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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
ACTRN12615000484549
Ethics application status
Approved
Date submitted
9/02/2015
Date registered
15/05/2015
Date last updated
13/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Effect of Hydroscopic Dilatators on Pain Scores When Used Prior to Hysteroscopy
Scientific title
Evaluation of effect of hydroscopic dilatators on pain scores in women being evaluated by hysteroscopy due to gynaecologic reasons
Secondary ID [1] 286130 0
None
Universal Trial Number (UTN)
U1111-1167-0519
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical preparation before hysteroscopy due to gynaecologic reasons 294136 0
Condition category
Condition code
Anaesthesiology 294456 294456 0 0
Anaesthetics
Surgery 295054 295054 0 0
Other surgery
Reproductive Health and Childbirth 295317 295317 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Administration of osmotic hydroscopic dilatator which is made of AQUACRYL hydrogel for cervical preparation before hysteroscopy
The hydroscopic dilatator will be administered by the gynecologist taking preoperative care in the department. The patient in lithotomy position will be administered a speculum and the dilatator will be appropriately placed through cervical canal leaving the guide of the dilatator in the vagina.
It will be administered in the morning of the planned operation about 4-6 hours before the operation and will be removed just before the patient's transport to the operation room.
Intervention code [1] 291128 0
Treatment: Devices
Comparator / control treatment
Arm 2: No administration of any cervical dilatator before hysteroscopy
Control group
Active

Outcomes
Primary outcome [1] 294242 0
Preoperative and postoperative pain scores by 10 point Numeric Rating Scale
Timepoint [1] 294242 0
Preoperative 4 hours and postoperative 3 hours
Secondary outcome [1] 312864 0
Intraoperative satisfaction of the surgeon will be evaluated by 5 point rating scale 1 meaning worst and 5 meaning best
Timepoint [1] 312864 0
through the surgery (hysteroscopy)

Eligibility
Key inclusion criteria
women over 18 years old and younger than 55 years old who are planned to be evaluated by hysteroscopy due to gynecological reasons such as endometrial polyp, hyperplasia accepting to participate in the study
Minimum age
18 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
previous cervical surgery, history of cervical insufficiency, presence of cervical premalignant lesions, need for operative hysteroscopy, mental function impairment which may lead insufficient evaluation of pain score, being on chronic opiod medication, serious systemic diseases


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will be concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequence generation was done by simple randomisation using a randomisation table created by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6639 0
Turkey
State/province [1] 6639 0

Funding & Sponsors
Funding source category [1] 290705 0
Self funded/Unfunded
Name [1] 290705 0
none
Address [1] 290705 0
none
Country [1] 290705 0
Primary sponsor type
Individual
Name
Asli Yarci Gursoy
Address
UUFUK UNIVERSITESI TIP FAKULTESI MEVLANA BULVARI (KONYA YOLU) NO: 86-88, 06520 BALGAT /ANKARA
Country
Turkey
Secondary sponsor category [1] 289397 0
None
Name [1] 289397 0
Address [1] 289397 0
Country [1] 289397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292339 0
Kirikkale University Clinical Trials Ethical Committee
Ethics committee address [1] 292339 0
KIRIKKALE UNIVERSITESI TIP FAKULTESI DEKANLIGI
71100
KIRIKKALE
Ethics committee country [1] 292339 0
Turkey
Date submitted for ethics approval [1] 292339 0
Approval date [1] 292339 0
15/09/2014
Ethics approval number [1] 292339 0
21/01

Summary
Brief summary
The study aims to compare the pain scores of patients who are planned to have hysteroscopy due to gynecological reasons dividd into two groups; one administered cervical hygroscopic dilatators before the procedure and second who were not administered any preoperative dilatators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54754 0
Dr Asli Yarci Gursoy
Address 54754 0
UFUK UNIVERSITESI TIP FAKULTESI MEVLANA BULVARI (KONYA YOLU) NO: 86-88, 06520 BALGAT /ANKARA
Country 54754 0
Turkey
Phone 54754 0
+903122044318
Fax 54754 0
Email 54754 0
asliyarci@gmail.com
Contact person for public queries
Name 54755 0
Dr Asli Yarci Gursoy
Address 54755 0
UFUK UNIVERSITESI TIP FAKULTESI MEVLANA BULVARI (KONYA YOLU) NO: 86-88, 06520 BALGAT /ANKARA
Country 54755 0
Turkey
Phone 54755 0
+903122044318
Fax 54755 0
Email 54755 0
asliyarci@gmail.com
Contact person for scientific queries
Name 54756 0
Dr Asli Yarci Gursoy
Address 54756 0
UFUK UNIVERSITESI TIP FAKULTESI MEVLANA BULVARI (KONYA YOLU) NO: 86-88, 06520 BALGAT /ANKARA
Country 54756 0
Turkey
Phone 54756 0
+903122044318
Fax 54756 0
Email 54756 0
asliyarci@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary