We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose
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.

Condition Intervention
Colon Disease Rectal Disease Pain Other: Air insufflation Other: Water injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

Resource links provided by NLM:


Further study details as provided by Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 . ]

Estimated Enrollment: 300
Study Start Date: February 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 .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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762735


Contacts
Contact: Youlin Yang, M.D. 8613604809322 dr.yangylin@163.com
Contact: Xiaobing Wang, Master 8613936135056 wxbangel@sina.com

Locations
China, Heilongjiang
The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Youlin Yang, M.D.    8613604809322    dr.yangylin@163.com   
Contact: Xiaobing Wang, Master    8613936135056    wxbangel@sina.com   
Principal Investigator: Youlin Yang, M.D.         
Sponsors and Collaborators
Youlin Yang ,MD
Investigators
Principal Investigator: Youlin Yang, M.D. The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
  More Information

Responsible Party: Youlin Yang ,MD, Professor, First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT01762735     History of Changes
Other Study ID Numbers: WIC-002
First Submitted: January 3, 2013
First Posted: January 8, 2013
Last Update Posted: February 12, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Rectal Diseases
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases