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

NCT ID: NCT01413659

Last Updated: 2011-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Symbiotic

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

Group Type EXPERIMENTAL

Symbiotic

Intervention Type BIOLOGICAL

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).

Interventions

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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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Imam Reza General Hospital - Surgical Oncology Research Center (SORC)

Other Identifiers

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MUMS-89619

Identifier Type: -

Identifier Source: org_study_id

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