Comparison of Two Methods for Bowel Preparation in Patients With Constipation

Study Overview
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Brief Summary
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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.

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

Conditions
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Health Behavior

Intervention / Treatment
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* Drug: Split dose of 4L PEG
* Drug: Three times dose of 4L PEG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Split group<br>Split-dose of 4l PEG was used before and on the day of colonoscopy | Drug: Split dose of 4L PEG<br>* 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.<br>|
| Experimental: Three times group<br>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 | Drug: Three times dose of 4L PEG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate |  | 1 year | 
| Cecal intubation rate |  | 1 year | 
| Cecal intubation time |  | 1 year | 
| Withdrawal time |  | 1 year | 
| Polyps detection rate |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG, Bowel preparation, Colonoscopy, split-does