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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Mashhad University of Medical Sciences.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01413659
First received: August 8, 2011
Last updated: August 24, 2011
Last verified: July 2011

August 8, 2011
August 24, 2011
September 2011
December 2012   (final data collection date for primary outcome measure)
Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01413659 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
The incidence of postoperative infection including SSIs and distant-site infections after elective colorectal surgery in patients whether or not receiving pre-operative symbiotic conditioning. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
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Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery
Not Provided

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Postoperative Wound Infection
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).
Experimental: Symbiotic
Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host
Intervention: Biological: Symbiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
14 Years and older
No
Not Provided
Not Provided
 
NCT01413659
MUMS-89619
Not Provided
HamidReza Naderi, Imam Reza General Hospital - Surgical Oncology Research Center (SORC)
Mashhad University of Medical Sciences
Not Provided
Not Provided
Mashhad University of Medical Sciences
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP