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

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ClinicalTrials.gov Identifier: NCT03358537
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
FELIX IGNACIO TELLEZ AVILA, 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Dietary Supplement: Clear Liquid Diet Dietary Supplement: Low-residue Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Care Provider)
Masking Description: This was a randomized, endoscopists' blinded comparison of bowel cleanising, tolerability and quality indicators for colonoscopy
Primary Purpose: Other
Official Title: A Low-residue Diet is a Good Option for Patients With PEG Based Colon Preparation: a Randomized Clinical Trial
Actual Study Start Date : June 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. Quality of bowel colonoscopy preparation [ Time Frame: 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 :
  1. Tolerability [ Time Frame: 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.

  2. Satisfaction [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Publications of Results:
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Responsible Party: FELIX IGNACIO TELLEZ AVILA, M.D., M.Sc., Ph. D, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03358537    
Other Study ID Numbers: 001157
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FELIX IGNACIO TELLEZ AVILA, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Dietary fiber