NCT04664543: CriLi

Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy

Terminated NA Last updated 26 January 2021

What this trial tests

NA trial testing Free diet in Colorectal Cancer in 100 participants. Terminated before completion.

Timeline

1 December 2019

Primary endpoint
30 December 2020

30 December 2020

Quick facts

Lead sponsor	Parc Taulí Hospital Universitari
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	diagnostic
Enrollment	100
Start date	1 December 2019
Primary completion	30 December 2020
Estimated completion	30 December 2020
Sites	1 location across Spain

Drugs / interventions tested

• Free diet
• Three days low residue diet

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Colon Polyp — all drugs for Colon Polyp →
• Colon Adenoma — all drugs for Colon Adenoma →

Sponsor

Parc Taulí Hospital Universitari

Who can join

Adults 50 to 69, any sex, with Colorectal Cancer or Colon Polyp. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One tricky aspect of the recommendations for colonoscopy prep is diet. This has a significant impact on the experience of the patient or participant in the screening program and, on the other hand, low adherence has been found in some studies despite a potential Hawthorne effect . It is noteworthy that despite its impact on patient experience, it is an area for which little evidence is available, which is why the guidelines give low-quality recommendations and there is probably considerable variability in clinical practice .

In the early days of colonoscopy, a liquid diet for 48 hours was mainly recommended, although some centers indicated a low-residue diet or even the commercially available NASA astronaut diet. Later, the indication for a liquid diet was consolidated until finally numerous studies were published in favor of a low-residue diet, managing to increase tolerance and the quality of the preparation . A limitation of the preparation studies must be borne in mind that the colon cleansing rating scales were not introduced until 1999 when the Aronchick scale was published.

Although there is solid evidence in favor of a low-residue diet versus a liquid diet, the investigators do not have evidence on how many days of a low-residue diet should be recommended, and this is reflected in the ESGE (European Society of Gastrointestinal Endoscopy) and ASGE (American Society of Gastrointestinal Endoscopy) guidelines . A randomized clinical trial comparing 3 days versus 1 day of a low residue diet has recently been published . There were no statistically significant differences in the rate of adequate preparations (82.7% vs. 85.6% OR 1.2 95% IC 0.72 to 2.15). However, this study has limited statistical power and a design that allows a non-inferiority analysis has not been followed. In relation to this, our research group is finalizing a non-inferiority clinical trial in whose intermediate analysis, with 421 participants, the non-inferiority of 1 day of diet is fulfilled (rate of poor preparation in 1 day 0.95% vs. 4.74% in 3 days; d + 5%, difference -3.78% IC -6.88% to -1.12%) (38).

It is likely, taking into account the available evidence and its evolution, that diet plays a secondary role in preparation. Although no studies designed to directly assess this have been conducted, the research group has indirect data.

Walter et al, under the hypothesis that the impact of the fractional preparation and the new preparations on the preparation diminished the importance of the diet, conducted a non-inferiority clinical trial between 2012 and 2013 in which they randomized the patients to follow a diet liquid versus low residue for one day and fractional preparation with Moviprep (39). They established a non-inferiority margin of -13.5%. Their results show a rate of good preparation (Boston\> 5) in 68/72 (94.4%) in a liquid diet compared to 60/68 (88.2%) in a low-residue diet (p = 0.04) with a difference of -5.08% demonstrating non-inferiority of the low residue diet.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Unrestricted vs three-day low-residue diet for colonoscopy preparation. Results of a feasibility randomized trial.
   Machlab Mashlab S, Martínez-Bauer E, López P, Pujals MDM, et al · · 2025 · PMID 38591600 · DOI 10.17235/reed.2024.10417/2024