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Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery

Early Phase 1
Conditions
Postoperative Wound Infection
Interventions
Biological: Symbiotic
Registration Number
NCT01413659
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SymbioticSymbioticSymbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host
Primary Outcome Measures
NameTimeMethod
Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.15 months
Secondary Outcome Measures
NameTimeMethod
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.15 months
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