Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000346673
Ethics application status
Approved
Date submitted
23/03/2014
Date registered
1/04/2014
Date last updated
1/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of the amount of perioperative fluid given in septorhinoplasty surgery on postoperative edema
Scientific title
The effects of the amount of perioperative fluid given to patients undergoing elective septorhinoplasty surgery on postoperative edema
Secondary ID [1] 284312 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fluid treatment and edema in septorhinoplasty 291462 0
Condition category
Condition code
Anaesthesiology 291830 291830 0 0
Other anaesthesiology
Surgery 291831 291831 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Septorhinoplasty surgery follow-up forms of patients were retrospectively obtained for duration of surgery, patient age, height, weight and other demographic characteristics, induction and maintenance used in anesthetics during the procedure, perioperative systolic and diastolic arterial pressures and heart rate, and the perioperative amount of fluid given. Edema and ecchymosis score at 1 hour, 24 Hours, 7 days and 10 days were obtained. The degree of edema was assessed by 4 degree scale and ecchymosis was assessed by 5 degree scale. This information was used to determine any relationship between the amount of perioperative fluid given and the occurrence and severity of edema and ecchymosis after surgery.
Intervention code [1] 289034 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291749 0
Edema at 1 hour and 24 hours post surgery assessed by 4 degree scale.
Timepoint [1] 291749 0
At 1 hour and 24 hours post surgery
Primary outcome [2] 291788 0
ecchymosis at 1 hour and 24 hours post surgery assessed by 5 degree scale.
Timepoint [2] 291788 0
at 1 hour and 24 hours post surgery
Secondary outcome [1] 307408 0
Edema at 7 and 10 days post surgery assessed by 4 degree scale.
Timepoint [1] 307408 0
At 7 days and 10 days post surgery
Secondary outcome [2] 307541 0
Ecchymosis at 7 and 10 days post surgery assessed by 5 degree scale.
Timepoint [2] 307541 0
at 7 and 10 days post surgery

Eligibility
Key inclusion criteria
patients undergoing septorhinoplasty surgery with ASA(american society of anesthesiology) score 1-2.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients treated with nonsteroidal anti-inflammatory drugs and corticosteroids perioperatively.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
1/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5918 0
Turkey
State/province [1] 5918 0
istanbul

Funding & Sponsors
Funding source category [1] 288952 0
Self funded/Unfunded
Name [1] 288952 0
Country [1] 288952 0
Primary sponsor type
Individual
Name
veysel erden
Address
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country
Turkey
Secondary sponsor category [1] 287632 0
None
Name [1] 287632 0
Address [1] 287632 0
Country [1] 287632 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
perioperative fluid treatment effects on postoperative edema and ecchymosis in patients undergoing septorhinoplasty surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47166 0
A/Prof veysel erden
Address 47166 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 47166 0
Turkey
Phone 47166 0
+902124590000
Fax 47166 0
Email 47166 0
[email protected]
Contact person for public queries
Name 47167 0
Dr CIHAN GULER
Address 47167 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 47167 0
Turkey
Phone 47167 0
+90 212 459 68 55
Fax 47167 0
Email 47167 0
[email protected]
Contact person for scientific queries
Name 47168 0
Dr CIHAN GULER
Address 47168 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 47168 0
Turkey
Phone 47168 0
+90 212 459 68 55
Fax 47168 0
Email 47168 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.