Trial record 4 of 1166 for:    Open Studies | "Colonic Diseases"

Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by First Affiliated Hospital of Harbin Medical University
Sponsor:
Information provided by (Responsible Party):
Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01762735
First received: January 3, 2013
Last updated: February 10, 2013
Last verified: February 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • VAS abdominal pain score [ Time Frame: Data collected usually within 10minutes post procedure ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • General data of the patients recruited-age [ Time Frame: Data collected usually within 10minutes post procedure . ] [ Designated as safety issue: No ]
  • General data of the patients recruited-gender [ Time Frame: Data collected usually within 10minutes post procedure . ] [ Designated as safety issue: No ]
  • General data of the patients recruited-BMI [ Time Frame: Data collected usually within 10minutes post procedure . ] [ Designated as safety issue: No ]
  • General data of the patients recruited-abdominal or pelvic surgery history [ Time Frame: Data collected usually within 10minutes post procedure . ] [ Designated as safety issue: No ]
  • General data of the patients recruited-bowel preparation [ Time Frame: Data collected usually within 10minutes post procedure . ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 3, 2013
Last Updated: February 10, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014