Unrestricted Diet for Screening Colonoscopy (CriLiP)

Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy

Colonoscopy is the technique of choice for the evaluation of the mucosa of the colon. To be able to do the procedure in optimal conditions, it needs to be clean. Therefore, it is necessary to carry out a preparation as safe and tolerable as possible. This preparation generally consists in a low residue diet the days before the colonoscopy and in the intake of a laxative solution. In previous studies, it has been shown that the low residue diet does not play a relevant role as it was considered before. Recent studies demonstrated that reducing the days of low residue diet does not worsen the cleansing and improves the patient experience. The results of this study are required for determining the role of diet restrictive diet in colon cleansing.

Study Overview

• Status: Completed
• Conditions: Bowel Cancer; Colonoscopy; Bowel Cleansing
• Intervention / Treatment: Other: Unrestricted diet before colonoscopy; Drug: Bisacodyl 5 MG; Other: 1-day low residue diet

• Study Type: Interventional
• Enrollment (Actual): 553
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Terrassa, Spain
    • Consorci Sanitari de Terrassa
  • Terrassa, Spain
    • Hospital Universitary Mutua de Terrassa
  • Barcelona
    • Mataró, Barcelona, Spain
      • Hospital de Mataró. Consorci Sanitari del Maresme.
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Universitari Parc Tauli
  • Santa Cruz De Tenerife
    • San Cristóbal de la Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario de Canarias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals on the early colorectal cancer detection program who agreed to undergo colonoscopy after positive results on the fecal immunochemical test (FIT)

Exclusion Criteria:

• Individuals in which colonoscopy, cleansing solution or bisacodyl are contraindicated
• Subjects that are considered to have a linguistic barrier or to be unable to understand the instructions and / or give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unrestricted diet; The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation.	Other: Unrestricted diet before colonoscopy; Free diet, without restrictions; Drug: Bisacodyl 5 MG; If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.
Active Comparator: One day low residue diet; The participant is instructed to follow a low residue diet the day before the colonoscopy. It will be given a informative document and educated by a nurse.	Drug: Bisacodyl 5 MG; If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.; Other: 1-day low residue diet; To follow a diet low in residues / fiber. the day before the colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate bowel cleansing	Bowel cleansing as a rating using the Boston Bowel Preparation Scale above 1 in each segment . This score ranges fron 0 to 3 in each one of the three segments. Zero is the worst outcome and 3 is the best cleansing	During colonoscopy (At the withdrawal phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet tolerability as assessed by a likert scale	Tolerance to the diet assigned to the participant measured with a likert scale from 0 to 5, 0 the worst ad 5 the best.	The day of the colonoscopy just before beginning
Preparation tolerability as assessed by a likert scale and Hatoum et al. survey	Tolerance to the cleansing solution used for bowel cleansing measured with a likert scale from 0 to 5, 0 the worst ad 5 the best. Hatoum et al is a validated survey designed for assessing bowel preparation tolerability DOI 10.1007/s40271-015-0154-8	The day of the colonoscopy just before beginning
Rate of colonoscopies with adenoma	An adenoma was detected, resected and confirmed by the histology report in the colonoscopy.	With histology report, an average of 4 weeks after colonoscopy
Rate of colonoscopies with polyps	Polyp detection in the colonoscopy as reported by the endoscopist.	During colonoscopy
Cecal intubation time	Time expended in reaching the cecum	During colonoscopy
Withdrawal time	Time expended in the withdrawal from cecum till the anus.	During colonoscopy
Information perceived quality assessed by a likert scale	Perceived quality of the instructions and education received for the colonoscopy preparation by the participant. Assessed using a likert scale	The day of the colonoscopy just before beginning
Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale	Bowel cleansing during cecum intubation phase assessed using a modified Boston Bowel Preparation Scale which is without considering any additional cleansing during the endoscopy.	During colonoscopy (At the entry phase)
Rate of colonoscopies with flat polyps	Flat polyp detection defined by Paris criteria: no polypoid nor ulcerated (Paris 0-IIa/b/c) in the colonoscopy as reported by the endoscopist.	During colonoscopy

Collaborators and Investigators

• Sponsor: Hospital Parc Taulí, Sabadell
• Investigators: Principal Investigator: Salvador Machlab, Corporació Sanitaria Parc Taulí. Universidad Autónoma de Barcelona.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 4, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Diet; bowel cleansing; Low residue diet
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: 2021/3009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No