Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT02396017
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: Centro Hospitalar Lisboa Ocidental
• Public title: Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy
• Scientific title: Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy Is Timing of Preparation for Capsule Endoscopy the Key for the Best Small-bowel Cleansing?
• Date of first enrolment: March 2015
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02396017
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
• Phase: Phase 4

Countries of recruitment

Portugal

Contacts

• Name: Pedro Magalhães-Costa, MD

• Name: Pedro Magalhães-Costa, MD

• Name: Cristina Chagas, MD
• Affiliation: Gastroenterology Department, Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental

Key inclusion & exclusion criteria

Inclusion Criteria:

- All adult patients referred to our institution for CE during the study period

Exclusion Criteria:

- inpatients, bedridden, patients with clinical evidence of active bleeding, past
history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel
perforation (suspected or confirmed), use of oral iron replacement therapy, severe
cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any
components of the preparation, patients that didn't complete the preparation
protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined
by the visualization of the mucosa from the duodenal bulb to the cecum), patients
enrolled in other clinical studies and patients who didn't signed informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bowel Preparation

Intervention(s)

Drug: Polyethylene Glycol

Device: Capsule endoscopy

Primary Outcome(s)

Small-bowel cleanliness [Time Frame: at the end of capsule endoscopy exploration]

Secondary Outcome(s)

The number of all the observed lesions [Time Frame: at the end of capsule endoscopy exploration]

The clinical tolerance questionnaire [Time Frame: at the end of capsule endoscopy exploration]

The transit time [Time Frame: at the end of capsule endoscopy exploration]

Secondary ID(s)

SPLIT-PEG-CE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors