Gastrointestinal Agents

All Drugs and Chemicals

Bisacodyl

Laxatives

Cathartics

The participant is not instructed to follow any dietary recommendation before colonoscopy. But only the restriction and fasting required for sedation.

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.

Unrestricted diet before colonoscopy

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

1-day low residue diet

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.

Bisacodyl 5 MG

Salvador Machlab

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.

Unrestricted Diet for Screening Colonoscopy

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

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

Tolerance to the diet assigned to the participant measured with a likert scale from 0 to 5, 0 the worst ad 5 the best.

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

An adenoma was detected, resected and confirmed by the histology report in the colonoscopy.

Polyp detection in the colonoscopy as reported by the endoscopist.

Time expended in the withdrawal from cecum till the anus.

Perceived quality of the instructions and education received for the colonoscopy preparation by the participant. Assessed using a likert 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.

Flat polyp detection defined by Paris criteria: no polypoid nor ulcerated (Paris 0-IIa/b/c) in the colonoscopy as reported by the endoscopist.

Parc Taulí Hospital Universitari

Gastroenterology Consultant

Digestive System Diseases

All Conditions

Neoplasms

Colonic Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Group A - 3 day low residue diet prior to the colonoscopy

Group B - 1 day low residue diet prior to the colonoscopy

3 day low residue diet prior to the colonoscopy

1 day low residue diet prior to the colonoscopy

Filipe Taveira, MD

Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases and provides a unique opportunity to identify early neoplastic lesions.

Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing regimens, study of patient-related risk factors to fail a proper preparation and diet adaptations have been studied recently.

A low residue diet is the standard in the day before the colonoscopy. Some endoscopists prescribe this dietary plan for a 3-day period prior to the exam, although no study compared the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation results.

The aim of this project is to determine if the use of a 3-day low residue diet improves bowel preparations results and the influence in patient tolerability and adherence.

a. Study type: prospective, randomized, single-blinded trial:

i. Prospective inclusion of ambulatory patients;

ii. Randomization by computer generated tables;

iii. Allocation concealment by sealed, opaque envelopes;

iv. Patient not blinded to diet;

v. Endoscopist blinded to the diet followed by each patient.

b. Patient selection: Consecutive series of patients scheduled for total colonoscopy; Exclusion criteria: inpatients, sedation, urgent procedures, colonoscopies not intended to reach the caecum, patient with previous partial colectomy.

c. Sample Size:

i. 412 individuals; 2 groups of 206 patients

ii. Primary goal: to achieve a reduction from 15 to 5% of inappropriate preparation result; The Boston Bowel Preparation Scale (BBPS) will be used as grading system. Inappropriate is defined as total BBPS \< 6 or \< 2 in any segment. The chosen scale is the most systematically validated and appropriate for the clinical setting. iii.Both groups, from a community-based outpatient ambulatory center, used the same split dose regimen with Polyethylene glycol (PEG).Patients were instructed to drink 3 L of PEG preparation on the afternoon of the day prior to the exam and 1 L four hours before the scheduled exam time. All the exams scheduled for morning period. Assuming a normal distribution, a power of 90% and a type I error of 0.05, the calculated sample size for each group was 188; allowing a 10% dropout rate, the sample size is 206 per group (412 patients overall); Groups: Group A: 3-day low residue diet + split dose preparation; Group B: 1-day low residue diet + split dose preparation

d. Endoscopist:

Exams to be conduct by 5 board-certified gastroenterologists and 2 supervised fellows in training; All physicians were trained in the use of BBPS by online training available at http://cori.org/bbps/, and have been using the BBPS for at least 3 months.

e. Data collection methods: form sheet filled by the endoscopist and patient opinion regarding the assigned bowel preparation protocol.

f. Analyzed variables:

i. Primary outcome: BBPS score

ii. Secondary outcome: Patient assessment of tolerance and acceptance of the preparation and diet

iii. Tertiary outcome: polyp detection rate (PDR), polyp location, size and configuration; adenoma detection rate (ADR), cecum intubation rate

iv. Other variables and patients characteristics (age, gender, chronic medication, risk factors for inappropriate preparation), withdrawal time.

g. Statistical analysis: T-test for groups comparing quantitative variables with normal distribution (primary outcome); Qui square test for groups comparing proportions (secondary and tertiary outcomes)

3-day vs. 1-day Low Residue Diet Influence in Colonoscopy Preparation and Patient Tolerability

A 3-day Versus 1-day Low Residue Diet to Improve Colonoscopy Preparation Result and Patient Tolerability: A Prospective, Randomized, Single-blinded, Controlled Trial

Evaluate, using proper data collecting sheet, patient relevant data (age, gender, chronic medication, risk factors for inappropriate preparation)

Using Boston Bowel Preparation Scale during the exam

Patient assessment, by written questionnaire, of tolerance and acceptance of diet protocol.

One of the quality indicators for colonoscopy is polyp detection rate, which is defined as the percentage of colonoscopies with a detection of at least one polyp. At the same time the endoscopist will assign the colonic location of the polyp (ascendent, transverse, descendent).

(PDR to be presented as %; Location to be discriminated in the endoscopist report).

Adenoma detection rate (ADR) is the one of the strongest quality indicators for colonoscopy. This rate represents the percentage of colonoscopies with at least one adenoma identified. (to be presented as %)

Defined as colonoscopy quality indicator the photo documentation of cecum, in at least 95% of the colonoscopies. Photo documentation of the cecum is a mark for effective total colonoscopy. (to presented as %)

In a negative colonoscopy (no polyp identification) is defined that the withdrawal time should be at least 6 minutes for proper and safe colonic mucosa evaluation. (to be presented in minutes)

Portuguese Oncology Institute, Coimbra

Principal Investigator

Adenoma

Inflammatory Bowel Diseases

Gastroenteritis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Rectal Diseases

Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.

Patients are instructed to complete a low residue diet three days prior the colonoscopy.

Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.

1 day low residue diet

3 day low residue diet

Eva Martínez, PhD

Salvador Machlab, MD

Rafel Campo, PhD

Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.

The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.

The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.

Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy

Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial

Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.

Using Likert scale. From 1 to 5, lower is better tolerance.

Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic

Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.

Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.

time lapse from the start of the exploration until cecum is reached.

Time lapse between cecum withdrawal the end of the exploration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Unrestricted Diet for Screening Colonoscopy	NCT05032794	Bowel Cleansing Colonoscopy Bowel Cancer	Unrestricted di... 1-day low resid... Bisacodyl 5 MG	50 Years - 70 Years	Parc Taulí Hospital Universitari
3-day vs. 1-day Low Residue Diet Influence in Colonoscopy Preparation and Patient Tolerability	NCT02955901	Colon Disease Colonic Neoplas...	3 day low resid... 1 day low resid...	18 Years -	Portuguese Oncology Institute, Coimbra
Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy	NCT03763266	Colonoscopy Colon Adenoma Colorectal Neop... Inflammatory Bo... Colon Disease	1 day low resid... 3 day low resid...	50 Years - 69 Years	Parc Taulí Hospital Universitari
3-day vs. 1-day Low Residue Diet Influence in Colonoscopy Preparation and Patient Tolerability	NCT02955901	Colon Disease Colonic Neoplas...	3 day low resid... 1 day low resid...	18 Years -	Portuguese Oncology Institute, Coimbra
3-day vs. 1-day Low Residue Diet Influence in Colonoscopy Preparation and Patient Tolerability	NCT02955901	Colon Disease Colonic Neoplas...	3 day low resid... 1 day low resid...	18 Years -	Portuguese Oncology Institute, Coimbra
3-day vs. 1-day Low Residue Diet Influence in Colonoscopy Preparation and Patient Tolerability	NCT02955901	Colon Disease Colonic Neoplas...	3 day low resid... 1 day low resid...	18 Years -	Portuguese Oncology Institute, Coimbra

Spots Global Cancer Trial Database for low residue diet