A Low-residue Diet vs Clear Liquid Diet as a Bowel Colonoscopy Preparation With Polyethylene Glycol (PEG)

Study Overview
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Brief Summary
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This was a randomized, endoscopists' blinded comparison of bowel colonoscopy cleansing and tolerability of a prespecified low-residue diet compared with a clear liquid diet and Polyethylene Glycol bowel preparation. Outcome measures included efficacy of bowel preparation, patient preparation tolerability and side-effects.

Detailed Description
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An adequate examination is dependent on the bowel colonoscopy cleansing of stool. There are many different colon preparations, however endoscopists traditionally recommend the patient remain on a clear liquid diet for at least 24 h prior to their colonoscopy to reduce continued residue inflow into the colon from the small bowel, in addition the large volume preparation with PEG. The most common problems leading to less than adequate colon cleansing include lack of compliance with the clear liquid diet and difficulty taking the large volume preparation.

Official Title
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A Low-residue Diet is a Good Option for Patients With PEG Based Colon Preparation: a Randomized Clinical Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Dietary Supplement: Clear Liquid Diet
* Dietary Supplement: Low-residue Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-patient scheduled for colonoscopy Exclusion Criteria: Subjects under 18 years of age Pregnancy Subjects with decompensated metabolic, renal, cardiac and psychiatric disease Allergy to PEG Refuse participation

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 215 subjects were randomly assigned for this study, 105 in the clear liquid diet and 100 in the low residue-diet, 5 subjects were excluded in each group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clear Liquid Diet<br>110 subjects received clear liquid diet 24 hours before colonoscopy | Dietary Supplement: Clear Liquid Diet<br>* Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group<br>|
| Active Comparator: Low-residue Diet<br>105 subjects received a prespecified low-residue diet 24 hours before colonoscopy | Dietary Supplement: Low-residue Diet<br>* Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel colonoscopy preparation | The quality of cleansing was recorded using the Boston Bowel Preparation Scale (BBPS), a four-point scoring system applied to each of the three broad regions of the colon (right=cecum and ascending, transverse= including the hepatic and splenic flexures and left=descending, sigmoid and rectum) during withdrawal. The point was assigned as 0= unprepared to 3=entire mucosa of colon segment seen well with no residual staining. Successful colon cleansing was considered when BBPS were >2 per segment. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Patient tolerability was assessed using Viera scale (Likert), which measures the intensity of the symptoms related to the bowel preparation including nausea, vomiting, abdominal pain, abdominal distension and anal discomfort. The six-point scale ranging from 0-1=no complaints or some; 2-3=moderate and 4-5=severe symptoms. | 1 day | 
| Satisfaction | Data on satisfaction were collected with a 1 to 10 visual analogue scale. Volume PEG consumed were evaluated as quartile (0%, 25%, 50%, 75% and 100%) prior colonoscopy. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary fiber