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

Adenoma Detection Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03356015
• Other study ID #: PEG-171116
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 20, 2017
• Last updated: November 22, 2017
• Start date: December 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: November 2017
• Source: Changhai Hospital
• Contact: Zhaosheng Li, MD
• Phone: +86-21-25070552
• Email: zhaoshenlismmu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate
• Bowel Preparation Scale

Intervention

Drug:
• 4L Polyethylene Glycol
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 Polyethylene Glycol
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

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Polyp detection rate	The secondary end point of the study included polyp detection rate	2 days
Secondary	Adenoma detection rate	The secondary end point of the study included adenoma detection rate	2 days
Secondary	The mean number of incremental adenomas	It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.	2 days