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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Dietary supplement: Clear Liquid Diet; Dietary supplement: Low-residue Diet

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 Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

General Publications

• Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
• Park DI, Park SH, Lee SK, Baek YH, Han DS, Eun CS, Kim WH, Byeon JS, Yang SK. Efficacy of prepackaged, low residual test meals with 4L polyethylene glycol versus a clear liquid diet with 4L polyethylene glycol bowel preparation: a randomized trial. J Gastroenterol Hepatol. 2009 Jun;24(6):988-91. doi: 10.1111/j.1440-1746.2009.05860.x.
• Delegge M, Kaplan R. Efficacy of bowel preparation with the use of a prepackaged, low fibre diet with a low sodium, magnesium citrate cathartic vs. a clear liquid diet with a standard sodium phosphate cathartic. Aliment Pharmacol Ther. 2005 Jun 15;21(12):1491-5. doi: 10.1111/j.1365-2036.2005.02494.x.
• Rapier R, Houston C. A prospective study to assess the efficacy and patient tolerance of three bowel preparations for colonoscopy. Gastroenterol Nurs. 2006 Jul-Aug;29(4):305-8. doi: 10.1097/00001610-200607000-00007.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 18, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Dietary fiber
• Other Study ID Numbers: 001157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No