NCT02415569

Brief Summary

The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

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

January 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

January 21, 2015

Last Update Submit

April 28, 2016

Conditions

Bowel Cleansing Quality

Keywords

bowel cleansingbisacodylpolyethyleneglycolcolonoscopythe bristol stool form scale

Outcome Measures

Primary Outcomes (1)

  • Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.

    This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.

    9 months

Secondary Outcomes (5)

  • Rate of non-compliance with instructions among 3 groups.

    9 months

  • Willingness to repeat bowel preparation among 3 groups.

    9 months

  • Polyp detection rate among 3 groups.

    9 months

  • Caecal intubation rate among 3 groups.

    9 months

  • Withdrawal time among 3 groups.

    9 months

Study Arms (3)

group1

EXPERIMENTAL

Subjects whose bristol stool forms are type 1 or 2, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.

Drug: Standard Bowel Prep (2L PEG-ELP)

group2

EXPERIMENTAL

Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure. ( 2L PEG-ELP and 10mg bisacodyl )

Drug: 2L PEG-ELP and 10mg bisacodyl

group3

ACTIVE COMPARATOR

Subjects whose bristol stool forms are type 3 to 7, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.

Drug: Standard Bowel Prep (2L PEG-ELP)

Interventions

Standard Bowel Prep (2L PEG-ELP)DRUG

Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure.

group1
2L PEG-ELP and 10mg bisacodylDRUG

Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure.

group2

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years of age or older,
  • scheduled to undergo elective outpatient colonoscopy,
  • and were able to provide informed consent.

You may not qualify if:

  • history of colorectal surgery
  • severe colonic stricture or obstructing tumour
  • dysphagia
  • compromised swallowing reflex or mental status
  • significant gastroparesis or gastric outlet obstruction
  • 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)
  • inflammatory bowel disease or megacolon
  • dehydration
  • disturbance of electrolytes
  • pregnancy or lactation
  • haemodynamically unstable
  • unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Bisacodyl

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • li yanqing, PhD,MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

January 21, 2015

First Posted

April 14, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

CN(1)