NCT01584817

Brief Summary

Cell phone retell the instruction of bowel preparation on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
605

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

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

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

April 24, 2012

Last Update Submit

December 1, 2013

Conditions

Ottawa ScoreAdenoma

Keywords

colonoscopybowel preparationeducation

Outcome Measures

Primary Outcomes (1)

  • Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6

    Ottawa score：A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2 The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons; (3) incomplete colonoscopy.

    up to 3 months

Secondary Outcomes (5)

  • Cecum intubation time

    up to 3 months

  • Withdrawal time

    up to 3 months

  • Polyp detection rate

    up to 3 months

  • Compliance rate to instruction

    up to 3 months

  • Willingness undergo a repeated bowel preparation

    up to 3 months

Study Arms (2)

normal education

NO INTERVENTION

patients in this arm was educated about bowel preparation on the day of reservation by nurse for 15 minutes and meanwhile a booklet was also sent to them.

telephone education

OTHER

A repeated instruction by telephone on the day before colonoscopy was conducted

Other: telephone education

Interventions

telephone educationOTHER

A repeated instruction by telephone on the day before colonoscopy was conducted

telephone education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing colonoscopy

You may not qualify if:

  • disturbance of water and electrolyte
  • history of colorectal surgery
  • severe colonic stricture or obstructing tumor
  • known or suspected bowel obstruction or perforation
  • toxic colitis or megacolon
  • dysphagia
  • compromised swallowing reflex or mental status
  • significant gastroparesis or gastric outlet obstruction or ileus
  • severe chronic renal failure (creatinine clearance \<30 mL/minute)
  • severe congestive heart failure (New York Heart Association class III or IV)
  • uncontrolled hypertension (average systolic blood pressure \>170 mm Hg, average diastolic blood pressure \>100 mm Hg)
  • pregnant or lactating women
  • patients who cannot give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • 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: 23503044DERIVED

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • pan yanglin, MD.

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 25, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

CN(1)