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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01584817
First received: April 24, 2012
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Ottawa Score
Adenoma
Other: telephone education

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

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6 [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Total time of colonoscope intubation from anus to cecum

  • Withdrawal time [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Total time of colonoscope intubation from cecum to anus

  • Polyp detection rate [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    The proportion of participants with at least one polyp in each group

  • Compliance rate to instruction [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    The proportion of participants compliance to instruction of bowel preparation

  • Willingness undergo a repeated bowel preparation [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    The number of patients have a willingness to undergo a repeated bowel preparation if needed


Enrollment: 605
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584817

Locations
China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: pan yanglin, MD. Fourth Military Medical University
  More Information

No publications provided by Fourth Military Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01584817     History of Changes
Other Study ID Numbers: 20120405-6
Study First Received: April 24, 2012
Last Updated: December 1, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
colonoscopy
bowel preparation
education

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014