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

NCT03358537 | Completed

• 1 other identifier: 001157
• Study Type: interventional
• Target: 215
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy

Keywords

Dietary fiber

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tolerability

  1 day

• Satisfaction

  1 day

Study Arms (2)

Clear Liquid Diet

ACTIVE COMPARATOR

110 subjects received clear liquid diet 24 hours before colonoscopy

Dietary Supplement: Clear Liquid Diet

Low-residue Diet

ACTIVE COMPARATOR

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

Dietary Supplement: Low-residue Diet

Interventions

Clear Liquid Diet DIETARY_SUPPLEMENT

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

Clear Liquid Diet

Low-residue Diet DIETARY_SUPPLEMENT

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

Low-residue Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-patient scheduled for colonoscopy

You may not qualify if:

• Subjects under 18 years of age
• Pregnancy
• Subjects with decompensated metabolic, renal, cardiac and psychiatric disease
• Allergy to PEG
• Refuse participation

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Related 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):1491-5. doi: 10.1111/j.1365-2036.2005.02494.x.

  PMID: 15948817 RESULT

• 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.

  PMID: 23335011 RESULT

• 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.

  PMID: 19638081 RESULT

• 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.

  PMID: 16974167 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: This was a randomized, endoscopists' blinded comparison of bowel cleanising, tolerability and quality indicators for colonoscopy
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc., Ph. D

Model Details: 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

Study Record Dates

• First Submitted: November 25, 2017
• First Posted: November 30, 2017
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share