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Bowel Preparation by Face-to-face Re-education on the Day of Colonoscopy for Outpatient: a RCT (FFRE)

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ClinicalTrials.gov Identifier: NCT02772250
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Tracking Information
First Submitted Date  ICMJE May 7, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date April 10, 2017
Study Start Date  ICMJE May 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 11, 2016)
  • 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
  • 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.
  • Withdrawal time among 2 groups. [ Time Frame: 5 months ]
    Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps.
  • Caecal intubation rate among 2 groups. [ Time Frame: 5 months ]
    Caecal intubation rate is defined the proportion of patients with caecal intubation.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bowel Preparation by Face-to-face Re-education on the Day of Colonoscopy for Outpatient: a RCT
Official Title  ICMJE Effecacy of Face-to-face Bowel Preparation for Afternoon Colonoscopy: a Randomised Clinical Trial
Brief Summary The study compares the efficacy of bowel preparation between the face-to-face re-education(FFRE group) and normal education (no-FFRE group) in patients.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bowel Preparation
Intervention  ICMJE
  • Behavioral: 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 one investigator at 15:00-17:00 on the day before colonoscopy.
  • Behavioral: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: telephone re-education(TRE)
  • 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.
    Intervention: Behavioral: face-to-face re-education (FFRE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2017)
658
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
600
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772250
Other Study ID Numbers  ICMJE 2016SDU-QILU-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanqing Li, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: li yanqing, PhD,MD Qilu Hospital, Shandong University
PRS Account Shandong University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP