Bowel Preparation Clinical Trial
Official title:
Improving Effect of Reinforced Family Member Education on the Quality of Bowel Preparation for Colonoscopy
Enhanced instructions such as re-education by telephone or short message which increase the
patient adherence eventually improve the quality of bowel preparation significantly. However,
the effect of family assistance which plays an essential role on compliance of patient with
treatment on bowel preparation is unknown. The investigators hypothesized that reinforced
education giving family members of outpatients will enhance family support to patients for
colonoscopy, and consequently improve the quality of bowel preparation.
Therefore, the investigators designed protocols to reinforce family member education by
verbal (face to face or telephone) and written methods. The aim of this study is to evaluate
the effect of reinforced family member education on patient compliance and the quality of
bowel preparation for colonoscopy. In addition，the rate of side effects happening, the
subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent
risk factors will be also assessed.
Adequate bowel preparation is essential for optimal examination of the colorectal mucosa
during colonoscopy. However, approximately 10%-30% bowel preparation is inadequate, leading
to significantly decrease diagnostic accuracy and surveillance intervals, increase the
procedural difficulties, and even increase the procedure-related complications. As reported,
enhanced instructions such as re-education by telephone or short message which increase the
patient adherence eventually improve the quality of bowel preparation significantly. However,
the effect of family assistance which plays an essential role on compliance of patient with
treatment on bowel preparation is unknown. The investigators hypothesized that reinforced
education giving family members of outpatients will enhance family support to patients for
colonoscopy, and consequently improve the quality of bowel preparation.
Therefore, the investigators designed protocols to reinforce family member education by
verbal (face to face or telephone) and written methods. The aim of this study is to evaluate
the effect of reinforced family member education on patient compliance and the quality of
bowel preparation for colonoscopy. In addition，the rate of side effects happening, the
subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent
risk factors will be also assessed.
This is a prospective, endoscopist-blinded, randomized, controlled study.
1. Patients, Arm Description, Education and Blinding. Consecutive individuals over 18
years, who will be scheduled for undergoing colonoscopy between September and December
2017 at the Endoscopy Center of Wuxi people's Hospital in China and are not accord with
the exclusion criteria will be enrolled in the study. After signature of informed
consent, Patients will be consecutively randomized to either the reinforced family
member education (RFME) or regular education (control) group at the time of colonoscopy
appointments by opening a sealed opaque envelope. Regular instructions will be given to
all patients during the colonoscopy appointment by one experienced endoscopy nurse. For
RFME group, at least one family member who lives with the patient together will be given
instruction at the basis of patent education. The information of group assignments will
be keep from colonoscopists and other investigators at any time.
2. Bowel preparation. Two kinds of purgatives, magnesium sulphate and polyethylene glycol
electrolyte powder (PEG-ELP), are available in our endoscopy center, and the type will
be prescribed by physician based on the conditions of the patient.
3. Data collection and Definitions. On the day of colonoscopy, the patients will be asked
to arrive at the Endoscopy Center 1 h before the procedure. The baseline data, clinical
data and related data of the enrolled patients will be collected 1 h before the
colonosc0py.
4. Colonoscopy. All colonoscopy will be carried out between 13:30 and 16:30 by 5 five
experienced endoscopists. The Boston Bowel Preparation Scale (BBPS) scoring system will
be employed for the assessment of the quality of bowel preparation. The endoscopists
will be asked to give the BBPS score immediately after the colonoscopy, and the findings
of the colonoscopy, the cecal intubation, the insertion time, the withdrawal time and
the incomplete examination cases not for poor bowel preparation will be recorded
simultaneously.
5. Statistical analysis. A total of 276 patients in each group will be required to obtain
statistical significance for the primary outcome. Baseline characteristics, primary and
secondary outcomes will be evaluated by intention-to-treat (ITT) analysis. To assess
independent risk factors associated with inadequate bowel preparation, multivariate
analysis will be conducted using the score of bowel preparation quality (BBPS <5) with a
P value of ≤ 0.10 in the univariate analysis. All analyses will be carried out with SPSS
software V.20.0 (SPSS Inc., Chicago, IL, USA). A P value of <0.05 was considered
statistically significant.
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