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Trial record 2 of 3562 for:    colon cancer AND Colonic Diseases

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

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.

Condition or disease Intervention/treatment Phase
Colonic Diseases Dietary Supplement: Low-residue diet Dietary Supplement: Usual care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cecal intubation rate [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of successful cecal intubations in each study arm

  2. Adenoma detection rate [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of polyps and adenomas detected in each study arm

  3. Polyp detection rate [ Time Frame: 1 hour after the colonoscopy ]
    Ratio of polyps and adenomas detected in each study arm

  4. Abdominal pain [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale

  5. Nausea [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale

  6. Hunger [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale

  7. Bloating [ Time Frame: 6 hours after finishing bowel preparation ]
    Each participant will rate his/her experience in an analogue visual scale

  8. Adverse events [ Time Frame: 30 days after the colonoscopy ]
    Description of all spontaneously reported adverse events.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401802


Locations
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Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Marco Antonio Alvarez González, MD, PhD Parc de Salut Mar

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marco Antonio Alvarez Gonzalez, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02401802     History of Changes
Other Study ID Numbers: DIETCOL
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Keywords provided by Marco Antonio Alvarez Gonzalez, Parc de Salut Mar:
Colonoscopy
Diet
Polyethylene glycols
Efficacy
Personal satisfaction
Colorectal cancer screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases