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)

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.