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Completed

NCT Number: NCT03358537

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

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.

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clear Liquid Diet

Dietary Supplement

Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group

Low-residue diet

Dietary Supplement

Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Acronym: PEG

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 30, 2017
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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