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

August 24, 2011 updated by: Mashhad University of Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

August 25, 2011

Last Update Submitted That Met QC Criteria

August 24, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUMS-89619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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