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

November 23, 2012
November 27, 2012
October 2012
October 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01735266 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Segmental Water Exchange Method in Patients With Unsedated Colonoscopy
Water Exchange Colonoscopy Versus Air Colonoscopy for Unsedated Patients: a Prospective Randomized, Controlled, Patient-blind Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
  • Polyp
  • Pain
  • 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
  • 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
  • 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
  • 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.
    Intervention: Other: 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.
    Intervention: Other: Total water exchange 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.
    Intervention: Other: Segmental colonic water exchange colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
282
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Hui Luo 86-29-84771536 fmmulh@163.com
China
 
NCT01735266
20121108-5
Yes
Yanglin Pan, Fourth Military Medical University
Fourth Military Medical University
Not Provided
Principal Investigator: Yanglin Pan, M.D. Fourth Military Medical University
Fourth Military Medical University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP