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Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation

Primary Purpose

Bowel Preparation Scale, Adenoma Detection Rate

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
4L Polyethylene Glycol
3L Polyethylene Glycol
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bowel Preparation Scale focused on measuring Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Outpatients aged 18-75 years
  2. Referred for routine diagnostic colonoscopy
  3. Patients who have signed inform consent form

Exclusion Criteria:

  1. pregnancy or breastfeeding
  2. allergy to purgatives
  3. suspected intestinal obstruction, stricture, or perforation
  4. hemodynamic instability
  5. impaired swallowing reflex or mental status
  6. severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
  7. history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
  8. participation declined.

Sites / Locations

  • Changhai Hospital, Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4L Polyethylene Glycol

3L Polyethylene Glycol

Arm Description

4L-group received 4 bags of PEG and were instructed to drink 2L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.

3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.

Outcomes

Primary Outcome Measures

the Boston Bowel Preparation Scale
The primary end point of the study was adequate bowel preparation quality de ned as a BBPS total score of ≥6 with all segment scores ≥2

Secondary Outcome Measures

Polyp detection rate
The secondary end point of the study included polyp detection rate
Adenoma detection rate
The secondary end point of the study included adenoma detection rate
The mean number of incremental adenomas
It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.

Full Information

First Posted
November 20, 2017
Last Updated
November 22, 2017
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03356015
Brief Title
Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
Official Title
Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
January 1, 2018 (Anticipated)
Study Completion Date
February 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

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
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Preparation Scale, Adenoma Detection Rate
Keywords
Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4L Polyethylene Glycol
Arm Type
Experimental
Arm Description
4L-group received 4 bags of PEG and were instructed to drink 2L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.
Arm Title
3L Polyethylene Glycol
Arm Type
Active Comparator
Arm Description
3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.
Intervention Type
Drug
Intervention Name(s)
4L Polyethylene Glycol
Intervention Description
4L group received double-dose PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes.
Intervention Type
Drug
Intervention Name(s)
3L Polyethylene Glycol
Intervention Description
3L group were instructed to drink 1L PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes
Primary Outcome Measure Information:
Title
the Boston Bowel Preparation Scale
Description
The primary end point of the study was adequate bowel preparation quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Polyp detection rate
Description
The secondary end point of the study included polyp detection rate
Time Frame
2 days
Title
Adenoma detection rate
Description
The secondary end point of the study included adenoma detection rate
Time Frame
2 days
Title
The mean number of incremental adenomas
Description
It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Outpatients aged 18-75 years Referred for routine diagnostic colonoscopy Patients who have signed inform consent form Exclusion Criteria: pregnancy or breastfeeding allergy to purgatives suspected intestinal obstruction, stricture, or perforation hemodynamic instability impaired swallowing reflex or mental status severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery participation declined.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaosheng Li, MD
Phone
+86-21-25070552
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Bai, MD
Phone
+86-13564665324
Email
baiyu1998@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Cheng
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36105041
Citation
Cheng P, Chen Q, Li J, Pang L, Feng C, Wang N, Bai Y, Li Z, Meng X. 3 liters of polyethylene glycol vs. standard bowel preparation have equal efficacy in a Chinese population: a randomized, controlled trial. Am J Transl Res. 2022 Aug 15;14(8):5641-5650. eCollection 2022.
Results Reference
derived

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Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation

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