Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy
Primary Purpose
Adenoma, Pain
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Water colonoscopy
Sponsored by
About this trial
This is an interventional screening trial for Adenoma focused on measuring colonoscopy, water, female, BMI, unsedated, low BMI female patients, Intubation
Eligibility 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
Sites / Locations
- Endoscopic center, Xijing Hospital of Digestive Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Air colonoscopy
Water colonoscopy
Arm Description
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.
Outcomes
Primary Outcome Measures
Cecal intubation success rate
Insertion of a colonoscope to the cecum
Secondary Outcome Measures
Adenoma detection rate
The proportion of participants with at least one adenoma in each group
Pain Scores on the Visual Analog Scale
0 = no pain, to 10 = most severe pain
Cecum intubation time
Total time of colonoscope intubation from anus to cecum
Full Information
NCT ID
NCT01546259
First Posted
February 24, 2012
Last Updated
March 24, 2016
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT01546259
Brief Title
Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy
Official Title
Water Method With Water Exchange Versus Air Insufflation in Low-BMI Female Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Pain
Keywords
colonoscopy, water, female, BMI, unsedated, low BMI female patients, Intubation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Air colonoscopy
Arm Type
No Intervention
Arm Description
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Arm Title
Water colonoscopy
Arm Type
Other
Arm Description
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.
Intervention Type
Other
Intervention Name(s)
Water colonoscopy
Other Intervention Name(s)
Water, colonoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cecal intubation success rate
Description
Insertion of a colonoscope to the cecum
Time Frame
up to two years
Secondary Outcome Measure Information:
Title
Adenoma detection rate
Description
The proportion of participants with at least one adenoma in each group
Time Frame
up to two years
Title
Pain Scores on the Visual Analog Scale
Description
0 = no pain, to 10 = most severe pain
Time Frame
up to two years
Title
Cecum intubation time
Description
Total time of colonoscope intubation from anus to cecum
Time Frame
up to two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, MD
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopic center, Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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Water Method in Low-body Mass Index (BMI) Female Patients With Unsedated Colonoscopy
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