Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001368921
Ethics application status
Approved
Date submitted
30/09/2020
Date registered
18/12/2020
Date last updated
9/01/2023
Date data sharing statement initially provided
18/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating immediate pain and post surgical recovery following laparoscopic surgery for diagnosis or treatment of endometriosis
Scientific title
Investigating immediate pain and post surgical recovery following laparoscopic surgery for diagnosis or treatment of endometriosis: a prospective cohort study.
Secondary ID [1] 302423 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N.A

Health condition
Health condition(s) or problem(s) studied:
endometriosis 319225 0
Condition category
Condition code
Surgery 317189 317189 0 0
Other surgery
Reproductive Health and Childbirth 317190 317190 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
Patients who present to our hospital and clinics and across Australia with endometriosis-associated symptoms (e.g. dysmenorrhoea, non-menstrual pelvic pain, dyspareunia, dyschezia, dysuria, subfertility etc.) undergoing a planned laparoscopy to diagnose and/or treat endometriosis will be followed up for three months post laparoscopy. Data will be collected using the National Endometriosis Clinical and Scientific Trials (NECST) Network database.
Intervention code [1] 318703 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325265 0
Our primary outcome is the change in endometriosis-associated symptoms (assessed with a 10-point visual analogue scale; VAS) including"
- Dysmenorrhoea
Timepoint [1] 325265 0
Within the first three months following laparoscopy
Primary outcome [2] 325804 0
Our primary outcome is the change in endometriosis-associated symptoms (assessed with a 10-point visual analogue scale; VAS) including:
Non menstrual pelvic pain
Timepoint [2] 325804 0
Within the first three months following laparoscopy
Primary outcome [3] 325805 0
Our primary outcome is the change in endometriosis-associated symptoms (assessed with a 10-point visual analogue scale; VAS) including:
Dyschezia
Timepoint [3] 325805 0
Within the first three months following laparoscopy
Secondary outcome [1] 387361 0
Our primary outcome is the change in endometriosis-associated symptoms (assessed with a 10-point visual analogue scale; VAS) including:
- Back pain
Timepoint [1] 387361 0
Within the first three months following laparoscopy
Secondary outcome [2] 387362 0
We will also assess changes bowel function from baseline (before surgery) using the validated COREFO questionnaire for bowel and bladder changes
Timepoint [2] 387362 0
Within the first three months following laparoscopy
Secondary outcome [3] 389194 0
Our secondary outcome is the change in non pain symtpoms commonly associated with endometriosis (assessed with a 10-point visual analogue scale; VAS) including:
-Fatigue
Timepoint [3] 389194 0
Within the first three months following laparoscopy
Secondary outcome [4] 389195 0
Our secondary outcome is the change in non pain symtpoms commonly associated with endometriosis (assessed with a 10-point visual analogue scale; VAS) including:
- Headache
Timepoint [4] 389195 0
Within the first three months following laparoscopy
Secondary outcome [5] 389196 0
We will also assess changes in bladder function from baseline (before surgery) using the validated FLUTs questionnaire
Timepoint [5] 389196 0
Within the first three months following laparoscopy

Eligibility
Key inclusion criteria
- People with endometriosis. This may be women, people who identify as non-binary, or transgender men.
- Participants being investigated for their endometriosis-related symptoms undergoing a planned surgical procedure.
- Participants fluent in spoken and written English
- Willingness to give written informed consent and willingness to participate to and comply with the study
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
- Patient known or suspected to have a malignancy
- Patients who may become distressed because of their involvement in the study

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We estimate at least 134 women in each of the superficial and deep endometriosis categories to determine a minimum clinically important difference of 10mm on a 100mm VAS for endometriosis associated pain chnages with a=0.05 and a B=0.8 as reported in previous studies in endometriosis. We will recruit 400 women to the study and this allows for a 20% drop out and capacity to report changes associated with deep or superficial disease when stratified by this classification.

Our dataset will be stratified by phenotype of endometriosis disease (superficial or deep). Paired data at baseline and follow up will be compared both within and between groups to report changes in pain to provide both common change in symptoms (measured by median or mean as required by testing for normality using the Kolmogorov-Smirnov method) and the possible outcomes (determined by range of responses). Comparison between groups will be undertaken with a Mann-Whitney U test for nonparametric data or the independent-samples one-tail t-test for parametric data, as appropriate. Paired within-group data will be compared using the Wilcoxon rank sum test for nonparametric data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
2/06/2021
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
400
Accrual to date
39
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 17699 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 17700 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 31545 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 306842 0
Hospital
Name [1] 306842 0
The Royal Hospital for Women
Country [1] 306842 0
Australia
Primary sponsor type
Hospital
Name
Royal Hospital for Women
Address
Barker Street
RANDWICK, NSW, 2031
Country
Australia
Secondary sponsor category [1] 307417 0
None
Name [1] 307417 0
Address [1] 307417 0
Country [1] 307417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307003 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 307003 0
Research Support Services
Level 2, i block
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 307003 0
Australia
Date submitted for ethics approval [1] 307003 0
18/03/2020
Approval date [1] 307003 0
03/08/2020
Ethics approval number [1] 307003 0
ERM Reference Number 62508, Monash Health Reference: RES-20-0000-258A
Ethics committee name [2] 310214 0
Bellbery Limited
Ethics committee address [2] 310214 0
123 Glen Osmond Road
Eastwood, SA, 5063
Ethics committee country [2] 310214 0
Australia
Date submitted for ethics approval [2] 310214 0
22/03/2020
Approval date [2] 310214 0
15/09/2020
Ethics approval number [2] 310214 0
2020-03-224

Summary
Brief summary
Endometriosis is a common yet under-recognised chronic disease. Endometriosis occurs when cells similar to those that line a persons uterus grow in other parts of their body, usually around the pelvis. Although endometriosis is often effectively managed, it can lead to debilitating chronic and persistent pelvic pain and compromised fertility. It can also significantly impact the social and economic participation and psychosocial health of those affected. it is estimated that 11.4% (more than 830 000) Australian people are living with endometriosis; however, delays in diagnosis and lack of definitive research on the domestic burden of disease suggest the number could be far higher.

Surgery for endometriosis is a common procedure and randomised, placebo controlled trials have shown a benefit at 6 and 12 months following surgery, with variable changes noted in these studies in the first few months. People with endometriosis frequently report a worsening of pain following their surgery, however there are no data reporting immediate outcomes, effect on menstruation or the likely changes to expect in these first few months.

Our aim is to investigate the immediate effect of surgery on people's symptoms and provide that information in publicly available forums to improve the education and understanding of how women experience symptoms in the immediate post-operative phase of care. It is important to note that we are not establishing the long-term outcomes since these are reported in other studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105714 0
Dr Blake Knapman
Address 105714 0
The Royal Hospital for Women
Barker Street
RANDWICK, NSW, 2031
Country 105714 0
Australia
Phone 105714 0
+61 427420624
Fax 105714 0
Email 105714 0
[email protected]
Contact person for public queries
Name 105715 0
Dr Blake Knapman
Address 105715 0
The Royal Hospital for Women
Barker Street
RANDWICK, NSW, 2031
Country 105715 0
Australia
Phone 105715 0
+61 293826111
Fax 105715 0
Email 105715 0
[email protected]
Contact person for scientific queries
Name 105716 0
Prof Jason Abbott
Address 105716 0
Level 1, The Royal Hospital for Women
Barker Street
RANDWICK, NSW, 2031
Country 105716 0
Australia
Phone 105716 0
+61 293826111
Fax 105716 0
Email 105716 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.