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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01413659
Enrollment
150
Registered
2011-08-10
Start date
2011-09-30
Completion date
2013-02-28
Last updated
2011-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Wound Infection

Keywords

Colorectal surgery, Surgical site infection, Symbiotic

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.

Interventions

BIOLOGICALSymbiotic

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).

Sponsors

Mashhad University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.15 months

Secondary

MeasureTime 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.15 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026