A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy
Primary Purpose
Ottawa Score, Adenoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
telephone education
Sponsored by
About this trial
This is an interventional screening trial for Ottawa Score focused on measuring colonoscopy, bowel preparation, education
Eligibility Criteria
Inclusion Criteria:
- patients undergoing colonoscopy
Exclusion Criteria:
- disturbance of water and electrolyte
- history of colorectal surgery
- severe colonic stricture or obstructing tumor
- known or suspected bowel obstruction or perforation
- toxic colitis or megacolon
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction or ileus
- severe chronic renal failure (creatinine clearance <30 mL/minute)
- severe congestive heart failure (New York Heart Association class III or IV)
- uncontrolled hypertension (average systolic blood pressure >170 mm Hg, average diastolic blood pressure >100 mm Hg)
- pregnant or lactating women
- patients who cannot give informed consent
Sites / Locations
- Endoscopic center, Xijing Hospital of Digestive Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
normal education
telephone education
Arm Description
patients in this arm was educated about bowel preparation on the day of reservation by nurse for 15 minutes and meanwhile a booklet was also sent to them.
A repeated instruction by telephone on the day before colonoscopy was conducted
Outcomes
Primary Outcome Measures
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
Ottawa score:A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2
The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons; (3) incomplete colonoscopy.
Secondary Outcome Measures
Cecum intubation time
Total time of colonoscope intubation from anus to cecum
Withdrawal time
Total time of colonoscope intubation from cecum to anus
Polyp detection rate
The proportion of participants with at least one polyp in each group
Compliance rate to instruction
The proportion of participants compliance to instruction of bowel preparation
Willingness undergo a repeated bowel preparation
The number of patients have a willingness to undergo a repeated bowel preparation if needed
Full Information
NCT ID
NCT01584817
First Posted
April 24, 2012
Last Updated
December 1, 2013
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT01584817
Brief Title
A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy
Official Title
A Repeated Instruction by Telephone on the Day Before Colonoscopy Improves the Quality of Bowel Preparation and Colonoscopy Procedure : a Prospective Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
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
Cell phone retell the instruction of bowel preparation on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.
Detailed Description
Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the speed, the cecal intubation rate, and the number of polyps detected. It also increases costs, mostly due to repeated procedures. The quality of bowel cleansing has remained suboptimal even though numerous different products and regimens have been tested and compared in no fewer than six meta-analyses. Therefore, a completely different approach to improve precolonoscopy bowel cleansing is welcome.
There are many factors effect the bowel preparation such as age, cirrhosis diabetes, drug compliance, cerebral infarction, dementia, history of major surgery. 20% of patients with poor bowel preparation were due to bad compliance. Studies found that addressing patient perceptions with an inexpensive and simple booklet based on the Health Belief Model improved preparation quality. We assume that doctor retelling the instruction of bowel preparation by cell phone on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ottawa Score, Adenoma
Keywords
colonoscopy, bowel preparation, education
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
605 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal education
Arm Type
No Intervention
Arm Description
patients in this arm was educated about bowel preparation on the day of reservation by nurse for 15 minutes and meanwhile a booklet was also sent to them.
Arm Title
telephone education
Arm Type
Other
Arm Description
A repeated instruction by telephone on the day before colonoscopy was conducted
Intervention Type
Other
Intervention Name(s)
telephone education
Intervention Description
A repeated instruction by telephone on the day before colonoscopy was conducted
Primary Outcome Measure Information:
Title
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
Description
Ottawa score:A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2
The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons; (3) incomplete colonoscopy.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Cecum intubation time
Description
Total time of colonoscope intubation from anus to cecum
Time Frame
up to 3 months
Title
Withdrawal time
Description
Total time of colonoscope intubation from cecum to anus
Time Frame
up to 3 months
Title
Polyp detection rate
Description
The proportion of participants with at least one polyp in each group
Time Frame
up to 3 months
Title
Compliance rate to instruction
Description
The proportion of participants compliance to instruction of bowel preparation
Time Frame
up to 3 months
Title
Willingness undergo a repeated bowel preparation
Description
The number of patients have a willingness to undergo a repeated bowel preparation if needed
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients undergoing colonoscopy
Exclusion Criteria:
disturbance of water and electrolyte
history of colorectal surgery
severe colonic stricture or obstructing tumor
known or suspected bowel obstruction or perforation
toxic colitis or megacolon
dysphagia
compromised swallowing reflex or mental status
significant gastroparesis or gastric outlet obstruction or ileus
severe chronic renal failure (creatinine clearance <30 mL/minute)
severe congestive heart failure (New York Heart Association class III or IV)
uncontrolled hypertension (average systolic blood pressure >170 mm Hg, average diastolic blood pressure >100 mm Hg)
pregnant or lactating women
patients who cannot give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pan yanglin, 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
Citations:
PubMed Identifier
23503044
Citation
Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.
Results Reference
derived
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A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy
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