Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

Colonic Diseases Clinical Trial

— DIETCOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401802
• Other study ID #: DIETCOL
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: February 14, 2017
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Diseases
• Colorectal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cecal intubation rate	Ratio of successful cecal intubations in each study arm	1 hour after the colonoscopy
Secondary	Adenoma detection rate	Ratio of polyps and adenomas detected in each study arm	1 hour after the colonoscopy
Secondary	Polyp detection rate	Ratio of polyps and adenomas detected in each study arm	1 hour after the colonoscopy
Secondary	Abdominal pain	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation
Secondary	Nausea	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation
Secondary	Hunger	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation
Secondary	Bloating	Each participant will rate his/her experience in an analogue visual scale	6 hours after finishing bowel preparation
Secondary	Adverse events	Description of all spontaneously reported adverse events.	30 days after the colonoscopy
Secondary	Adherence to the planned bowel cleansing method (questionnaire)	Each participant will rate his/her experience in a questionnaire.	6 hours after finishing bowel preparation
Secondary	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