We do not use these products in a concrete disease. We compare the effectiveness of these products to obtain an accurate bowel cleansing before performing a capsule endoscopic study.
Conditions
Interventions
Trade Name: Citrafleet
Product Name: Citrafleet
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: SODIUM PICOSULFATE
CAS Number: 10040-45-6
Concentration unit: mg milligram(s)
Concent
Sponsors
HOSPITAL DE GALDAKAO-USANSOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 - Patients of both sexes, aged above 18 years. 2 - Have any symptom or condition for which is necessary to make a capsule endoscopy study. 3 - Patients who after being informed of the study give written consent for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1 - Coexistence of severe organic disease that contraindicate making the intestinal cleansingor presenting any medical contraindications to drinking large volumes of fluid (I. Cardiac symptomatic IRenal with CrCl <50%). 2 - contraindication or allergy to any component of the preparations (hypersensitivity to any of the ingredients of the products). 3 - Any medical contraindications included in product sheet: severe dehydration, hypermagnesemia, gastric retention, gastrointestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as appendicitis and obstruction or known or suspected gastrointestinal perforation., rhabdomyolysis as laxatives can induce this condition and may therefore exacerbate. No use in patients with active inflammatory bowel disease known, eg Crohn's disease, ulcerative colitis. Phenylketonuria. Glucose 6-phosphate dehydrogenase deficiency. 3 - In patients with suspected suffering from a bowel obstruction or fistula. 4 - Patients with cognitive impairment that makes it impossible to complete the questionnaires. 5 - Coexisting psychiatric condition that impairs the patient to answer the the questionnaires properly. 6 - Illiteracy and language problems that hinder the realization of the tests. 7 - Pregnancy. 8 - We exclude urgent capsule endoscopy explorations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of the preparation with PSMC versus the one usually used (PEG) to obtain a correct intestinal cleansing of patients undergoing capsule endoscopy study. The cleanliness level will be measured by a scale designed for this purpose.;Secondary Objective: 1 - Compare the bowel preparation tolerance between the experimental group (group taking PSMC) and control group (group taking PEG). 2 - Compare adherence to the bowel cleansing protocol between the experimental group (group taking PSMC) and control group (group taking PEG). 3 - Compare the percentage of adverse effects between the experimental group (group taking PSMC) and control group (group taking PEG). 4 - To evaluate the reproducibility of the scale that we have designed to measure intestinal cleansing.;Primary end point(s): Our main hypothesis is that the proposed protocol, based on sodium picosulfate, light magnesium oxide, anhydrous citric acid (PSMC) is more effective than the current protocol, based on polyethylene glycol (PEG), to achieve adequate bowel cleansing in patients undergoing EC to study. Define the degree of bowel cleansing in patients using a scale designed ad hoc for this study. For this purpouse we will need to include 300 patients.;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- PSMC bowel preparation is better tolerated than PEG tolerance being measured by a test designed for this purpose. 2- The degree of patient adherence to the intestinal preparation is greater when using the PSMC that when using PEG. 3- PSMC bowel preparation has a lower percentage of adverse effects than with PEG. 4- The scale we propose to assess bowel cleansing is reproducible for measuring the degree of cleanliness in studies with capsule endoscopy.;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Spain
Contacts
Public ContactOLATZ SABAS
DEPARTAMENTO DE SANIDAD DEL GOBIERNO VASCO-BIOEF
Outcome results
None listed