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Segmental Water Exchange Method in Patients With Unsedated Colonoscopy

This study is currently recruiting participants.
Verified November 2012 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01735266
First received: November 23, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

Colonoscopy is widely used for diagnosis and management of colorectal diseases. Conventional colonoscopy with air insufflation may distend, lengthen and distend the colon lead to increased discomfort of patients and difficulty of cecal intubation. The use of water infusion in lieu of air insufflation (water exchange method) obviates excessive lengthening of the colon, and facilitates completion of colonoscopy. Several studies revealed that the total colonic water exchange method can significantly reduce the pain score and enhance the success of cecal intubation in minimal-sedation or unsedated colonoscopy. However, this method was associate with long operation time. Due to the special anatomic structure of sigmoid and descending colon (the left side of the colon), passage through this region is more difficult during colonoscopy. The investigators hypothesized that the critical superiority of water-aided colonoscopy is avoiding of lengthening and looping of sigmoid and descending colon. So, compare with total colonic water exchange method, the segmental colonic water exchange method should get the same effect with less operation time.


Condition Intervention
Polyp
Pain
 Other: Air colonoscopy
Other: Total water exchange colonoscopy
Other: Segmental colonic water exchange colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Water Exchange Colonoscopy Versus Air Colonoscopy for Unsedated Patients: a Prospective Randomized, Controlled, Patient-blind Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Cecal intubation success rate [ Time Frame: up to six months ] [ Designated as safety issue: No ]
    The rate of subjects with complete colonoscopy (insertion of the colonoscope tip into the cecal caput).


Secondary Outcome Measures:
  • Pain Scores [ Time Frame: up to six months ] [ Designated as safety issue: No ]
    The subjects were asked to report the pain score during the insertion phase by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).

  • Polyp detection rate [ Time Frame: up to six months ] [ Designated as safety issue: No ]
    The proportion of subjects with at least one polyp.

  • Cecum intubation time [ Time Frame: up to six months ] [ Designated as safety issue: No ]
    Total time of colonoscope intubation from anus to cecum.


Estimated Enrollment: 282
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Air colonoscopy
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion. A successful cecal intubation was defined as insertion of the colonoscope tip into the cecal caput.
 Other: Air colonoscopy
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion. A successful cecal intubation was defined as insertion of the colonoscope tip into the cecal caput.
Other Name: Air colonoscopy
Experimental: Total water exchange colonoscopy
The air pump was turned off before colonoscopy. Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting 37°C warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecal caput) is reached.
 Other: Total water exchange colonoscopy
The air pump was turned off before colonoscopy. Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting 37°C warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecal caput) is reached.
Other Name: Water aided colonoscopy
Experimental: Segmental colonic water exchange colonoscopy
The air pump was turned off before colonoscopy. Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting 37°C warm sterile water into the colon to open up the colon for advancement of the colonoscope until until the splenic flexure of colon is reached. A successful cecal intubation was defined as insertion of the colonoscope tip into the cecal caput.
 Other: Segmental colonic water exchange colonoscopy
The air pump was turned off before colonoscopy. Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting 37°C warm sterile water into the colon to open up the colon for advancement of the colonoscope until the splenic flexure of colon is reached. A successful cecal intubation was defined as insertion of the colonoscope tip into the cecal caput.
Other Name: Water aided colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with unsedated colonoscopy

Exclusion Criteria:

  • history of colon resection
  • severe colonic stricture or obstructing tumor
  • hemodynamic instability
  • inability to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735266

Contacts
Contact: Hui Luo 86-29-84771536 fmmulh@163.com

Locations
China, Shanxi
Endoscopic center, Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shanxi, China, 710032
Contact: Yanlin Pan, M.D.     86-29-84771536     panyl@fmmu.edu.cn    
Principal Investigator: Yanglin Pan, M.D.            
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Yanglin Pan, M.D. Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01735266     History of Changes
Other Study ID Numbers: 20121108-5
Study First Received: November 23, 2012
Last Updated: November 27, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
Colonoscopy

ClinicalTrials.gov processed this record on May 21, 2013