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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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) 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

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