Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

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):
First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01797393
First received: February 20, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Colon Disease;
Rectal Disease
Other: Air insufflation
Other: Water injection
Other: " Air assisted" 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: "Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

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 [ 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 ]
  • The McGill pain evaluation of the abdominal pain [ Time Frame: Data collected usually within 10minutes post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 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 .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.

Detailed Description:

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

  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: NCT01797393

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

Locations
China, Heilongjiang
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
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
  More Information

No publications provided

Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT01797393     History of Changes
Other Study ID Numbers: WIC-001
Study First Received: February 20, 2013
Last Updated: February 21, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014