Comparison of Two Methods for Bowel Preparation in Patients With Constipation

Health Behavior Clinical Trial

Official title:

Comparison of Two Split-dose Regimes for Bowel Preparation in Patients With Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306030
• Other study ID #: KY20172055-2
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2017
• Last updated: November 24, 2017
• Start date: September 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2017
• Source: Fourth Military Medical University
• Contact: Hui Jia
• Phone: +862984771536
• Email: jiahuifmmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Constipation is a common high risk factor for inadequate bowel preparation. The bowel cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated patients. The investigator hypothesized that compared with the standard preparation regime, the split-dose with three times of 4L PEG may be superior in BP quality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 30, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-80 with constipation.

Exclusion Criteria:

• History of colorectal surgery BMI>30 Suspected colonic stricture or bowel obstruction Use of purgatives within 3 days Pregnancy or lactation Unable to give informed consent Haemodynamically unstable

Related Conditions & MeSH terms

• Constipation
• Health Behavior

Intervention

Drug:
• Split dose of 4L PEG
All patients were given oral instruction for bowel preparation on the day of appointment and re-instruction through phone call on two days before scheduled colonoscopy. They were instructed to have a regular lunch and take only clear liquid or low-residual food for the dinner on the day before colonoscopy. The participants began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
• Three times dose of 4L PEG
The same as mentioned above. The participants began to drink the first 1.5 L of PEG at 2:00 PM and the second 1.5L of PEG at 8:00PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients take the remaining 1.0 L 4-6 hours before colonoscopy.

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adequate bowel preparation	Adequacy of bowel preparation quality was defined as a total score =6 and each segmental score =2. The total scores included 3 scores of colonic regions: the right side, the transverse section, and the left side, which ranged from 0 to 9 (0= very poor, 9=excellent). For the unreached colon in incomplete colonoscopy, the segmental BBPS was scored as 0. The total and segmental scores were judged through videos by investigators who were familiar with the criteria and blinded to group allocation.	1 year
Secondary	Adverse event rate		1 year
Secondary	Cecal intubation rate		1 year
Secondary	Cecal intubation time		1 year
Secondary	Withdrawal time		1 year
Secondary	Polyps detection rate		1 year