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"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797393
First Posted: February 22, 2013
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University
February 20, 2013
February 22, 2013
February 25, 2013
February 2013
April 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01797393 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • VAS abdominal pain score [ Time Frame: 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. ]
  • 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. ]
  • 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. ]
  • General data of the patients recruited-age [ Time Frame: Data collected usually within 10minutes post procedure . ]
  • General data of the patients recruited-gender [ Time Frame: Data collected usually within 10minutes post procedure . ]
  • General data of the patients recruited-BMI [ Time Frame: 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 . ]
  • General data of the patients recruited-bowel preparation [ Time Frame: Data collected usually within 10minutes post procedure . ]
  • The McGill pain evaluation of the abdominal pain [ Time Frame: Data collected usually within 10minutes post procedure ]
Same as current
Not Provided
Not Provided
 
"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists
"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists
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.
In order to further develop water skills and apply the water assisted colonoscopy technique more flexibly, the investigators designed this study.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Colon Disease;
  • Rectal Disease
  • Other: Air insufflation
    Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
  • Other: Water injection
    Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum .
  • 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.
  • 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.
    Intervention: Other: Air insufflation
  • 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.
    Intervention: Other: Water injection
  • 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.
    Intervention: Other: " Air assisted" water injection.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
600
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01797393
WIC-001
Yes
Not Provided
Not Provided
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Harbin Medical University
Not Provided
Principal Investigator: Youlin Yang, M.D. Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Harbin Medical University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP