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Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01546259
First received: February 24, 2012
Last updated: January 19, 2014
Last verified: May 2013
  Purpose

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Female gender and low-body mass index (BMI) is independently associated with incomplete colonoscopy, respectively. The investigators postulate that low-BMI female patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in low-BMI female patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-BMI female patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Condition Intervention
Adenoma
Pain
Other: Water colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Cecal intubation success rate [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    Insertion of a colonoscope to the cecum


Secondary Outcome Measures:
  • Adenoma detection rate [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    The proportion of participants with at least one adenoma in each group

  • Pain Scores on the Visual Analog Scale [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    0 = no pain, to 10 = most severe pain

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


Estimated Enrollment: 140
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Air colonoscopy
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Water colonoscopy
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.
Other: Water 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 warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.
Other Names:
  • Water
  • colonoscopy

  Eligibility

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

Inclusion Criteria:

  • Female patients with BMI < 20

Exclusion Criteria:

  • History of colorectal surgery
  • Severe colonic stricture or obstructing tumor
  • Patients who cannot give informed consent and those who are hemodynamically unstable
  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: NCT01546259

Locations
China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Yanglin Pan, MD Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01546259     History of Changes
Other Study ID Numbers: 20120216-7
Study First Received: February 24, 2012
Last Updated: January 19, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
colonoscopy
water
female
BMI
unsedated
low BMI female patients
Intubation

ClinicalTrials.gov processed this record on November 20, 2014