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

NCT ID: NCT03358537

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers
This was a randomized, endoscopists' blinded comparison of bowel cleanising, tolerability and quality indicators for colonoscopy

Study Groups

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Clear Liquid Diet

110 subjects received clear liquid diet 24 hours before colonoscopy

Group Type ACTIVE_COMPARATOR

Clear Liquid Diet

Intervention Type DIETARY_SUPPLEMENT

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

Low-residue Diet

105 subjects received a prespecified low-residue diet 24 hours before colonoscopy

Group Type ACTIVE_COMPARATOR

Low-residue Diet

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Clear Liquid Diet

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

Intervention Type DIETARY_SUPPLEMENT

Low-residue Diet

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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FELIX IGNACIO TELLEZ AVILA

M.D., M.Sc., Ph. D

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 15948817 (View on PubMed)

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.

Reference Type RESULT
PMID: 23335011 (View on PubMed)

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.

Reference Type RESULT
PMID: 19638081 (View on PubMed)

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.

Reference Type RESULT
PMID: 16974167 (View on PubMed)

Other Identifiers

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001157

Identifier Type: -

Identifier Source: org_study_id

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