Clinical trial NCT02772250: Bowel Preparation by Face-to-face Re-education on the Day of Colonoscopy for Outpatient: a RCT
Official title: Effecacy of Face-to-face Bowel Preparation for Afternoon Colonoscopy: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Preparation
Keywords: bowel preparation
polyethylene glycol
face-to-face re-education
telephone re-education
Boston Bowel Preparation Scale
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Adequate bowel preparation quality at the time of colonoscopy defined by Boston Bowel Preparation Scale rating scores≥6 among 2 groups.
timeFrame: 5 months
Secondary outcomes:
measure: Rate of compliance with instructions among 2 groups
timeFrame: 5 months
Other outcomes:
measure: Willingness to repeat bowel preparation among 2 groups.
timeFrame: 5 months
measure: Polyp detection rate among 2 groups.
timeFrame: 5 months
measure: Withdrawal time among 2 groups.
timeFrame: 5 months
measure: Caecal intubation rate among 2 groups.
timeFrame: 5 months
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: li yanqing, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: