Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.

Colonoscopy Clinical Trial

— ERACLES  

Official title:

Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning Using a 2lt PEG-CS With Simethicone: a Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570669
• Other study ID #: ERACLES01/2020
• Status: Completed
• Phase: Phase 4
• Start date: May 25, 2021
• Est. completion date: December 28, 2021

Study information

• Verified date: September 2022
• Source: Societa Italiana di Endoscopia Digestiva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter, prospective, randomized, checked, open label, with blind evaluation, for compare the intestinal cleansing effectiveness of the regimen full-dose delayed (A) of Clensia vs split regimen (B) of Clensia, in patients undergoing endoscopy.

Description:

Enrolled patients, after providing written informed consent, are randomized to the CLENSIA preparation scheme, delayed full-dose or split-dose regimen. The delayed full-dose regimen will constitute study arm A while the split-dose regimen will constitute the control arm B.

Participants will follow a slag-free diet in the three days preceding the colonoscopy (reduction in the consumption of fruit, vegetables and legumes). On the day before the colonoscopy, patients will be able to have a normal breakfast and lunch that are both free of fiber. The dietary indications will be delivered in writing to the patient by the health staff of the center involved in the trial. From the moment the preparation begins with the intake of the product, the intake of solid foods will no longer be allowed while clear liquids of the patient's choice can be taken freely up to two hours before the colonoscopy.

The study ends for each patient with the execution of each procedure / examination planned for the visit 2 The effectiveness of the preparation in terms of intestinal cleansing is assessed blindly (by the endoscopist) using the scale (Boston Bowel Preparation Scale).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male / female patients

• outpatient, consecutively subjected to colonoscopy with an exam scheduled from 8.00 to 10.00

• Age between 18 and 75 years

• Written informed consent

Exclusion Criteria:

• Hypersensitivity and contraindications to the product under study, to the active ingredients or to any of the excipients.

Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) <30 ml / min / 1.73 m2)

• Presence of known chronic inflammatory bowel disease

• Previous digestive tract surgery

• Suspected gastrointestinal perforation

• History of congestive heart failure (NYHA class III or IV)

• Severe hepatic insufficiency or impairment (in the case of Child-Pugh Class C accurate verification of the patient's condition) indicated by transaminase values greater than 3 times the maximum normal value.

• Toxic colitis or toxic megacolon

• Suspected intestinal obstruction

• Patients enrolled in colorectal cancer screening programs

• Intestinal paralysis

• Documented electrolyte disturbances (Na, Cl, K, Ca or P outside normal limits)

• Recent symptomatic acute ischemic heart disease (<6 months). Acute myocardial infarction and recent unstable angina within six months antecedents.

• Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug, whichever is longer.

• Documented state of pregnancy ascertained through positive pregnancy test

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose
Taking the colonoscopy preparation drug (Clensia) in a single administration
• (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose
Taking the colonoscopy preparation drug (Clensia) in two stages of administration

Locations

Country	Name	City	State
Italy	Presidio Ospedaliero Sant'Ottone Frangipane	Ariano Irpino	Avellino
Italy	SC Gastroenterologia Endoscopia Digestiva. Ospedale di Baggiovara	Baggiovara	Modena
Italy	SC Gastroenterologia ed Endoscopia Digestiva - Ospedale S. Martino	Belluno
Italy	Dipartimento di scienze mediche e chirurgiche, Università di Bologna - Policlinico Sant'Orsola	Bologna
Italy	Reparto di Gastroenterologia IRRCS Saverio de Bellis	Castellana Grotte	Bari
Italy	Reparto Gastroenterologia ed Endoscopia dell'Ospedale Civile San Giovanni di Dio	Crotone
Italy	SSD Endoscopia digestiva - Ospedale Manerbio	Manerbio	Brescia
Italy	Servizio Centralizzato di Endoscopia Digestiva Operatoria - AOU Federico II	Napoli
Italy	S.S. Endoscopia Digestiva/ P.O. S. Jacopo	Pistoia
Italy	Chirurgia Generale AOU Policlinico Umberto I	Rome

Sponsors (11)

Lead Sponsor	Collaborator
Societa Italiana di Endoscopia Digestiva	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, Azienda Policlinico Umberto I, Federico II University, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Ospedale Civile San Giovanni di Dio Crotone, Ospedale di Baggiovara Modena, Ospedale di Manerbio ASST Garda, Ospedale S. Jacopo Pistoia, Ospedale S. Martino Belluno, Presidio Ospedaliero Sant Ottone Frangipane Avellino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of colonoscopies with adequate preparation	Percentage of colonoscopies with adequate preparation (according to BBPS score = 2) in each colonic segment, in patient group A vs patient group B	1 day - the day of the colonoscopy
Secondary	Quantity of bubbles	Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B	1 day - the day of the colonoscopy
Secondary	tollerability and compliance	Degree of acceptability, tolerability and compliance, by questionnaire, in the group of patients A vs the group of patients B	2 days - the day of the drug administration + the day of the colonoscopy