- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494271
TIVA, Inhalation Anesthesia, and Surgical Site Infection
July 9, 2015 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
The purpose of this retrospective study was to evaluate the incidence of SSI after colorectal surgery under the general anesthesia by different general anesthetic technique: inhalation versus total intravenous anesthesia.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2046
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
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
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013 at SNUBH.
Description
Inclusion Criteria:
- Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013.
Exclusion Criteria:
- None
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
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Total intravenous anesthesia
Total intravenous anesthesia using propofol and remifentanil
|
|
Inhalation
Balanced inhalation anesthesia using volatile anesthetics and remifentanil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical site infection
Time Frame: Postoperative 30 day
|
Number of participants with surgical site infection
|
Postoperative 30 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative C-reactive protein
Time Frame: Postoperative 1 day
|
Plasma concentration
|
Postoperative 1 day
|
|
Segmented neutrophil count
Time Frame: Preoperaitve 1 day, postoperative 1 day
|
Segmented neutrophil count
|
Preoperaitve 1 day, postoperative 1 day
|
|
Transfusion
Time Frame: The day of operation, postoperative 30 day
|
Number of unit of transfused red blood cells
|
The day of operation, postoperative 30 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
June 17, 2015
First Submitted That Met QC Criteria
July 7, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Estimate)
July 13, 2015
Last Update Submitted That Met QC Criteria
July 9, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- SSI_anesthesia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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