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

A Repeated Instruction by Telephone on the Day Before Colonoscopy Improves the Quality of Bowel Preparation and Colonoscopy Procedure : a Prospective Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Adenoma; Ottawa Score
• Intervention / Treatment: Other: telephone education

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.

• Study Type: Interventional
• Enrollment (Actual): 605
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: normal education; 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.
Other: telephone education; A repeated instruction by telephone on the day before colonoscopy was conducted	Other: telephone education; A repeated instruction by telephone on the day before colonoscopy was conducted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cecum intubation time	Total time of colonoscope intubation from anus to cecum	up to 3 months
Withdrawal time	Total time of colonoscope intubation from cecum to anus	up to 3 months
Polyp detection rate	The proportion of participants with at least one polyp in each group	up to 3 months
Compliance rate to instruction	The proportion of participants compliance to instruction of bowel preparation	up to 3 months
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: pan yanglin, MD., Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 24, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: December 1, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: colonoscopy; education; bowel preparation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 20120405-6