Unrestricted Diet for Screening Colonoscopy

NCT05032794 | Completed

• 1 other identifier: 2021/3009
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 5

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.

Conditions

Bowel Cleansing; Colonoscopy; Bowel Cancer

Keywords

bowel cleansing; Diet; Low residue diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Diet tolerability as assessed by a likert scale

  The day of the colonoscopy just before beginning

• Preparation tolerability as assessed by a likert scale and Hatoum et al. survey

  The day of the colonoscopy just before beginning

• Rate of colonoscopies with adenoma

  With histology report, an average of 4 weeks after colonoscopy

• Rate of colonoscopies with polyps

  During colonoscopy

• Cecal intubation time

  During colonoscopy

Study Arms (2)

Unrestricted diet

EXPERIMENTAL

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; Drug: Bisacodyl 5 MG

One day low residue diet

ACTIVE COMPARATOR

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.

Other: 1-day low residue diet; Drug: Bisacodyl 5 MG

Interventions

Unrestricted diet before colonoscopy OTHER

Free diet, without restrictions

Unrestricted diet

1-day low residue diet OTHER

To follow a diet low in residues / fiber. the day before the colonoscopy.

One day low residue diet

Bisacodyl 5 MG DRUG

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.

One day low residue diet; Unrestricted diet

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc Taulí Hospital Universitari: lead

Study Sites (5)

Hospital de Mataró. Consorci Sanitari del Maresme.

Mataró, Barcelona, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Spain

Location

Hospital Universitary Mutua de Terrassa

Terrassa, Spain

Location

Related Publications (1)

• Machlab S, Martinez-Bauer E, Lopez P, Ruiz-Ramirez P, Gomez B, Gimeno-Garcia AZ, Pujals MDM, Tanco S, Sargatal L, Perez B, Justicia R, Enguita M, Pique N, Valero O, Calvet X, Campo R. Restrictive diets are unnecessary for colonoscopy: Non-inferiority randomized trial. Endosc Int Open. 2024 Mar 7;12(3):E352-E360. doi: 10.1055/a-2256-5356. eCollection 2024 Mar.

  PMID: 38464979 DERIVED

MeSH Terms

Conditions

Intestinal Neoplasms

Interventions

Bisacodyl

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Salvador Machlab

  Corporació Sanitaria Parc Taulí. Universidad Autónoma de Barcelona.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Consultant

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: September 2, 2021
• Study Start: October 13, 2021
• Primary Completion: August 19, 2022
• Study Completion: September 1, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)