Comparison of Two Methods for Bowel Preparation in Patients With Constipation

Not Applicable

• Conditions: Health Behavior
• Interventions: Drug: Split dose of 4L PEG; Drug: Three times dose of 4L PEG

• Registration Number: NCT03306030
• Lead Sponsor: Air Force Military Medical University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-10
• Last Update Submitted: 2017-11-24
• Last Update Posted: 2017-11-28
• Primary Completion: 2018-08-31
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Split group	Split dose of 4L PEG	Split-dose of 4l PEG was used before and on the day of colonoscopy
Three times group	Three times dose of 4L PEG	Three times-dose of 4l PEG was used before and on the day of colonoscop of 4l PEG was used before and on the day of colonoscopy

Primary Outcome Measures

Name	Time	Method
Rate of adequate bowel preparation	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Polyps detection rate	1 year
Withdrawal time	1 year
Adverse event rate	1 year
Cecal intubation rate	1 year
Cecal intubation time	1 year

Trial Locations

Locations (1)

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, China