Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001194651p
Ethics application status
Submitted, not yet approved
Date submitted
5/09/2023
Date registered
17/11/2023
Date last updated
17/11/2023
Date data sharing statement initially provided
17/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Synthetic haemostatic agent at laparoscopic ovarian cystectomy: STASIS study
Scientific title
Synthetic haemostatic agent at laparoscopic ovarian cystectomy on ovarian reserve in women aged 25 to 40 years: STASIS study
Secondary ID [1] 310537 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ovarian cyst 331358 0
ovarian reserve 331359 0
Condition category
Condition code
Reproductive Health and Childbirth 328106 328106 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Synthetic haemostatic agent RADA16 (2.5% concentration, 3ml or 5ml prefill syringe as determined by surgical team) will be applied to surgical site following ovarian cystectomy until haemostasis is achieved.and then left in place
Administrated by gynaecological surgeon
intra-operative data including adherence of intervention will be collected by the surgical team completing STASIS study data collection form at end of procedure
Intervention code [1] 326929 0
Treatment: Devices
Comparator / control treatment
No treatment or standard haemostasis management (bipolar/suture) at time of ovarian cystectomy
Control group
Active

Outcomes
Primary outcome [1] 335982 0
Pelvic ultrasound scan antral follicle count 3 months
Timepoint [1] 335982 0
Baseline (within 4 weeks of operation) and 3 months post operative
Secondary outcome [1] 426347 0
Serum Anti-Mullarian hormone
Timepoint [1] 426347 0
Baseline (within 4 weeks of operation) and 3 months post operative
Secondary outcome [2] 427384 0
readmission - patient medical records
Timepoint [2] 427384 0
30 days post-operative
Secondary outcome [3] 427385 0
return to theatre - patient medical records
Timepoint [3] 427385 0
30 days post-operative
Secondary outcome [4] 427386 0
haemorrhage (>500mls) - patient medical records
Timepoint [4] 427386 0
30 days post-operative
Secondary outcome [5] 427387 0
infection - patient medical records
Timepoint [5] 427387 0
30 days post operative
Secondary outcome [6] 427388 0
rate of allergy/adverse reaction - patient medical records
Timepoint [6] 427388 0
30 days post operative

Eligibility
Key inclusion criteria
• Age 25-40 years
• Waitlisted for elective laparoscopic ovarian cystectomy
• Primary diagnosis of unilateral or bilateral ovarian cyst as diagnosed on pelvic ultrasound scan
• Premenopausal with regular menstrual cycle
• Able to provide informed consent with or without an interpreter
Minimum age
25 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of allergy to haemostatic agents
• Post-menopausal status
• Pregnancy of lactation
• Suspicious findings for ovarian malignancy
• History of ovarian surgery (same ovary)
• Previous hysterectomy
• Active pelvic infection
• Unable to provide informed consent

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-automated software random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314738 0
Charities/Societies/Foundations
Name [1] 314738 0
AGES Grant (awaiting outcome of application)
Country [1] 314738 0
Australia
Primary sponsor type
Individual
Name
Anna Brownson (primary investigator)
Address
The Royal Women's Hospital, 20 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 317235 0
None
Name [1] 317235 0
Address [1] 317235 0
Country [1] 317235 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313749 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 313749 0
20 Flemington Road Parkville VIC 3052
Ethics committee country [1] 313749 0
Australia
Date submitted for ethics approval [1] 313749 0
06/09/2023
Approval date [1] 313749 0
Ethics approval number [1] 313749 0

Summary
Brief summary
Synthetic haemostatic agent at laparoscopic ovarian cystectomy on ovarian reserve in women aged 25 to 40 years: STASIS study

Ovarian cysts are a common gynaecological issue facing reproductive age women and the good standard surgical management is laparoscopic (key hole) ovarian cystectomy (removal of cyst). This procedure can associated with bleeding. Traditional methods to stop bleeding can damage the normal ovary (ovarian reserve) and potentially impact future fertility.
Hameostatic (blood clotting) agents are commonly used surgical products applied to the ovary after the cyst has been removed to treat bleeding in a way that minimises damage to the normal ovary. Current available products are human or animal derived.

Purastat is a similar product but completely synthetic (does not contain human or animal products), used in Gastrointestinal procedures (colonoscopy and gastroscopy) and is effective in reducing complications related to blood loss. We would like to study if applying this product to the ovary after the time of laparoscopy ovarian cystectomy is protective for ovarian reserve and future fertility.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129230 0
Dr Anna Brownson
Address 129230 0
The Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Country 129230 0
Australia
Phone 129230 0
+61451920926
Fax 129230 0
Email 129230 0
anna.brownson@thewomens.org.au
Contact person for public queries
Name 129231 0
Dr Anna Brownson
Address 129231 0
Anna Brownson, The Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Country 129231 0
Australia
Phone 129231 0
+61451920926
Fax 129231 0
Email 129231 0
anna.brownson@thewomens.org.au
Contact person for scientific queries
Name 129232 0
Dr Anna Brownson
Address 129232 0
Anna Brownson, The Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Country 129232 0
Australia
Phone 129232 0
+61451920926
Fax 129232 0
Email 129232 0
anna.brownson@thewomens.org.au

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.