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

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Dietary Supplement: Clear Liquid Diet; Dietary Supplement: Low-residue Diet

• Registration Number: NCT03358537
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2016-02
• Study Completion: 2017-06
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-11-30
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-18
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clear Liquid Diet	Clear Liquid Diet	110 subjects received clear liquid diet 24 hours before colonoscopy
Low-residue Diet	Low-residue Diet	105 subjects received a prespecified low-residue diet 24 hours before colonoscopy

Primary Outcome Measures

Name	Time	Method
Quality of bowel colonoscopy preparation	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction	1 day	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.
Tolerability	1 day	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.