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

Early Phase 1UnknownNCT01413659

Mashhad University of Medical Sciences150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

150

Conditions

Postoperative Wound Infection

Interventions

SymbioticBIOLOGICAL

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

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 15 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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