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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bowel Preparation	Behavioral: telephone re-education(TRE); Behavioral: face-to-face re-education (FFRE)	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 658 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effecacy of Face-to-face Bowel Preparation for Afternoon Colonoscopy: a Randomised Clinical Trial
• Study Start Date: May 2016
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).

Other Outcome Measures:

1. 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
2. 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.
3. Withdrawal time among 2 groups. [ Time Frame: 5 months ]
   Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps.
4. Caecal intubation rate among 2 groups. [ Time Frame: 5 months ]
   Caecal intubation rate is defined the proportion of patients with caecal intubation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Shandong

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China, 250012

Sponsors and Collaborators

Shandong University

Investigators

• Principal Investigator: li yanqing, PhD,MD; Qilu Hospital, Shandong University

More Information

• Responsible Party: Yanqing Li, PhD,MD, Shandong University
• ClinicalTrials.gov Identifier: NCT02772250
• Other Study ID Numbers: 2016SDU-QILU-04
• First Posted: May 13, 2016
• Last Update Posted: April 10, 2017
• Last Verified: April 2017

Keywords provided by Yanqing Li, Shandong University:

bowel preparation; polyethylene glycol; face-to-face re-education; telephone re-education; Boston Bowel Preparation Scale