Clinical trial NCT05032794: Unrestricted Diet for Screening Colonoscopy
Official title: Unrestricted Diet vs 1-day Low Residue Diet for Screening Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Cleansing
Colonoscopy
Bowel Cancer
Keywords: bowel cleansing
Diet
Low residue diet
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 553
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adequate bowel cleansing
timeFrame: During colonoscopy (At the withdrawal phase)
Secondary outcomes:
measure: Diet tolerability as assessed by a likert scale
timeFrame: The day of the colonoscopy just before beginning
measure: Preparation tolerability as assessed by a likert scale and Hatoum et al. survey
timeFrame: The day of the colonoscopy just before beginning
measure: Rate of colonoscopies with adenoma
timeFrame: With histology report, an average of 4 weeks after colonoscopy
measure: Rate of colonoscopies with polyps
timeFrame: During colonoscopy
measure: Cecal intubation time
timeFrame: During colonoscopy
measure: Withdrawal time
timeFrame: During colonoscopy
measure: Information perceived quality assessed by a likert scale
timeFrame: The day of the colonoscopy just before beginning
measure: Entry bowel cleansing as assessed by the modified Boston Bowel Preparation Scale
timeFrame: During colonoscopy (At the entry phase)
measure: Rate of colonoscopies with flat polyps
timeFrame: During colonoscopy
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró. Consorci Sanitari del Maresme.
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
state: Barcelona
city: San Cristóbal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
city: Terrassa
country: Spain
facility: Hospital Universitary Mutua de Terrassa
Study officials:
affiliation: Corporació Sanitaria Parc Taulí. Universidad Autónoma de Barcelona.
name: Salvador Machlab
role: PRINCIPAL_INVESTIGATOR
References: