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:
Mashhad University of Medical Sciences
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
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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:
- 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
Contacts and Locations
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:
|
Surgical Wound Infection Wound Infection Infection |
Postoperative Complications Pathologic Processes Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013