Status:
COMPLETED
Effect of Adding Simethicone to Split-dose Polyethylene Glycol for Bowel Preparation in a Screening Colonoscopy Setting
Lead Sponsor:
Portuguese Oncology Institute, Coimbra
Conditions:
Colo-rectal Cancer
Colonic Neoplasms
Eligibility:
All Genders
50-74 years
Phase:
NA
Brief Summary
Colonoscopy is currently accepted as the gold standard in screening, surveillance and prevention for colorectal cancer (CRC), and therefore, its quality is a major priority. The quality of colonoscop...
Detailed Description
a. Study type: Endoscopist-blinded randomized controlled trial i. Prospective inclusion of patients scheduled for a colonoscopy by nationwide CRC screening program after a positive faecal immunochemic...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- consecutive patients scheduled for colonoscopy by nationwide CRC screening program after a positive faecal immunochemical test,
- signed informed consent.
- Exclusion criteria:
- previous diagnosis of CRC,
- presence of known genetic susceptibility syndromes related with CRC,
- personal history of inflammatory bowel disease,
- presence of gastrointestinal complaints (significant changes in gastrointestinal transit in the last 6 months or evidence of gastrointestinal bleeding),
- a normal colonoscopy in the last 10 years and a normal flexible sigmoidoscopy in the last 5 years,
- known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection,
- pregnant or at risk of becoming pregnant and lactating women,
- known or suspected hypersensitivity to the active or other ingredients.
Exclusion
Key Trial Info
Start Date :
June 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2022
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT03816774
Start Date
June 15 2019
End Date
September 17 2022
Last Update
October 5 2022
Active Locations (1)
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1
Portuguese Oncology Institute - Coimbra
Coimbra, Portugal, 3001-651