Low-fiber Diet for Colorectal Cancer Screening Colonoscopy (DIETCOL)
Primary Purpose
Colonic Diseases
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Low-residue diet
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Colonic Diseases focused on measuring Colonoscopy, Diet, Polyethylene glycols, Efficacy, Personal satisfaction, Colorectal cancer screening
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
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-residue diet
Usual care
Arm Description
The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cecal intubation rate
Ratio of successful cecal intubations in each study arm
Adenoma detection rate
Ratio of polyps and adenomas detected in each study arm
Polyp detection rate
Ratio of polyps and adenomas detected in each study arm
Abdominal pain
Each participant will rate his/her experience in an analogue visual scale
Nausea
Each participant will rate his/her experience in an analogue visual scale
Hunger
Each participant will rate his/her experience in an analogue visual scale
Bloating
Each participant will rate his/her experience in an analogue visual scale
Adverse events
Description of all spontaneously reported adverse events.
Adherence to the planned bowel cleansing method (questionnaire)
Each participant will rate his/her experience in a questionnaire.
Acceptability of the preparation (interference with work, leisure activities or sleep
Each participant will rate his/her experience in a questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02401802
Brief Title
Low-fiber Diet for Colorectal Cancer Screening Colonoscopy
Acronym
DIETCOL
Official Title
Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
Keywords
Colonoscopy, Diet, Polyethylene glycols, Efficacy, Personal satisfaction, Colorectal cancer screening
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-residue diet
Arm Type
Experimental
Arm Description
The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Low-residue diet
Intervention Description
Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Usual care
Intervention Description
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 Measure Information:
Title
Inadequate bowel preparation.
Description
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
Time Frame
1 hour after the colonoscopy
Secondary Outcome Measure Information:
Title
Cecal intubation rate
Description
Ratio of successful cecal intubations in each study arm
Time Frame
1 hour after the colonoscopy
Title
Adenoma detection rate
Description
Ratio of polyps and adenomas detected in each study arm
Time Frame
1 hour after the colonoscopy
Title
Polyp detection rate
Description
Ratio of polyps and adenomas detected in each study arm
Time Frame
1 hour after the colonoscopy
Title
Abdominal pain
Description
Each participant will rate his/her experience in an analogue visual scale
Time Frame
6 hours after finishing bowel preparation
Title
Nausea
Description
Each participant will rate his/her experience in an analogue visual scale
Time Frame
6 hours after finishing bowel preparation
Title
Hunger
Description
Each participant will rate his/her experience in an analogue visual scale
Time Frame
6 hours after finishing bowel preparation
Title
Bloating
Description
Each participant will rate his/her experience in an analogue visual scale
Time Frame
6 hours after finishing bowel preparation
Title
Adverse events
Description
Description of all spontaneously reported adverse events.
Time Frame
30 days after the colonoscopy
Title
Adherence to the planned bowel cleansing method (questionnaire)
Description
Each participant will rate his/her experience in a questionnaire.
Time Frame
6 hours after finishing bowel preparation
Title
Acceptability of the preparation (interference with work, leisure activities or sleep
Description
Each participant will rate his/her experience in a questionnaire.
Time Frame
6 hours after finishing bowel preparation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Antonio Alvarez González, MD, PhD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20623443
Citation
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.
Results Reference
background
PubMed Identifier
30844973
Citation
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.
Results Reference
derived
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Low-fiber Diet for Colorectal Cancer Screening Colonoscopy
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