Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

Study Overview
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Brief Summary
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the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different.

Detailed Description
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In-hospital patients were randomly assigned to one of three groups: group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h); group 2: split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am); group 3: low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am). The quality of colonic preparation was assessed by the Boston bowel preparation scale (13); tolerability (nausea, vomiting, and abdominal pain), compliance, sleep disturbance and adverse effects in group 3 were compared with those in groups 1 and 2. The time since the last dose of bowel-preparation agent, the time since the last solid food was consumed, the approximate amount of bowel preparation taken (0%, 25%, 75%, or 100%), and the start time of the colonoscopy were recorded. Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

Official Title
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Efficacy and Tolerability of Low-volume Polyethylene Glycol (2 L) vs. Single- (4 L) vs. Split-dose (2L + 2L) of Polyethylene Glycol Bowel Preparation for Colonoscopy: a Randomized Clinical Trial.

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Drug: PEG-3350 group 2
* Drug: PEG-3350 group 1
* Drug: PEG-3350 group 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In-hospital patients with an indication for colonoscopy Exclusion Criteria: patients under 18 years of age the presence of a severe illness (cardiac, renal, or metabolic) major psychiatric illness known allergies to PEG-3350 refusal to consent to the study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEG-3350 group 3<br>group 3: low-volume 2 L PEG-3350 solution (same day of the procedure 06:00-08:00 am). | Drug: PEG-3350 group 3<br>* low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)<br>* Other names: Nulytely;|
| Active Comparator: PEG-3350 group 1<br>group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h) | Drug: PEG-3350 group 1<br>* PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h<br>* Other names: Nulytely;|
| Experimental: PEG-3350 group 2<br>group 2: split-dose (PEG-3350 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am) | Drug: PEG-3350 group 2<br>* split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)<br>* Other names: Nulytely;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfactory bowel preparation | The aim of this study was to test the quality of bowel preparation and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments. The quality of colonic preparation was assessed by the Boston bowel preparation scale.Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation. | at the moment of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability with bowel preparation | tolerability of bowel preparation was measured, considering: nausea, vomiting, and abdominal pain, compliance, sleep disturbance and adverse effects. | just before to start the colonoscopy and before any sedative be administered | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Preparation, Polyp, Polyethylene glycol