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

Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy: CriLi Study, a Pilot Trial

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Colon Adenoma; Colon Polyp
• Intervention / Treatment: Other: Three days low residue diet; Other: Free diet

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Universitari Parc Taulí

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women between 50 and 69 years old.
• Participants in the Program for the Early Detection of Colorectal Cancer with a positive result in the test for detecting occult blood in feces
• That they accept a colonoscopy and that they agree to participate in the study.

Exclusion Criteria:

• Contraindication to performing a colonoscopy.
• Severe renal insufficiency (<30 ml / min).
• Known hypersensitivity or allergy to polyethylene glycol, ascorbic acid or sulfate.
• Known glucose-6-phosphate dehydrogenase deficiency.
• Known phenylketonuria.
• Known dyselectrolytemia: hyper / hyponatremia, hyperphosphatemia, hypermagnesemia, hyper / hypokalemia, hypocalcemia.
• Gastric emptying disorders: Known gastroparesis.
• Known hypoalbuminemia less than 3.4 g / dl.
• Crohn's disease or known ulcerative colitis.
• Participants with difficult-to-control hypertension (SBP> 170mmHg or TAD> 100mmHg) or NYHA grade III or IV heart failure.
• Ascites of any etiology
• People with cognitive impairment or mental illness that makes it difficult to adhere to instructions.
• People who do not understand Catalan or Spanish.
• Factors of poor preparation: liver cirrhosis, diabetes mellitus, treatment with tricyclic antidepressants, opioids or neuroleptics, limited mobility, chronic constipation, history of colon or intestinal resection (appendectomy is not an exclusion criterion), poor preparation in previous colonoscopy Parkinson's disease, multiple sclerosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 3 days of low residue diet; Currently participants in the colorectal cancer screening program follow a 3 days low residue diet before colonoscopy. This is the active comparator arm of this study.	Other: Three days low residue diet; To follow the three days before colonoscopy a diet with low content in fiber or residues.; Other Names: low fiber diet
EXPERIMENTAL: Free diet; Participants assigned to this arm are NOT instructed to follow any kind of restriction in the diet before colonoscopy.	Other: Free diet; To follow the regular dietary habits with no restriction nor modification.; Other Names: Liberal diet, habitual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate bowel cleansing	Bowel cleansing has 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
Withdrawal time	Time expended in the withdrawal from cecum till the anus.	During colonoscopy
Diet tolerability	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	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.	The day of the colonoscopy just before beginning
Adenoma detection	An adenoma was detected, resected and confirmed by the histology report in the colonoscopy.	adenoma detection is done during the colonoscopy but assesment will be done at the end of the study with the histology reports
Polyp detection	Polyp detection in the colonoscopy as reported by the endoscopist.	During colonoscopy
Ceacal intubation time	Time expended in reaching the cecum	During colonoscopy
Excellent cleansing	Colonoscopy achieving a Boston Bowel Preparation Scale (BBPS) of at least 8 points or above. BBPS global score ranges from 0 to 9, being 9 the best cleansing outcome.	During colonoscopy
Information perceived quality	Perceived quality of the instructions and education received for the colonoscopy. preparation by the participant. Assessed using a likert scale from 0 to 5. Five is the best outcome and 0 the worst.	The day of the colonoscopy just before beginning
Preparation quality in each segment	Boston Bowel Preparation Score in each segment, it ranges from 0 to 3 being 3 the best cleansing outcome and 0 the worst.	During colonoopy

Collaborators and Investigators

• Sponsor: Hospital Parc Taulí, Sabadell
• Collaborators: Hospital Mutua de Terrassa; Consorci Sanitari de Terrassa
• Investigators: Study Director: Eva Martínez, PhD, Hospital Universitari Parc Taulí

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): December 30, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: colonoscopy; bowel cleansing; colonoscopy preparation; low fiber diet
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2019307

Drug and device information, study documents

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