Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy

Phase 4RecruitingNCT07696793

Fundacion Clinic per a la Recerca Biomédica818 enrolled

Overview

Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

818

Conditions

Colorectal Cancer Early Detection

Interventions

Clensia®DRUG

Participants will take the treatment in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.

Citrafleet®DRUG

Participants will take the treatment in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men and women aged 50 to 69. 2. Have participated in the early detection program for colorectal cancer. 3. Positive result in the fecal occult blood test (≥20 μg Hb/g feces). 4. Scheduled screening colonoscopy at Hospital Clínic de Barcelona. 5. Signed informed consent form. Exclusion Criteria: 1. Severe renal failure (grade IV or V) (Annex 6, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 7, NYHA Scale). 2. Colonoscopy within the last year. 3. Barthel Index of \<20 (Annex 5, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 8, Rome IV Criteria). 4. Mental disability or severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders, and bipolar disorders). 5. Do not understand spoken or written Catalan or Spanish. 6. Partial or total colon resection. 7. Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas). 8. Terminal illness or serious illness/disability that contraindicates subsequent colon study. 9. Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon). 10. Hypermagnesemia. 11. Rhabdomyolysis. 12. Phenylketonuria. 13. Glucose-6-phosphate dehydrogenase deficiency. 14. Hypersensitivity to the active ingredients of excipients. 15. Pregnancy or breastfeeding.

Locations (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Adenoma detection rate

Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)).

Time frame: week 2 (Colonoscopy visit)

Secondary Outcomes

Lesion detection rate

Lesion detection rate, defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group.

Time frame: week 2 (Colonoscopy visit)

Adenomas per colonoscopy

Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.

Time frame: week 2 (Colonoscopy visit)

Presence of foam

The presence of foam using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying \>50% of the circumference, obscuring the mucosa and require ring additional time to washing).

Time frame: week 2 (Colonoscopy visit)

Presence of bubbles

The presence of bubbles using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying \>50% of the circumference, obscuring the mucosa and require ring additional time to washing).

Time frame: week 2 (Colonoscopy visit)

Central Contacts

Maria Pellisé

CONTACT

+34 932275400 MPELLISE@clinic.cat

Judit Pich

CONTACT

+34 932275400 JPICH@recerca.clinic.cat

Data from ClinicalTrials.gov

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Quality of colon cleansing

The quality of colon cleansing using the Boston Scale, in which each colonic segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent). A total score greater than or equal to 6 and greater than or equal to 2 in each segment will be considered adequate.

Time frame: week 2 (Colonoscopy visit)

Need for washing tools during colonoscopy

Need for washing tools during colonoscopy. The amount of wash water used during the colonoscopy to complete the test satisfactorily is counted. Likewise, the volume of simethicone used will be counted if it is considered necessary.

Time frame: week 2 (Colonoscopy visit)

Cecal intubation rate

Cecal intubation rate. The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.

Time frame: week 2 (Colonoscopy visit)

Cecal intubation time

Cecal intubation time. Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.

Time frame: week 2 (Colonoscopy visit)

Endoscope removal time

Endoscope removal time. Defined as the time elapsed between reaching the cecal fundus and completion of the endoscopy, including the time spent cleaning the colon and excluding endoscopic treatment of lesions.

Time frame: week 2 (Colonoscopy visit)

Requires repeat colonoscopy due to poor preparation

Proportion of patients who, after undergoing colonoscopy, require repeat colonoscopy due to poor preparation, defined as a total score of less than 6 or less than 2 in one of the three segments according to the Boston Scale

Time frame: week 2 (Colonoscopy visit)

Adherence to the intake of the preparation

Adherence to the intake of the preparation assessed by compliance with the intake in three degrees: completely, more than 50%, less than 50% or not at all (Tolerability and satisfaction questionnaire).

Time frame: week 2 (Colonoscopy visit)

Ease of taking the preparation

Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire).

Time frame: week 2 (Colonoscopy visit)

Palatability of the preparation

Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire).

Time frame: week 2 (Colonoscopy visit)

Willingness to repeat the intake of the preparation

Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire).

Time frame: week 2 (Colonoscopy visit)

Overall satisfaction with the intake of the preparation

Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Tolerability and satisfaction questionnaire).

Time frame: week 2 (Colonoscopy visit)

Endoscopist's satisfaction with the cleaning of faecal remains and bubbles

Endoscopist's satisfaction with the cleaning of faecal remains and bubbles, assessed with a numerical assessment scale from 0 = very dissatisfied to 10 = very satisfied (Data collection form).

Time frame: week 2 (Colonoscopy visit)

Rate of adverse events

Rate of adverse events including symptoms such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness and dry mouth, which will be assessed in the Tolerability and Satisfaction Questionnaire (Tolerability and Satisfaction Questionnaire).

Time frame: week 2 (Colonoscopy visit) and week 4 (visit 2)