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

Phase 4

• Conditions: Adenoma Detection Rate; Bowel Preparation Scale
• Interventions: Drug: 3L Polyethylene Glycol; Drug: 4L Polyethylene Glycol

• Registration Number: NCT03356015
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-29
• Last Update Posted: 2017-11-29
• Study Start: 2017-12-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3L 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.
4L Polyethylene Glycol	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.

Primary Outcome Measures

Name	Time	Method
the Boston Bowel Preparation Scale	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 Outcome Measures

Name	Time	Method
The mean number of incremental adenomas	2 days	It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.
Polyp detection rate	2 days	The secondary end point of the study included polyp detection rate
Adenoma detection rate	2 days	The secondary end point of the study included adenoma detection rate

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China