Clinical trial NCT01584817: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ottawa Score
Adenoma
Keywords: colonoscopy
bowel preparation
education
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
timeFrame: up to 3 months
Secondary outcomes:
measure: Cecum intubation time
timeFrame: up to 3 months
measure: Withdrawal time
timeFrame: up to 3 months
measure: Polyp detection rate
timeFrame: up to 3 months
measure: Compliance rate to instruction
timeFrame: up to 3 months
measure: Willingness undergo a repeated bowel preparation
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: pan yanglin, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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.