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

Phase 4

Completed

• Conditions: Bowel Preparation
• Interventions: Behavioral: telephone re-education(TRE); Behavioral: face-to-face re-education (FFRE)

• Registration Number: NCT02772250
• Lead Sponsor: Shandong University

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-07
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telephone re-education(TRE)	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.
face-to-face re-education (FFRE)	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.

Primary Outcome Measures

Name	Time	Method
Adequate bowel preparation quality at the time of colonoscopy defined by Boston Bowel Preparation Scale rating scores≥6 among 2 groups.	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

Name	Time	Method
Rate of compliance with instructions among 2 groups	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).

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China