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
  Purpose

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.


Condition Intervention
Polyp
Pain
Other: Air colonoscopy
Other: 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: 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

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Cecum intubation time [ Time Frame: up to three months ] [ Designated as safety issue: No ]
    Insertion time from rectum to reach the cecum.


Secondary Outcome Measures:
  • 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



Enrollment: 300
Study Start Date: May 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Air colonoscopy
Air was insufflated during whole procedure of colonoscope insertion.
Other: Air colonoscopy
Colonoscopy will be performed with conventional air insufflation during colonoscope insertion.
Other Name: 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.
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
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.
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

  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
  • current pregnancy
  • inability to provide informed consent
  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: NCT01735266

Locations
China, Shanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shanxi, China, 710032
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: September 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
Colonoscopy

ClinicalTrials.gov processed this record on October 21, 2014