Colorectal DisordersNCT02494271
TIVA, Inhalation Anesthesia, and Surgical Site Infection
An observational study of Colorectal Disorders, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Colorectal Disorders
- Type of treatment
- Injection or infusion
- How many people
- 2,046 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013 at SNUBH.
Who may be able to join
- Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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.
- Conditions
- Colorectal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia | Total intravenous anesthesia using propofol and remifentanil | |
| Inhalation | Balanced inhalation anesthesia using volatile anesthetics and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Number of participants with surgical site infection
Measured: Postoperative 30 day
Secondary outcomes (3)
Postoperative C-reactive protein
Plasma concentration
Measured: Postoperative 1 day
Segmented neutrophil count
Segmented neutrophil count
Measured: Preoperaitve 1 day, postoperative 1 day
Transfusion
Number of unit of transfused red blood cells
Measured: The day of operation, postoperative 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494271
- Sponsor's protocol ID
- SSI_anesthesia
- Status last verified
- Jul 2015
- First submitted
- 17 Jun 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIVA, Inhalation Anesthesia, and Surgical Site Infection
- ClinicalTrials.gov ID
- NCT02494271
- Acronym / sponsor ID
- SSI_anesthesia
- Conditions
- Colorectal Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,046 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia | – | –Total intravenous anesthesia using propofol and remifentanil |
| Inhalation | – | –Balanced inhalation anesthesia using volatile anesthetics and remifentanil |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013 at SNUBH.
Key inclusion criteria (1 listed)
- Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical site infection
Time frame: Postoperative 30 day
Number of participants with surgical site infection
3 secondary outcomes
Postoperative C-reactive protein
Time frame: Postoperative 1 day
Segmented neutrophil count
Time frame: Preoperaitve 1 day, postoperative 1 day
Transfusion
Time frame: The day of operation, postoperative 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Disorders, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: Postoperative 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.