NCT03306030

Brief Summary

Constipation is a common high risk factor for inadequate bowel preparation. The bowel cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated patients. The investigator hypothesized that compared with the standard preparation regime, the split-dose with three times of 4L PEG may be superior in BP quality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

November 28, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

October 5, 2017

Last Update Submit

November 24, 2017

Conditions

Health Behavior

Keywords

PEGBowel preparationColonoscopysplit-does

Outcome Measures

Primary Outcomes (1)

  • Rate of adequate bowel preparation

    Adequacy of bowel preparation quality was defined as a total score ≥6 and each segmental score ≥2. The total scores included 3 scores of colonic regions: the right side, the transverse section, and the left side, which ranged from 0 to 9 (0= very poor, 9=excellent). For the unreached colon in incomplete colonoscopy, the segmental BBPS was scored as 0. The total and segmental scores were judged through videos by investigators who were familiar with the criteria and blinded to group allocation.

    1 year

Secondary Outcomes (5)

  • Adverse event rate

    1 year

  • Cecal intubation rate

    1 year

  • Cecal intubation time

    1 year

  • Withdrawal time

    1 year

  • Polyps detection rate

    1 year

Study Arms (2)

Split group

ACTIVE COMPARATOR

Split-dose of 4l PEG was used before and on the day of colonoscopy

Drug: Split dose of 4L PEG

Three times group

EXPERIMENTAL

Three times-dose of 4l PEG was used before and on the day of colonoscop of 4l PEG was used before and on the day of colonoscopy

Drug: Three times dose of 4L PEG

Interventions

Split dose of 4L PEGDRUG

All patients were given oral instruction for bowel preparation on the day of appointment and re-instruction through phone call on two days before scheduled colonoscopy. They were instructed to have a regular lunch and take only clear liquid or low-residual food for the dinner on the day before colonoscopy. The participants began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

Split group
Three times dose of 4L PEGDRUG

The same as mentioned above. The participants began to drink the first 1.5 L of PEG at 2:00 PM and the second 1.5L of PEG at 8:00PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients take the remaining 1.0 L 4-6 hours before colonoscopy.

Three times group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 with constipation.

You may not qualify if:

  • History of colorectal surgery BMI\>30 Suspected colonic stricture or bowel obstruction Use of purgatives within 3 days Pregnancy or lactation Unable to give informed consent Haemodynamically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, 710032, China

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Hui Jia

CONTACT

+862984771536jiahuifmmu@163.com

Study Design

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

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 10, 2017

Study Start

September 1, 2017

Primary Completion

August 31, 2018

Study Completion

November 30, 2018

Last Updated

November 28, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)