- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772250
Bowel Preparation by Face-to-face Re-education on the Day of Colonoscopy for Outpatient: a RCT (FFRE)
Effecacy of Face-to-face Bowel Preparation for Afternoon Colonoscopy: a Randomised Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite advances in bowel preparation methods,bowel preparation is inadequate in up to one-third of all colonoscopies in reported series.Inadequate bowel cleansing results in negative consequences for the examination, including incomplete visualisation of the colon, missed lesions, procedural difficulties, prolonged procedure time and reduced time interval until follow-up, and an estimated 12-22% increase in overall colonoscopy cost.
The adequacy of a bowel preparation is closely linked to patient compliance with both dietary and purge instructions.One study performed in Asia showed that non-compliance with bowel preparation instructions, lower education level, and a long wait for the colonoscopy appointment were independent risk factors for poor bowel preparation. Another study performed in China showed that telephone re-education(TRE) about the details of bowel preparation on the day before colonoscopy significantly improved the quality of bowel preparation and PDR. So,it is reasonable to hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.
The study compares the efficacy of bowel preparation between the face-to-face re-education (FFRE group) and telephone re-education (TRE group) in patients.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Department of Gastroenterology, Qilu Hospital, Shandong University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Outpatients aged 18-80 years undergoing colonoscopy who had provided written informed consent
Exclusion Criteria:
- history of colorectal surgery
- severe colonic stricture or obstructing tumour
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction or ileus
- known or suspected bowel obstruction or perforation
- severe chronic renal failure (creatinine clearance<30 ml/min)
- severe congestive heart failure (New York Heart Association class III or IV)
- uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- toxic colitis or megacolon
- dehydration
- disturbance of electrolytes
- pregnancy or lactation
- unable to give informed consent
- haemodynamically unstable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: telephone re-education(TRE)
Subjects who are randomized into this group receive regular instructions at the time of their appointment to discuss colonoscopy (a nurse provides education of 5 minutes and meanwhilet sent a bookle to the patient) and a TRE which was conducted by a investigator at 15:00-17:00 on the day before colonoscopy.
|
Subjects who are randomized into this group receive regular instructions at the time of their appointment to discuss colonoscopy (a nurse provides education of 5 minutes and meanwhilet sent a bookle to the patient) and a TRE which was conducted by one investigator at 15:00-17:00 on the day before colonoscopy.
|
Experimental: face-to-face re-education (FFRE)
Subjects who are randomized into this group receive regular instructions on the day of their appointment to discuss colonoscopy and also a FFRE which was conducted by a investigator on the same-day of procedure at hospital.
|
Subjects who are randomized into this group receive regular instructions on the day of their appointment to discuss colonoscopy and also a FFRE which was conducted by a investigator on the same-day of procedure at hospital.
|
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 Boston Bowel Preparation Scale rating scores≥6 among 2 groups.
Time Frame: 5 months
|
This is an established rating scale to evaluate the quality of bowel prep.
The ratings will be compared among the 2 groups.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of compliance with instructions among 2 groups
Time Frame: 5 months
|
Compliance was scored on a 3-grade scale based on the intake of bowel solution: 0 = optimal (intake of 100% of the solution); 1 = good (intake of ≥75% of the solution); 2 = poor (intake of <75% of the solution).
|
5 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Willingness to repeat bowel preparation among 2 groups.
Time Frame: 5 months
|
The willingness to repeat the same bowel preparation,a patient's subjective evaluation of the bowel preparation was recorded by a questionnaire
|
5 months
|
Polyp detection rate among 2 groups.
Time Frame: 5 months
|
Polyp detection rate was defined as the proportion of patients with at least one polyp.
|
5 months
|
Withdrawal time among 2 groups.
Time Frame: 5 months
|
Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps.
|
5 months
|
Caecal intubation rate among 2 groups.
Time Frame: 5 months
|
Caecal intubation rate is defined the proportion of patients with caecal intubation.
|
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016SDU-QILU-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bowel Preparation
-
University of British ColumbiaCompletedEfficacy of Bowel Preparation | Ease of Bowel Preparation and Patient TolerabilityCanada
-
Alexandra Hospital, Athens, GreeceRecruitingBowel Preparation | Preparation for ColonoscopyGreece
-
Inje UniversityUnknownBOWEL PREPARATION (BOWEL CLEANSING)Korea, Republic of
-
Jinling Hospital, ChinaRecruiting
-
Ferring PharmaceuticalsRecruitingBowel PreparationUnited States
-
Taejoon Pharmaceutical Co., Ltd.Completed
-
Azienda USL ModenaCompleted
-
Shandong UniversityUnknownBowel PreparationChina
-
Samsung Medical CenterCompletedBowel PreparationKorea, Republic of
Clinical Trials on telephone re-education(TRE)
-
Keimyung University Dongsan Medical CenterCompletedBowel PreparationKorea, Republic of
-
First Affiliated Hospital Xi'an Jiaotong UniversityCompleted
-
Changhai HospitalUnknownAdenoma Detection Rate | Bowel Preparation ScaleChina
-
Universidad de GranadaUnknownChronic Obstructive Pulmonary DiseaseSpain
-
St. Justine's HospitalShriners Hospitals for Children; Laval University; Université de Montréal; CHU...RecruitingAdolescent Idiopathic ScoliosisCanada
-
Teachers College, Columbia UniversityColumbia University; 1199SEIU Benefit and Pension FundsCompletedColorectal Cancer
-
Air Force Military Medical University, ChinaCompletedA Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing ColonoscopyAdenoma | Ottawa ScoreChina
-
Shandong UniversityUnknownHelicobacter Pylori Eradication RateChina
-
US Department of Veterans AffairsCompleted
-
University of ArizonaNational Cancer Institute (NCI)Completed