Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery
Overview
The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: December 2012
Interventions
- Biological: Symbiotic
- Oral symbiotic every 8 h since 2 days before operation; Symbiotic resumes postoperatively on day +2 until day +4 for a total of 4 d of treatment (12 doses).
Arms, Groups and Cohorts
- Experimental: Symbiotic
- Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host
Clinical Trial Outcome Measures
Primary Measures
- Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.
- Time Frame: 15 months
Secondary Measures
- The incidence of postoperative infection including surgical site infections (SSIs) and distant-site infections after elective colorectal surgery in patients whether or not receiving pre-operative symbiotic conditioning.
- Time Frame: 15 months
Participating in This Clinical Trial
Inclusion Criteria
1. Both genders 2. More than 14 years old 3. Candidate for elective colorectal surgery Exclusion Criteria:
1. Denied written informed consent, 2. Severe neutropenia, and 3. Critically ill condition 4. Not meeting inclusion criteria
Gender Eligibility: All
Minimum Age: 14 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Mashhad University of Medical Sciences
- Provider of Information About this Clinical Study
- HamidReza Naderi, Imam Reza General Hospital – Surgical Oncology Research Center (SORC)
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