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

This study is not yet open for participant recruitment.

Verified July 2011 by Mashhad University of Medical Sciences

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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 8, 2011
Last Updated Date	August 24, 2011
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 9, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01413659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 24, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 9, 2011)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 0
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Postoperative Wound Infection
Intervention ^ICMJE	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).
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	February 2013
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Both genders More than 14 years old Candidate for elective colorectal surgery Exclusion Criteria: Denied written informed consent, Severe neutropenia, and Critically ill condition Not meeting inclusion criteria
Gender	Both
Ages	14 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01413659
Other Study ID Numbers ^ICMJE	MUMS-89619
Has Data Monitoring Committee	Not Provided
Responsible Party	HamidReza Naderi, Imam Reza General Hospital - Surgical Oncology Research Center (SORC)
Study Sponsor ^ICMJE	Mashhad University of Medical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mashhad University of Medical Sciences
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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