Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

NCT ID: NCT02401802

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

Brief Summary

This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.

Detailed Description

There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability.

All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.

Conditions

Colonic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Low-residue diet

The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.

Group Type: EXPERIMENTAL

Low-residue diet

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days

Usual care

The control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet.

Laxative 4 liters polyethylene glycol 4000 in split fashion.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet

Interventions

Low-residue diet

Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days

Intervention Type: DIETARY_SUPPLEMENT

Usual care

Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.

Exclusion Criteria

• Unwillingness to participate.
• Inability to follow instructions
• Active inflammatory bowel disease
• Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Marco Antonio Alvarez Gonzalez

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Antonio Alvarez González, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar

Locations

Hospital del Mar

Barcelona, Barcelona, Spain

Countries

Spain

References

Soweid AM, Kobeissy AA, Jamali FR, El-Tarchichi M, Skoury A, Abdul-Baki H, El-Zahabi L, El-Sayyed A, Barada KA, Sharara AI, Mourad F, Arabi A. A randomized single-blind trial of standard diet versus fiber-free diet with polyethylene glycol electrolyte solution for colonoscopy preparation. Endoscopy. 2010 Aug;42(8):633-8. doi: 10.1055/s-0029-1244236. Epub 2010 Jul 9.

Reference Type: BACKGROUND

PMID: 20623443 (View on PubMed)

Alvarez-Gonzalez MA, Pantaleon MA, Flores-Le Roux JA, Zaffalon D, Amoros J, Bessa X, Seoane A, Pedro-Botet J; PROCOLON group. Randomized Clinical Trial: A Normocaloric Low-Fiber Diet the Day Before Colonoscopy Is the Most Effective Approach to Bowel Preparation in Colorectal Cancer Screening Colonoscopy. Dis Colon Rectum. 2019 Apr;62(4):491-497. doi: 10.1097/DCR.0000000000001305.

Reference Type: DERIVED

PMID: 30844973 (View on PubMed)

Other Identifiers

DIETCOL

Identifier Type: -

Identifier Source: org_study_id