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Trial registered on ANZCTR


Registration number
ACTRN12620001327976
Ethics application status
Approved
Date submitted
15/09/2020
Date registered
8/12/2020
Date last updated
2/07/2021
Date data sharing statement initially provided
8/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of using vasopressin at the time of removal of ovarian endometriosis cyst on a woman's egg count and endometriosis-related quality of life.
Scientific title
Effect of vasopressin hydrodissection technique in laparoscopic excision of ovarian endometriomas on ovarian reserve as measured by Anti-Mullerian Hormone levels and endometriosis-related quality of life.
Secondary ID [1] 301392 0
Nil known
Universal Trial Number (UTN)
U1111-1258-2501
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 319066 0
Condition category
Condition code
Surgery 317017 317017 0 0
Surgical techniques
Reproductive Health and Childbirth 317018 317018 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consenting patients who have been randomly allocated to the treatment group will undergo laparoscopic excision of their endometriosis cyst (endometrioma) using the vasopressin hydrodissection (VIT) technique. Following incision and drainage of the cyst content, diluted vasopressin (0.5mL per 100mL normal saline) is injected into the interface/plane between the endometrioma and the ovarian parenchyma, for the purpose of hydrodissection. The endometrioma is then separated from the ovarian parenchyma using standard 'stripping' technique, and haemostasis is checked and carried out either by bipolar diathermy or ovarian suturing, as per standard surgical practice. Based on current literature and anecdotal data, the anticipated duration of vasopressin hydrodissection will be less than the standard technique; the extent of this will depend on the size of the endometrioma and surgical factors such as bleeding. All procedures will be carried out at St George Private Hospital by laparoscopic surgeons affiliated with the Sydney Women's Endosurgery Centre (SWEC); all of whom have undergone formal advanced surgical training with at least 10 years of surgical experience. All surgeries will be recorded via the laparoscopic camera and the film reviewed by an independent surgeon who is not involved in the surgery to avoid bias.
Intervention code [1] 318598 0
Treatment: Surgery
Comparator / control treatment
Consenting patients who have been randomly allocated to the control group will undergo laparoscopic excision of their endometrioma using the current standard practice of "ovarian cyst stripping". Following incision and drainage of the cyst content, the interface/plane between the endometrioma and the ovarian parenchyma is identified visually and the cyst wall is manually 'stripped' from the ovary. Haemostasis is checked and carried out either by bipolar diathermy or ovarian suturing, as per standard surgical practice. All procedures will be carried out at St George Private Hospital by laparoscopic surgeons affiliated with the Sydney Women's Endosurgery Centre (SWEC); all of whom have undergone formal advanced surgical training with at least 10 years of surgical experience. All surgeries will be recorded via the laparoscopic camera and the film reviewed by an independent surgeon who is not involved in the surgery to avoid bias.
Control group
Active

Outcomes
Primary outcome [1] 325127 0
Anti-Mullerian Hormone level serum assay
Timepoint [1] 325127 0
Baseline, 3 months, 6 months (primary timepoint) and 9 months post surgery
Secondary outcome [1] 386966 0
Quality of life assessed using the EHP-5 Questionnaire
Timepoint [1] 386966 0
Baseline, and at 3 and 6 months post surgery
Secondary outcome [2] 386967 0
Number of diathermy events via review of laparoscopic video
Timepoint [2] 386967 0
At time of surgery
Secondary outcome [3] 389630 0
Duration of endometrioma excision via review of laparoscopic video
Timepoint [3] 389630 0
At time of surgery

Eligibility
Key inclusion criteria
Women undergoing laparoscopic removal of endometrioma.
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who have significant medical conditions such as: hypertension, cardiac disease, diabetes mellitus, severe renal or hepatic disease; or women who have previously participated in this trial; or those with hypersensitivity to vasopressin.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation using GraphPad Prism version 8.1.2.
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
Hypothesising that the mean relative reduction in the serum AMH level at the 3-month post-operative time-point in the control group to be 20% (Salihoglu et al, 2016), 17 patients in each arm would be required to have an 80% power to detect a significant difference using the Student’s t-test (two-sided, a=0.05), assuming a 10% mean relative reduction in serum AMH level in the VIT group. Standard deviations for both groups were assumed to be 0.1. To account for any potential post-randomization drop-outs, the sample size was increased by ~20% for each arm, i.e. 20 patients in each arm.

Continuous variables, such as AMH levels, diathermy events will be analysed using the Student’s t-test or analysis of variance with parametric or non-parametric tests. Categorical variables, will be analysed using the Fisher’s exact test. Data analysis will be performed using the GraphPad Prism version 8.1.2.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/12/2020
Actual
18/12/2020
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
2/05/2022
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17540 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 31274 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 305833 0
Charities/Societies/Foundations
Name [1] 305833 0
Sydney Women's Endosurgery Centre
Country [1] 305833 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Sydney Women's Endosurgery Centre
Address
Sydney Women's Endosurgery Centre
1 South Street
Kogarah
NSW 2217
Country
Australia
Secondary sponsor category [1] 306278 0
None
Name [1] 306278 0
N/A
Address [1] 306278 0
N/A
Country [1] 306278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306098 0
IVFAustralia Ethics Committee
Ethics committee address [1] 306098 0
IVFAustralia
2/176 Pacific Hwy
Greenwich
NSW 2065
Ethics committee country [1] 306098 0
Australia
Date submitted for ethics approval [1] 306098 0
23/09/2020
Approval date [1] 306098 0
26/10/2020
Ethics approval number [1] 306098 0

Summary
Brief summary
Endometriosis is a common inflammatory condition affecting women during their reproductive years, with potentially debilitating sequelae in the form of subfertility and chronic pain. Endometriomas are common, occurring in up to 44% of endometriosis cases. Surgical cyst excision is the mainstay treatment for endometriomas, however surgery is often detrimental to ovarian reserve. Conventional technique using manual stripping of endometriotic cyst from the ovarian cortex is commonly associated with inadvertent removal of healthy ovarian tissue. Therefore, current standard surgical treatment of endometriomas carries the caveat of further contributing to the fertility burden of patients, in whom ovarian reserve might already be compromised.

A surgical technique using vasopressin has been shown to result in reduction in the need for bipolar diathermy in several small studies. This promising benefit of VIT also appeared to improve post-surgery ovarian reserve in one study. However, the data on the proposed benefits of this technique remains limited in the literature.

Therefore, given the clear need for a less damaging surgical approach than standard approaches and the dearth in the literature of evidence of the efficacy of the use of vasopressin for the excision of endometrioma, we seek to elucidate the purported usefulness of this technique for the treatment of endometrioma and its potential benefit on ovarian reserve and endometriosis-related quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102698 0
Dr Dave Listijono
Address 102698 0
Sydney Women's Endosurgery Centre
1 South St
Kogarah NSW 2217
Country 102698 0
Australia
Phone 102698 0
+61 2 95537411
Fax 102698 0
Email 102698 0
dave.listijono@gmail.com
Contact person for public queries
Name 102699 0
Dave Listijono
Address 102699 0
Sydney Women's Endosurgery Centre
1 South St
Kogarah NSW 2217
Country 102699 0
Australia
Phone 102699 0
+61 1300498448
Fax 102699 0
Email 102699 0
dave.listijono@gmail.com
Contact person for scientific queries
Name 102700 0
Dave Listijono
Address 102700 0
Sydney Women's Endosurgery Centre
1 South St
Kogarah NSW 2217
Country 102700 0
Australia
Phone 102700 0
+61 1300498448
Fax 102700 0
Email 102700 0
dave.listijono@gmail.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9170Informed consent form  dave.listijono@gmail.com



Results publications and other study-related documents

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