Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.
- Conditions
- Colonoscopy
- Interventions
- Drug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full doseDrug: (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose
- Registration Number
- NCT05570669
- Lead Sponsor
- Societa Italiana di Endoscopia Digestiva
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 321
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description full dose (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) full dose Group A "delayed full-dose" regimen (study arm): intake of two large A sachets and 2 small B sachets from 20:30 to 22:00 the evening before the exam. Taking the remaining 2 envelopes A large e 2 small B envelopes from 10.30 pm to midnight the evening before the exam. split dose (Macrogol 4000 52,500 g + Sodium sulphate anhydrous 3,750 g + Simethicone 0,080 g) split dose Group B "split-dose" regimen (control arm): intake of two large A sachets and two small B sachets from 20.30 to 22:00 the evening before the exam. The remaining two large A envelopes and two small B envelopes will be taken 5 hours earlier than the time when the exam is scheduled on the same day as the exam.
- Primary Outcome Measures
Name Time Method Percentage of colonoscopies with adequate preparation 1 day - the day of the colonoscopy Percentage of colonoscopies with adequate preparation (according to BBPS score ≥ 2) in each colonic segment, in patient group A vs patient group B
- Secondary Outcome Measures
Name Time Method Quantity of bubbles 1 day - the day of the colonoscopy Quantity of bubbles and / or foam according to IBS, in patient group A vs patient group B
tollerability and compliance 2 days - the day of the drug administration + the day of the colonoscopy Degree of acceptability, tolerability and compliance, by questionnaire, in the group of patients A vs the group of patients B
Trial Locations
- Locations (10)
SC Gastroenterologia ed Endoscopia Digestiva - Ospedale S. Martino
🇮🇹Belluno, Italy
Reparto di Gastroenterologia IRRCS Saverio de Bellis
🇮🇹Castellana Grotte, Bari, Italy
SSD Endoscopia digestiva - Ospedale Manerbio
🇮🇹Manerbio, Brescia, Italy
Reparto Gastroenterologia ed Endoscopia dell'Ospedale Civile San Giovanni di Dio
🇮🇹Crotone, Italy
Presidio Ospedaliero Sant'Ottone Frangipane
🇮🇹Ariano Irpino, Avellino, Italy
SC Gastroenterologia Endoscopia Digestiva. Ospedale di Baggiovara
🇮🇹Baggiovara, Modena, Italy
Chirurgia Generale AOU Policlinico Umberto I
🇮🇹Rome, Italy
S.S. Endoscopia Digestiva/ P.O. S. Jacopo
🇮🇹Pistoia, Italy
Dipartimento di scienze mediche e chirurgiche, Università di Bologna - Policlinico Sant'Orsola
🇮🇹Bologna, Italy
Servizio Centralizzato di Endoscopia Digestiva Operatoria - AOU Federico II
🇮🇹Napoli, Italy