Skip to main content
Clinical Trials/NCT03356015
NCT03356015
Unknown
Phase 4

Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation

Changhai Hospital1 site in 1 country260 target enrollmentDecember 1, 2017

Overview

Phase
Phase 4
Intervention
4L Polyethylene Glycol
Conditions
Bowel Preparation Scale
Sponsor
Changhai Hospital
Enrollment
260
Locations
1
Primary Endpoint
the Boston Bowel Preparation Scale
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
February 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhaoshen Li

Director of Gastroenterology Dept and Digestive Endoscopy Center

Changhai Hospital

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.

Arms & Interventions

4L Polyethylene Glycol

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.

Intervention: 4L Polyethylene Glycol

3L Polyethylene Glycol

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: 3L Polyethylene Glycol

Outcomes

Primary Outcomes

the Boston Bowel Preparation Scale

Time Frame: 2 days

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 Outcomes

  • The mean number of incremental adenomas(2 days)
  • Polyp detection rate(2 days)
  • Adenoma detection rate(2 days)

Study Sites (1)

Loading locations...

Similar Trials