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Left-colon WEC May Reduce Insertion Time Compared With Whole-colon WEC.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01735266
First received: November 23, 2012
Last updated: September 11, 2013
Last verified: September 2013

November 23, 2012
September 11, 2013
May 2013
August 2013   (final data collection date for primary outcome measure)
Cecum intubation time [ Time Frame: up to three months ] [ Designated as safety issue: No ]
Insertion time from rectum to reach the cecum.
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).
Complete list of historical versions of study NCT01735266 on ClinicalTrials.gov Archive Site
  • Pain scores [ Time Frame: up to two months ] [ Designated as safety issue: No ]

    Pain scores include mean pain score and maximal pain score.

    Mean pain score: mean value of patient reported pain score during the insertion phase in three part of colon by using the visual analog pain scale (0=no pain and 10=most severe pain imaginable).

    Maximal pain score: maximal value of patient reported pain score during the insertion phase in three part of colon 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.
  • Total procedure time [ Time Frame: up to two months ] [ Designated as safety issue: No ]
    Total time of colonoscopic procedure.
  • Cecal intubation rate [ Time Frame: up to two months ] [ Designated as safety issue: No ]
    Percentage of successful colonoscopy (insertion of colonoscope into cecum).
  • Withdrawal time [ Time Frame: up to two month ] [ Designated as safety issue: No ]
    Withdrawal time is defined as the time from withdrawal of the colonoscope from the cecum to anal verge. (This time is measured independent of any therapeutic maneuvers, such as biopsy or polypectomy.)
  • Patients willingness to repeat colonoscopy using same method [ Time Frame: up to two month ] [ Designated as safety issue: No ]
    When after the colonoscopic examination, patients were asked if they have willingness to repeat the colonoscopy using same method.
  • Procedure difficulty evaluated by endoscopist [ Time Frame: up to two month ] [ Designated as safety issue: No ]

    When after the colonoscopy, endoscopist were asked to score on the difficulty of the colonoscopic procedure.

    0-very easy, 10-very difficult

  • 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.
Not Provided
Not Provided
 
Left-colon WEC May Reduce Insertion Time Compared With Whole-colon WEC.
Comparative Efficacy of Whole-colon Water Exchange, Left-colon Water Exchange and Air Methods of Colonoscopy on Cecum Intubation in Unsedated Outpatients - - - a Prospective, Randomized Controlled Trail

In most of situation, left colon (especially SD junction) is considered the most difficult part of colonoscopy, where endoscopist may encounter difficulty for scope insertion and patients may feel pain or uncomfortable. It is suggested more than half of the whole time for scope insertion should be used in left colon. Many methods, such as water immersion, abdominal palpation, have been used to facilitate insertion in left colon.

Colonoscopy with whole-colon water exchange method has been shown to be useful for reducing medication used, pain experienced during colonoscopy, increasing the success rate of cecum intubation and adenoma detection rate in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes loop formation and prevents lengthening and distension of the colon during colonoscopy. This will facilitate the colonoscopy in average or difficult colonoscopy. However, it is not known whether the benefits of water exchange method of colonoscopy was mainly due to its effect on the left colon.

We hypothesized that left-colon water exchange colonoscopy (LWE) may have the similar effect regarding the maximal pain score and mean pain score in unsedated patients compared with whole-colon water exchange colonoscopy (WWE). At the mean time, LWE may reduce the insertion time compared with WWE. Here we performed a prospective, randomized controlled study to investigate the efficacies of whole-colon water exchange, left-colon water exchange and air methods of colonoscopy on pain score and insertion time in unsedated outpatients.

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 with conventional air insufflation during colonoscope insertion.
    Other Name: Air colonoscopy
  • Other: Water exchange colonoscopy
    Water exchange method (The air pump was turned off before colonoscopy. During colonoscope insertion, residual air in lumen was suctioned and 37°C water was infused into lumen to obtain lumen visualization) was used in whole or left colon. Air was insufflated until cecum was reached or appendix opening was seen.
    Other Name: Water aided colonoscopy
  • Active Comparator: Air colonoscopy
    Air was insufflated during whole procedure of colonoscope insertion.
    Intervention: Other: Air colonoscopy
  • Experimental: Whole-colon water exchange colonoscopy
    The air pump was turned off before colonoscopy. During the whole procedure of the scope insertion, residual air in lumen was suctioned and 37°C (maintained with a water bath) water was infused with a peristaltic pump to obtain lumen visualization. Air was insufflated until cecum was reached or appendix opening was seen.
    Intervention: Other: Water exchange colonoscopy
  • Experimental: left-colon water exchange colonoscopy
    In the left side of colon (including descending colon, sigmoid colon and rectum), water was infused instead of air to obtain lumen visualization as described above in whole-colon water exchange colonoscopy group.
    Intervention: Other: 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.
 
Completed
300
August 2013
August 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
  • current pregnancy
  • inability to provide informed consent
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
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
September 2013

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