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Comparison of Two Methods for Bowel Preparation in Patients With Constipation

Primary Purpose

Health Behavior

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Split dose of 4L PEG
Three times dose of 4L PEG
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Health Behavior focused on measuring PEG, Bowel preparation, Colonoscopy, split-does

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endoscopic center, Xijing Hospital of Digestive DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Split group

Three times group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse event rate
Cecal intubation rate
Cecal intubation time
Withdrawal time
Polyps detection rate

Full Information

First Posted
October 5, 2017
Last Updated
November 24, 2017
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03306030
Brief Title
Comparison of Two Methods for Bowel Preparation in Patients With Constipation
Official Title
Comparison of Two Split-dose Regimes for Bowel Preparation in Patients With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior
Keywords
PEG, Bowel preparation, Colonoscopy, split-does

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Split group
Arm Type
Active Comparator
Arm Description
Split-dose of 4l PEG was used before and on the day of colonoscopy
Arm Title
Three times group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Split dose of 4L PEG
Intervention Description
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
Intervention Name(s)
Three times dose of 4L PEG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of adequate bowel preparation
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse event rate
Time Frame
1 year
Title
Cecal intubation rate
Time Frame
1 year
Title
Cecal intubation time
Time Frame
1 year
Title
Withdrawal time
Time Frame
1 year
Title
Polyps detection rate
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Jia
Phone
+862984771536
Email
jiahuifmmu@163.com
Facility Information:
Facility Name
Endoscopic center, Xijing Hospital of Digestive Diseases
City
Xi'an
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Jia, MD
Phone
+862984771536
Email
jiahuifmmu@163.com
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Two Methods for Bowel Preparation in Patients With Constipation

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