within 10minutes post procedure
Data collected usually within 10minutes post procedure
The frequency of the colonoscope shortening maneuver while advancing the colonoscope
Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Length of colonoscope at time of cecal intubation(cm)
Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Volume of water used during water colonoscopy(ml)
Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
General data of the patients recruited-age
Time Frame: Data collected usually within 10minutes post procedure .
Data collected usually within 10minutes post procedure .
General data of the patients recruited-gender
Time Frame: Data collected usually within 10minutes post procedure .
Data collected usually within 10minutes post procedure .
General data of the patients recruited-BMI
Time Frame: Data collected usually within 10minutes post procedure .
Data collected usually within 10minutes post procedure .
General data of the patients recruited-abdominal or pelvic surgery history
Time Frame: Data collected usually within 10minutes post procedure .
Data collected usually within 10minutes post procedure .
General data of the patients recruited-bowel preparation
Time Frame: Data collected usually within 10minutes post procedure .
Data collected usually within 10minutes post procedure .
The McGill pain evaluation of the abdominal pain
Time Frame: Data collected usually within 10minutes post procedure
Data collected usually within 10minutes post procedure
The cecal intubation time(min)
Time Frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Harbin Medical University

Investigators

  • Principal Investigator: Youlin Yang, M.D., Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University

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

February 1, 2013

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIC-001

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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