NCT03704571

Brief Summary

We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
429

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

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

First Submitted

Initial submission to the registry

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

October 10, 2018

Last Update Submit

October 30, 2019

Conditions

Bowel Preparation

Keywords

adenomabowel preparationcolonoscopypredictive modelrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Quality of Bowel Preparation

    The quality of bowel preparation is evaluated using BBPS.

    10 months

Secondary Outcomes (3)

  • Adenoma Detection Rate

    10 months

  • Polyp Detection Rate

    10 months

  • Adverse Events

    10 months

Study Arms (2)

Tailored Group

EXPERIMENTAL

In the tailored group, high-risk patients are instructed to drink the first 2 L of Polyethylene Glycol (PEG) at 19:00-21:00 hours on the day before colonoscopy at a rate of 250 ml every 15 min. On the day of the procedure, they take another 2 L PEG 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy.

Drug: Polyethylene Glycol

Control Group

ACTIVE COMPARATOR

In the control group, all the patients drink single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min.

Drug: Polyethylene Glycol

Interventions

Polyethylene GlycolDRUG

In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens. In the control group, all the patients are given routine regimens.

Control GroupTailored Group

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-75 years undergoing colonoscopy

You may not qualify if:

  • known or suspected bowel obstruction, stricture or perforation
  • compromised swallowing reflex or mental status
  • 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)
  • dehydration
  • disturbance of electrolytes
  • pregnancy or lactation
  • hemodynamically unstable
  • unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Adenoma

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Xiuli Zuo, MD, PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

November 1, 2018

Primary Completion

July 31, 2019

Study Completion

August 30, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

CN(1)