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Trial registered on ANZCTR


Registration number
ACTRN12619000433101
Ethics application status
Approved
Date submitted
12/03/2019
Date registered
18/03/2019
Date last updated
22/08/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of age and parity on the experience of relief and regret in women who have undergone hysterectomy for benign disease
Scientific title
The impact of age and parity on the experience of relief and regret in women who have undergone hysterectomy for benign disease
Secondary ID [1] 297701 0
nil known
Universal Trial Number (UTN)
U1111-1229-9586
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hysterectomy 312003 0
Condition category
Condition code
Reproductive Health and Childbirth 310568 310568 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Women who have undergone elective hysterectomy for benign disease when aged less than 51 years at the Royal Women's Hospital between 01/01/2008 - 31/07/2015 will be contacted to complete a survey. This asks about their experience of relief and regret regarding their hysterectomy as well as demographic data, medical and symptom history, current levels of stress and anxiety and personality trait. The survey will take approximately 30 minutes to complete. This survey has been self constructed with advice from gynaecologists and a psychologist as no pre-existing survey fit for our purpose existed. It does incorporate two validated questionnaires, the DASS-21, to measure depression, anxiety and stress and the 10-item neuroticism subscale of the International Personality Item Pool (IPIP-NEO) to assess the personality trait of neuroticism.
Intervention code [1] 313932 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319422 0
Regret as assessed by study-specific questionnaire
Timepoint [1] 319422 0
At least 3 and up to 11 years after hysterectomy performed.
Primary outcome [2] 319446 0
Relief as assessed by study-specific questionnaire
Timepoint [2] 319446 0
At least 3 and up to 11 years after hysterectomy
Secondary outcome [1] 368089 0
Number of all live children (biological/step/adopted) at time of hysterectomy being performed as reported in study-specific questionnaire
Timepoint [1] 368089 0
At time of hysterectomy
Secondary outcome [2] 368090 0
The rate of symptom resolution in women undergoing hysterectomy for benign disease as assessed by study specific questionnaire
Timepoint [2] 368090 0
At least 3 and up to 11 years after hysterectomy performed.
Secondary outcome [3] 368091 0
Desire for future fertility as assessed by study specific questionnaire
Timepoint [3] 368091 0
At least 3 and up to 11 years after hysterectomy performed
Secondary outcome [4] 368232 0
Level of current depression, stress and anxiety, as assessed by the DASS-21 questionnaire
Timepoint [4] 368232 0
At least 3 years and up to 11 years after hysterectomy
Secondary outcome [5] 368233 0
Level of neuroticism as a personality trait as assessed by the IPIP-NEO 10 item subscale
Timepoint [5] 368233 0
Assessed at least 3 years up to 11 years after hysterectomy
Secondary outcome [6] 368241 0
Parity, as assessed by study specific questionnaire
Timepoint [6] 368241 0
At time of hysterectomy
Secondary outcome [7] 368242 0
Reason for hysterectomy being performed as assessed by study-specific questionnaire
Timepoint [7] 368242 0
At time of hysterectomy

Eligibility
Key inclusion criteria
• All women who have undergone elective hysterectomy for benign disease in a general gynaecology unit at the Royal Women’s Hospital (Gynaecology Units 1, 2 and 3)
• Age <51 at time of surgery (this will include a range of ages for whom fertility is a possible issue and for whom fertility is not an issue and will target a mostly pre-menopausal population. With the exception of prolapse surgery the reasons for which hysterectomy is undertaken and pathologies detected differ in a menopausal group)
• Any type of hysterectomy included (total/subtotal; vaginal/ abdominal/ laparoscopic)
• Hysterectomy performed from 01/01/2008 – 31/07/2015 inclusive (as we want to allow at least 3 years of time from surgery to allow for long-term reflection on the decision)
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Indication for hysterectomy was malignancy or suspected malignancy including endometrial hyperplasia
• Hysterectomy performed as unplanned/emergency procedure
• Caesarean hysterectomy
• Non-English speaking

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
1362 women aged <51 years underwent hysterectomy from 2008 – 2015 inclusive under the three general gynaecology units at the Royal Women’s Hospital. Of the 1362 women 110 were aged <36 at the time of hysterectomy. Once those with diagnoses of endometrial hyperplasia and endometrial cancer are excluded there will approximately 1250 women eligible to participate. The mean age of those eligible to participate in this study is 43 years, with standard deviation of 4.87. Using STATA V15 a sample size of 128 participants is required to detect a 2.5 year difference (half a standard deviation) in mean age between those who do and don’t report regret regarding hysterectomy with power=0.8 and alpha=0.05. While 128 is the minimum number to assess a 2.5 year difference in age in those who regret vs don’t we would also like to be able to assess the associations and interactions of other confounders such as: age, parity, neuroticism, psychological morbidity, history of abuse, indication for hysterectomy, desire for future fertility and symptom resolution following hysterectomy using logistic regression. Using a conservative estimate that 50 observations (or participants) are required per variable examined in the logistic regression [1], a sample size of 450 participants will allow us to examine at least 9 variables for their association and interaction(s) with relief and regret. We therefore aim for a sample size of 450 participants, with 128 minimum for assessment of the primary outcome of age and regret.

At completion of the study analysis will involve comparing categorical outcomes such as presence of previous general and gynaecological conditions using Chi squared tests and comparing continuous variables such as parity and various scales in the questionnaire measures using t-tests. If the data does not have a normal distribution then a non-parametric tests such as the Mann Whitney U test will be used. We will use ordinal logistic regression modelling to assess the effects of age and parity on relief and regret in this cohort. We will use regression modelling to assess the interactions of potential variables of interest associated with relief or regret (such as neuroticism, depression, indication for hysterectomy, fertility plans, experience of abuse and symptom response to surgery). P value of <0.05 will be considered significant.

[1]Katz MH. Multivariable Analysis. Second Edtion. NY: Cambridge University Press, 2006: 81

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13367 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 25967 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302224 0
Hospital
Name [1] 302224 0
The Royal Women's Hospital
Address [1] 302224 0
Cnr Flemington Rd and Grattan St
Parkville
VIC 3052
Country [1] 302224 0
Australia
Primary sponsor type
Individual
Name
Dr Charlotte Reddington
Address
The Royal Women's Hospital
Cnr Flemington Rd and Grattan St
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 302077 0
Individual
Name [1] 302077 0
A/Prof Martin Healey
Address [1] 302077 0
The Royal Women's Hospital
Cnr Flemington Rd and Grattan St
Parkville
VIC 3052
Country [1] 302077 0
Australia
Other collaborator category [1] 280601 0
Individual
Name [1] 280601 0
Dr Claudia Cheng
Address [1] 280601 0
The Royal Women's Hospital
Cnr Flemington Rd and Grattan St
Parkville
VIC 3052
Country [1] 280601 0
Australia
Other collaborator category [2] 280602 0
Individual
Name [2] 280602 0
Dr Uri Dior
Address [2] 280602 0
The Royal Women's Hospital
Cnr Flemington Rd and Grattan St
Parkville
VIC 3052
Country [2] 280602 0
Australia
Other collaborator category [3] 280603 0
Individual
Name [3] 280603 0
A/Prof Lesley Stafford
Address [3] 280603 0
The Royal Women's Hospital
Cnr Flemington Rd and Grattan St
Parkville
VIC 3052
Country [3] 280603 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302904 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 302904 0
Locked Bag 300
Cnr Grattan St & Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 302904 0
Australia
Date submitted for ethics approval [1] 302904 0
Approval date [1] 302904 0
29/01/2019
Ethics approval number [1] 302904 0
Project 18/36

Summary
Brief summary
Hysterectomy (removal of the womb) may be performed to try and improve quality of life for women experiencing benign (non-cancerous) conditions that can cause pelvic pain, heavy bleeding and prolapse. As it is an irreversible surgery after which the woman can no longer carry a pregnancy the decision to undergo hysterectomy may be difficult for both patients and their clinicians. We are interested in how and why women make the decision to undergo hysterectomy, how it changes their quality of life and experience of symptoms, if at all, and whether it is associated with significant relief or regret. We especially want to know if age and number of children a women has had at the time of hysterectomy influence their feelings of relief and/or regret. This information will help guide women and their clinicians considering hysterectomy as an option.

We will contact women who have had a hysterectomy for benign conditions and ask them to complete a questionnaire to explore their feelings or relief and regret, and also get information about their medical history, decision making about hysterectomy, symptoms and quality of life after hysterectomy as well as current levels of stress and personality type. This information will be used to examine the relationship age and parity (number of children had) have with regret and relief after hysterectomy as well as look at other factors that influence this.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91794 0
Dr Charlotte Reddington
Address 91794 0
The Royal Women's Hospital
Cnr Grattan St and Flemington Rd,
Parkville
VIC 3052
Country 91794 0
Australia
Phone 91794 0
+61383452000
Fax 91794 0
Email 91794 0
c.reddington@gmail.com
Contact person for public queries
Name 91795 0
Dr Charlotte Reddington
Address 91795 0
The Royal Women's Hospital
Cnr Grattan St and Flemington Rd,
Parkville
VIC 3052
Country 91795 0
Australia
Phone 91795 0
+61383452000
Fax 91795 0
Email 91795 0
c.reddington@gmail.com
Contact person for scientific queries
Name 91796 0
Dr Charlotte Reddington
Address 91796 0
The Royal Women's Hospital
Cnr Grattan St and Flemington Rd,
Parkville
VIC 3052
Country 91796 0
Australia
Phone 91796 0
+61383452000
Fax 91796 0
Email 91796 0
c.reddington@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
To maintain confidentiality
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1599 0
Study protocol
Citation [1] 1599 0
Link [1] 1599 0
Email [1] 1599 0
Other [1] 1599 0
Type [2] 1601 0
Informed consent form
Citation [2] 1601 0
Link [2] 1601 0
Email [2] 1601 0
Other [2] 1601 0
Summary results
No Results