NCT01911052

Brief Summary

Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates of missing important lesions, increased patient discomfort, higher risk of complications, prolonged procedure time and increased health-care cost. Recent study reported that Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the quality of bowel preparation and polyp detection rate. However, there is no study to compare the effect of telephone with short message system (SMS) based re-education on the quality of bowel preparation in health screened population. Our goal is to improve the quality of bowel preparation with telephone or SMS based re-education for outpatients undergoing screening colonoscopies. The investigators hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

July 22, 2013

Last Update Submit

July 16, 2014

Conditions

Bowel Preparation

Keywords

Bowel preparation

Outcome Measures

Primary Outcomes (1)

  • Quality of bowel preparation

    The primary outcomes will be the endoscopist's assessment of the quality of preparation using Boston and Ottawa bowel preparation scare

    day 1

Secondary Outcomes (1)

  • polyp detection rate

    day 1

Other Outcomes (1)

  • Patient compliance

    baseline

Study Arms (3)

Intervention

EXPERIMENTAL

The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy.

Other: Telephone based re-education

Standard preparation instructions

NO INTERVENTION

The control arm will receive written instruction on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center

Interventional

EXPERIMENTAL

The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy.

Other: Short message system based re-education

Interventions

Telephone based re-educationOTHER

The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy.

Intervention
Short message system based re-educationOTHER

The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy.

Interventional

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All health screened populations
  • age \>18
  • scheduled for an elective screening colonoscopy

You may not qualify if:

  • inpatients
  • pregnancy
  • breast feeding
  • prior history of surgical large bowel resection
  • patients allergic to PEG-ELS based laxatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eun Soo Kim

Daegu, 700-712, South Korea

Location

Related Publications (2)

  • Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.

    PMID: 23503044BACKGROUND

  • Lee YJ, Kim ES, Choi JH, Lee KI, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy. 2015 Nov;47(11):1018-27. doi: 10.1055/s-0034-1392406. Epub 2015 Jul 16.

    PMID: 26182387DERIVED

Study Officials

  • Eun Soo Kim, Professor

    Keimyung University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 30, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

KR(1)