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Trial registered on ANZCTR


Registration number
ACTRN12614001031651
Ethics application status
Approved
Date submitted
11/09/2014
Date registered
25/09/2014
Date last updated
25/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of position modification on Intra-ocular pressure, during Robotic Assisted Laparoscopic Radical Prostatectomy - A Randomized control study.
Scientific title
The effect of "Modified Z" Trendelenburg Positioning on Intra-ocular pressure, during Robotic Assisted Laparoscopic Radical Prostatectomy - A Randomized control study.
Secondary ID [1] 285323 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intra ocular pressure change, during long head down positioning - which may lead to diminish venous drainage, reduce oxygenation and nerve compression that may result in ocular complication (visual loss). 293045 0
Prostate cancer 293132 0
Condition category
Condition code
Surgery 293318 293318 0 0
Other surgery
Anaesthesiology 293356 293356 0 0
Anaesthetics
Cancer 293357 293357 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We change the patient's position during robotic assisted laparoscopic radical prostatectomy by using the standard head down trendelenburg position with elevating the head and shoulder to horizontal level and named it; "Modified Z" Trendelenburg position. IOP, blood pressure and endotracheal Co2 - measured at the induction of anaesthesia in supine, before positioning, head down, after that group 1 patients have thier head and shoulders in modified horizontal position. All patients will have those parameters checked also after pneumo-peritoneum and every 30 minutes, at the end of the operation all patients will be in horizontal supine position, with IOP checked at cease of pneumo-peritoneum, and before awakening. The surgery was not changed as a result of the positioning modification.
Intervention code [1] 290235 0
Prevention
Intervention code [2] 290272 0
Treatment: Surgery
Comparator / control treatment
Patients in the control group, went through the operation in the standard trendelenburg position; head down 23 degrees.
Control group
Active

Outcomes
Primary outcome [1] 293147 0
Intra Ocular pressure was measured in anasthesised patients, using a hand-held tonometer (TONO-PEN AVIATM, Tonometer. Reichert).
Timepoint [1] 293147 0
Intra ocular pressure - measure at the start of anaesthesia, each time the positioning changes and every 30 minute during the operation, until cease of anaesthesia.
Secondary outcome [1] 310452 0
Blood pressure was monitored and recorded by the anasthetic mechine, using blood pressure cuff at the left patient's arm.
Timepoint [1] 310452 0
Blood pressure, measure at the start of anaesthesia, each time the positioning changes and every 30 minute during the operation, until cease of anaesthesia.

Eligibility
Key inclusion criteria
All patients schedule for robotic radical prostatectomy.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Eye operation in the last 3 weeks

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
8/10/2013
Date of last participant enrolment
Anticipated
Actual
7/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2978 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 8690 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 289944 0
Self funded/Unfunded
Name [1] 289944 0
Country [1] 289944 0
Primary sponsor type
Individual
Name
Associate Prof, Celi Varol
Address
Macquarie University hospital
Urology Clinics
2 Technology place
North Ryde
2109 NSW
Country
Australia
Secondary sponsor category [1] 288634 0
None
Name [1] 288634 0
None
Address [1] 288634 0
None
Country [1] 288634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291658 0
Human Research Ethics Committee, Macquarie University.
Ethics committee address [1] 291658 0
Research Office
Level 3, Research Hub, Building C5C East
Macquarie University
NSW 2109 Australia
Ethics committee country [1] 291658 0
Australia
Date submitted for ethics approval [1] 291658 0
Approval date [1] 291658 0
27/08/2013
Ethics approval number [1] 291658 0
5201300343

Summary
Brief summary
We modify the positioning of patients going under robot-assisted laparoscopic radical prostatectomy, with head and shoulder in horizontal positioning and compare their intra ocular pressure to patients in standard position; 23 degree head-down trendelenburg.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51394 0
A/Prof Celi Varol
Address 51394 0
Macquarie University Hospital.
2 Technology place
North Ryde
NSW 2109
Country 51394 0
Australia
Phone 51394 0
+61 2 4721 8383
Fax 51394 0
Email 51394 0
[email protected]
Contact person for public queries
Name 51395 0
Orit Raz
Address 51395 0
Macquarie University Hospital.
2 Technology place
North Ryde
NSW 2109
Country 51395 0
Australia
Phone 51395 0
+61 4 81410212
Fax 51395 0
Email 51395 0
[email protected]
Contact person for scientific queries
Name 51396 0
Orit Raz
Address 51396 0
Macquarie University Hospital.
2 Technology place
North Ryde
NSW 2109
Country 51396 0
Australia
Phone 51396 0
+61 4 81410212
Fax 51396 0
Email 51396 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.