Colorectal Cancer Early Detection
Conditions
Brief summary
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
Interventions
DRUGClensia®
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.
DRUGCitrafleet®
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.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
blind endoscopist, unblinded nurse and patient
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | week 2 (Colonoscopy visit) | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion detection rate | week 2 (Colonoscopy visit) | 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. |
| Adenomas per colonoscopy | week 2 (Colonoscopy visit) | Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group. |
| Presence of foam | week 2 (Colonoscopy visit) | 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). |
| Presence of bubbles | week 2 (Colonoscopy visit) | 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). |
| Quality of colon cleansing | week 2 (Colonoscopy visit) | 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. |
| Need for washing tools during colonoscopy | week 2 (Colonoscopy visit) | 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. |
| Cecal intubation rate | week 2 (Colonoscopy visit) | Cecal intubation rate. The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete. |
| Cecal intubation time | week 2 (Colonoscopy visit) | Cecal intubation time. Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus. |
| Endoscope removal time | week 2 (Colonoscopy visit) | 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. |
| Requires repeat colonoscopy due to poor preparation | week 2 (Colonoscopy visit) | 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 |
| Adherence to the intake of the preparation | week 2 (Colonoscopy visit) | 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). |
| Ease of taking the preparation | week 2 (Colonoscopy visit) | Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire). |
| Palatability of the preparation | week 2 (Colonoscopy visit) | Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire). |
| Willingness to repeat the intake of the preparation | week 2 (Colonoscopy visit) | Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire). |
| Overall satisfaction with the intake of the preparation | week 2 (Colonoscopy visit) | 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). |
| Endoscopist's satisfaction with the cleaning of faecal remains and bubbles | week 2 (Colonoscopy visit) | 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). |
| Rate of adverse events | week 2 (Colonoscopy visit) and week 4 (visit 2) | 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). |
Countries
Spain
Contacts
CONTACTMaria Pellisé
CONTACTJudit Pich
Outcome results
None listed