Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
1 other identifier
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 29, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedNovember 29, 2017
November 1, 2017
1 month
November 20, 2017
November 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 days
Secondary Outcomes (3)
Polyp detection rate
2 days
Adenoma detection rate
2 days
The mean number of incremental adenomas
2 days
Study Arms (2)
4L Polyethylene Glycol
EXPERIMENTAL4L-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 Polyethylene Glycol
ACTIVE COMPARATOR3L-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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Outpatients aged 18-75 years
- Referred for routine diagnostic colonoscopy
- Patients who have signed inform consent form
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital, Second Military Medical University
Shanghai, 200433, China
Related Publications (1)
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.
PMID: 36105041DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peng Cheng
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastroenterology Dept and Digestive Endoscopy Center
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 29, 2017
Study Start
December 1, 2017
Primary Completion
January 1, 2018
Study Completion
February 1, 2018
Last Updated
November 29, 2017
Record last verified: 2017-11