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

Colonoscopy Clinical Trial

— PEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358537
• Other study ID #: 001157
• Status: Completed
• Phase: N/A
• First received: November 25, 2017
• Last updated: March 18, 2018
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: March 2018
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: June 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Dietary Supplement:
• Clear Liquid Diet
Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group
• Low-residue Diet
Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

References & Publications (4)

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): — View 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 col — View 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 Gast — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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