NCT02494271

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,046

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
Last Updated

July 13, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

June 17, 2015

Last Update Submit

July 9, 2015

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    Number of participants with surgical site infection

    Postoperative 30 day

Secondary Outcomes (3)

  • Postoperative C-reactive protein

    Postoperative 1 day

  • Segmented neutrophil count

    Preoperaitve 1 day, postoperative 1 day

  • Transfusion

    The day of operation, postoperative 30 day

Study Arms (2)

Total intravenous anesthesia

Total intravenous anesthesia using propofol and remifentanil

Inhalation

Balanced inhalation anesthesia using volatile anesthetics and remifentanil

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013 at SNUBH.

You may qualify if:

  • Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 17, 2015

First Posted

July 10, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 13, 2015

Record last verified: 2015-07

Locations

KR(1)