A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy

Adenoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584817
• Other study ID #: 20120405-6
• Status: Completed
• Phase: N/A
• First received: April 24, 2012
• Last updated: December 1, 2013
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: December 2013
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Adenoma
• Ottawa Score

Intervention

Other:
• telephone education
A repeated instruction by telephone on the day before colonoscopy was conducted

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 months	No
Secondary	Cecum intubation time	Total time of colonoscope intubation from anus to cecum	up to 3 months	No
Secondary	Withdrawal time	Total time of colonoscope intubation from cecum to anus	up to 3 months	No
Secondary	Polyp detection rate	The proportion of participants with at least one polyp in each group	up to 3 months	No
Secondary	Compliance rate to instruction	The proportion of participants compliance to instruction of bowel preparation	up to 3 months	No
Secondary	Willingness undergo a repeated bowel preparation	The number of patients have a willingness to undergo a repeated bowel preparation if needed	up to 3 months	No