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Comparison of Two Methods for Bowel Preparation in Patients With Constipation

NCT ID: NCT03306030

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Health Behavior

Keywords

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PEG Bowel preparation Colonoscopy split-does

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Split group

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

Group Type ACTIVE_COMPARATOR

Split dose of 4L PEG

Intervention Type DRUG

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.

Three times group

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

Group Type EXPERIMENTAL

Three times dose of 4L PEG

Intervention Type DRUG

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.

Interventions

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Split dose of 4L PEG

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.

Intervention Type DRUG

Three times dose of 4L PEG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-80 with constipation.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hui Jia

Role: CONTACT

Phone: +862984771536

Email: [email protected]

Facility Contacts

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Hui Jia, MD

Role: primary

Other Identifiers

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KY20172055-2

Identifier Type: -

Identifier Source: org_study_id