Clinical trial NCT02401802: Low-fiber Diet for Colorectal Cancer Screening Colonoscopy
Official title: Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diseases
Keywords: Colonoscopy
Diet
Polyethylene glycols
Efficacy
Personal satisfaction
Colorectal cancer screening
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Inadequate bowel preparation.
timeFrame: 1 hour after the colonoscopy
Secondary outcomes:
measure: Cecal intubation rate
timeFrame: 1 hour after the colonoscopy
measure: Adenoma detection rate
timeFrame: 1 hour after the colonoscopy
measure: Polyp detection rate
timeFrame: 1 hour after the colonoscopy
measure: Abdominal pain
timeFrame: 6 hours after finishing bowel preparation
measure: Nausea
timeFrame: 6 hours after finishing bowel preparation
measure: Hunger
timeFrame: 6 hours after finishing bowel preparation
measure: Bloating
timeFrame: 6 hours after finishing bowel preparation
measure: Adverse events
timeFrame: 30 days after the colonoscopy
measure: Adherence to the planned bowel cleansing method (questionnaire)
timeFrame: 6 hours after finishing bowel preparation
measure: Acceptability of the preparation (interference with work, leisure activities or sleep
timeFrame: 6 hours after finishing bowel preparation
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Parc de Salut Mar
name: Marco Antonio Alvarez González, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.