Phase 4 Study of Comparison of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colon-rectal Resection. A Prospective Randomized Controlled Trial.
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Intestinal Cancer
Both
Intestinal Cancer
Trial Information
Phase 4 Study of Comparison of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colon-rectal Resection. A Prospective Randomized Controlled Trial.
Inclusion Criteria:
1. Outpatients
2. ≥18 yrs old,
3. Prior history of colorectal resection due to colo-rectal cancer, referred for
surveillance colonoscopy
Exclusion Criteria:
1. Inpatients
2. Emergency Colonoscopy
3. Patients with prior history of abdominal or pelvic surgery for reasons other than
colo-rectal cancer
4. Comorbidities: Congestive heart failure, history of kidney disease, history of solid
organ transplant
5. Pregnant and/or lactating women
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Outcome Measure:
quality of bowel preparation rated according to a modified Ottawa bowel preparation scale
Outcome Time Frame:
about 2 weeks after the randomization
Safety Issue:
Yes
Authority:
Italy: The Italian Medicines Agency
Study ID:
PEGOP0613
NCT ID:
NCT01887158
Start Date:
June 2013
Completion Date:
Related Keywords:
- Intestinal Cancer
- Intestinal Neoplasms
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