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Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

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 Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762735
First Posted: January 8, 2013
Last Update Posted: February 12, 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):
Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University
January 3, 2013
January 8, 2013
February 12, 2013
February 2013
March 2013   (Final data collection date for primary outcome measure)
The success rate of the cecal intubation within 15 min(%) [ 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 NCT01762735 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 . ]
Same as current
Not Provided
Not Provided
 
Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.

Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.

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 effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Colon Disease
  • Rectal Disease
  • Pain
  • 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.
  • 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 .All the patients were examined without sedation during the whole procedure.
    Intervention: Other: 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
300
March 2013
March 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
 
 
NCT01762735
WIC-002
Yes
Not Provided
Not Provided
Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University
Youlin Yang ,MD
Not Provided
Principal Investigator: Youlin Yang, M.D. The 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