Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Periampullary Carcinoma Nos
Both
Periampullary Carcinoma Nos
Trial Information
Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
Inclusion Criteria:
- Patients in need of surgery for periampullary cancer
Exclusion Criteria:
- Patients submitted to periampullary surgery without pathologic confirmation of cancer
- Patients unwilling to be a part of the trial
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Mortality
Outcome Description:
Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period
Outcome Time Frame:
participants will be followed for the duration of hospital stay, an expected average of 15 days
Safety Issue:
No
Authority:
Brazil: Ethics Committee
Study ID:
09256
NCT ID:
NCT01468779
Start Date:
February 2010
Completion Date:
May 2012
Related Keywords:
- Periampullary Carcinoma Nos
- Periampullary cancer
- Surgery
- Dietary supplementation
- Nutritional assessment
- Carcinoma
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