Status:
COMPLETED
Probiotics in the Prevention of Complications After Colorectal Surgery
Lead Sponsor:
Evangelos J. Giamarellos-Bourboulis, M.D.
Collaborating Sponsors:
Aristotle University Of Thessaloniki
Conditions:
Postoperative Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Based on the need of large-scale, trials to explore the use of probiotics to reduce post-operative complication rate, a randomized controlled trial is designed to investigate the impact of a probiotic...
Detailed Description
Major colorectal surgery, i.e. surgery involving a wide colon resection and/or a very low anastomosis, remains problematic, despite great advances in medico-pharmaceutical treatment, improvement in su...
Eligibility Criteria
Inclusion
- Written informed consent
- Acceptable nutritional status and programmed for open surgery for colorectal cancer.
- Operation by the same consultant either as surgeon or as the primary assistant.
Exclusion
- Inability to provide written informed consent
- The need only for emergency or palliative surgery
- American Society of Anaesthesiologists (ASA) class of IV
- Pregnancy or lactation
- Inflammatory bowel disease
- Use of antibiotics during the last 10 days before surgery
- Recent steroid therapy or preoperative neoadjuvant chemotherapy or radiotherapy
- Pre-existing signs of bacterial \[white cell count, body temperature\] or viral infection \[hepatitis B or C, human immunodeficiency virus, cytomegalovirus\].
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT02313519
Start Date
April 1 2013
End Date
August 1 2014
Last Update
December 10 2014
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