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

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ClinicalTrials.gov Identifier: NCT01413659
Recruitment Status : Unknown
Verified July 2011 by Mashhad University of Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2011
Last Update Posted : August 25, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Postoperative Wound Infection Biological: Symbiotic Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : September 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Symbiotic
Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host
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).



Primary Outcome Measures :
  1. Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning. [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: HamidReza Naderi, Imam Reza General Hospital - Surgical Oncology Research Center (SORC)
ClinicalTrials.gov Identifier: NCT01413659     History of Changes
Other Study ID Numbers: MUMS-89619
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: July 2011

Keywords provided by Mashhad University of Medical Sciences:
Colorectal surgery
Surgical site infection
Symbiotic

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes