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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
  Purpose

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 Intervention Phase
Postoperative Wound Infection
Biological: Symbiotic
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: August 8, 2011
Last Updated: August 24, 2011
Health Authority: IRAN : Mashhad University of Medical Sciences - Vice Chancellery of Research

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

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

ClinicalTrials.gov processed this record on November 19, 2014