Low-fiber Diet for Colorectal Cancer Screening Colonoscopy (DIETCOL)

Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study

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

Study Overview

• Status: Completed
• Conditions: Colonic Diseases
• Intervention / Treatment: Dietary supplement: Low-residue diet; Dietary supplement: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-residue diet; The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.	Dietary supplement: Low-residue diet; Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inadequate bowel preparation.	The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation	1 hour after the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Description of all spontaneously reported adverse events.	30 days after the colonoscopy
Adherence to the planned bowel cleansing method (questionnaire)	Each participant will rate his/her experience in a questionnaire.	6 hours after finishing bowel preparation
Acceptability of the preparation (interference with work, leisure activities or sleep	Each participant will rate his/her experience in a questionnaire.	6 hours after finishing bowel preparation
Cecal intubation rate	Ratio of successful cecal intubations in each study arm	1 hour after the colonoscopy
Adenoma detection rate	Ratio of polyps and adenomas detected in each study arm	1 hour after the colonoscopy
Polyp detection rate	Ratio of polyps and adenomas detected in each study arm	1 hour after the colonoscopy
Abdominal pain	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation
Nausea	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation
Hunger	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation
Bloating	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Marco Antonio Alvarez González, MD, PhD, Parc de Salut Mar

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Efficacy; Diet; Colonoscopy; Colorectal cancer screening; Polyethylene glycols; Personal satisfaction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Colonic Diseases
• Other Study ID Numbers: DIETCOL