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

Primary Purpose

Postoperative Wound Infection

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Symbiotic
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Wound Infection focused on measuring Colorectal surgery, Surgical site infection, Symbiotic

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Symbiotic

    Arm Description

    Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host

    Outcomes

    Primary Outcome Measures

    Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.

    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.

    Full Information

    First Posted
    August 8, 2011
    Last Updated
    August 24, 2011
    Sponsor
    Mashhad University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01413659
    Brief Title
    Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    February 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mashhad University of Medical Sciences

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Wound Infection
    Keywords
    Colorectal surgery, Surgical site infection, Symbiotic

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Symbiotic
    Arm Type
    Experimental
    Arm Description
    Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host
    Intervention Type
    Biological
    Intervention Name(s)
    Symbiotic
    Intervention Description
    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 Measure Information:
    Title
    Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.
    Time Frame
    15 months
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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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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