Clinical trial NCT03358537: A Low-residue Diet vs Clear Liquid Diet as a Bowel Colonoscopy Preparation With Polyethylene Glycol (PEG)
Official title: A Low-residue Diet is a Good Option for Patients With PEG Based Colon Preparation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Dietary fiber
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Quality of bowel colonoscopy preparation
timeFrame: 1 day
Secondary outcomes:
measure: Tolerability
timeFrame: 1 day
measure: Satisfaction
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.