Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000674134
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
6/05/2019
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of patient position and intraabdominal gas used in laparoscopic hysterectomy on optic nerve sheath diameter which reflects intracranial pressure
Scientific title
Impact of pneumoperitoneum and patient position on optic nerve sheath diameter in laparoscopic hysterectomies.
Secondary ID [1] 298010 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laparoscopic hysterectomy 312578 0
Condition category
Condition code
Reproductive Health and Childbirth 311007 311007 0 0
Other reproductive health and childbirth disorders
Anaesthesiology 311008 311008 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Optic nerve sheath diameter (ONSD) will be measured at six times using ultrasound :
1. Before anesthesia
2. 10 minutes after pneumoperitoneum
3. 10 minutes after Trendelenburg position
4. 60 minutes after Trendelenburg position
5. 10 minutes after supine position
6.20 minutes after CO2 desufflation

A laparoscopic hysterectomy will be carried out by the same surgeon who has over 10 years experience in gynecologic laparoscopy
Anesthesia will be managed by the same anesthesiologists with 9 years experience
ONSD measurement will be performed by a 15-year experienced radiologist.
Intervention code [1] 314239 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319800 0
Optic nerve sheath diameter as assessed by ultrasound
Timepoint [1] 319800 0
at;
10 minutes after Trendelenburg position
60 minutes after Trendelenburg position
10 minutes after supine position
20 minutes after CO2 desufflation
Secondary outcome [1] 369572 0
Postoperative severity of nausea and vomiting (composite) assessed by a 5 point Likert scale (0 indicating no nausea and vomiting, 4 indicates severe nausea and vomiting)
Timepoint [1] 369572 0
at the postoperative 3rd hour
Secondary outcome [2] 369573 0
Postoperative headache assessed using 10 points visual analog scale ( 1 indicates no headache, 10 indicates severe headache.
Timepoint [2] 369573 0
at the postoperative 3rd hour

Eligibility
Key inclusion criteria
Female patients undergoing laparoscopic hysterectomy
Minimum age
38 Years
Maximum age
78 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previous history of ocular disease, ocular surgery, neurologic disease and transient ischemic attack,

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/03/2019
Date of last participant enrolment
Anticipated
10/05/2019
Actual
Date of last data collection
Anticipated
30/05/2019
Actual
Sample size
Target
50
Accrual to date
38
Final
Recruitment outside Australia
Country [1] 21419 0
Turkey
State/province [1] 21419 0
Istanbul

Funding & Sponsors
Funding source category [1] 302534 0
Hospital
Name [1] 302534 0
Kanuni Sultan Suleyman Hospital
Country [1] 302534 0
Turkey
Primary sponsor type
University
Name
University of Health Sciences
Address
University of Health Sciences ,Selimiye Mahallesi, Tibbiye Cd, 34668 Üsküdar/Istanbul
Country
Turkey
Secondary sponsor category [1] 302445 0
Individual
Name [1] 302445 0
Aysu Akca
Address [1] 302445 0
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Atakent Mah. Turgut Özal Cad. No:1 Küçükçekmece, Istanbul, Turkey
Country [1] 302445 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303184 0
Institutional Ethical Committee of Kanuni Education and Training Hospital
Ethics committee address [1] 303184 0
University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Atakent Mah. Turgut Özal Cad. No:1 Küçükçekmece, Istanbul, Turkey
Ethics committee country [1] 303184 0
Turkey
Date submitted for ethics approval [1] 303184 0
20/09/2018
Approval date [1] 303184 0
12/03/2019
Ethics approval number [1] 303184 0
KAEK/2019.03.76

Summary
Brief summary
We hypothesized that pneumoperitoneum and Trendelenburg position applied during laparoscopic hysterectomy would impact intracranial pressure. Optic nerve sheath diameter measured with USG reflects intracranial pressure. Therefore we are enrolling patients undergoing a laparoscopic hysterectomy in our institute and measuring optic nerve sheath diameter with a linear 13-6 megahertz probe during different stages of the surgery (eg. before and after pneumoperitoneum, before and after Trendelenburg position). The primary outcome is the change in optic nerve sheath diameter with pneumoperitoneum and Trendelenburg position. The secondary outcome is postoperative nausea and vomiting and postoperative headache.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92778 0
Dr Gulseren Yilmaz
Address 92778 0
Department of Anesthesiology & Reanimation, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey
Country 92778 0
Turkey
Phone 92778 0
+902124041500
Fax 92778 0
Email 92778 0
[email protected]
Contact person for public queries
Name 92779 0
Dr Gulseren Yilmaz
Address 92779 0
Department of Anesthesiology & Reanimation, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey
Country 92779 0
Turkey
Phone 92779 0
+902124041500
Fax 92779 0
Email 92779 0
[email protected]
Contact person for scientific queries
Name 92780 0
Dr Gulseren Yilmaz
Address 92780 0
Department of Anesthesiology & Reanimation, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey
Country 92780 0
Turkey
Phone 92780 0
+902124041500
Fax 92780 0
Email 92780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.