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Completed

NCT Number: NCT02772250

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

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.

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Key information

Conditions

Bowel Preparation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telephone re-education(TRE)

Behavioral

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.

face-to-face re-education (FFRE)

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Effecacy of Face-to-face Bowel Preparation for Afternoon Colonoscopy: a Randomised Clinical Trial

Acronym: FFRE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 13, 2016
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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