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

Mashhad University of Medical Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Postoperative Wound Infection

Treatments: Biological: Symbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01413659

MUMS-89619

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 1 patient group

Symbiotic

Experimental group

Description:

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

Treatment:

Biological: Symbiotic