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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401802
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Marco Antonio Alvarez Gonzalez, Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE March 17, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
Inadequate bowel preparation. [ Time Frame: 1 hour after the colonoscopy ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02401802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
  • Cecal intubation rate [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of successful cecal intubations in each study arm
  • Adenoma detection rate [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of polyps and adenomas detected in each study arm
  • Polyp detection rate [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of polyps and adenomas detected in each study arm
  • Abdominal pain [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale
  • Nausea [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale
  • Hunger [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale
  • Bloating [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale
  • Adverse events [ Time Frame: 30 days after the colonoscopy ]
    Description of all spontaneously reported adverse events.
  • Adherence to the planned bowel cleansing method (questionnaire) [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in a questionnaire.
  • Acceptability of the preparation (interference with work, leisure activities or sleep [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in a questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-fiber Diet for Colorectal Cancer Screening Colonoscopy
Official Title  ICMJE Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Colonic Diseases
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Low-residue diet
    The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.
    Intervention: Dietary Supplement: Low-residue diet
  • 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.

    Intervention: Dietary Supplement: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2015)
276
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02401802
Other Study ID Numbers  ICMJE DIETCOL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Antonio Alvarez Gonzalez, Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marco Antonio Alvarez González, MD, PhD Parc de Salut Mar
PRS Account Parc de Salut Mar
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP