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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000903987
Ethics application status
Approved
Date submitted
11/06/2020
Date registered
14/09/2020
Date last updated
14/09/2020
Date data sharing statement initially provided
14/09/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Prevalence and severity of endometriosis at laparoscopic treatment of tubal ectopic pregnancy
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Scientific title
Prevalence and severity of endometriosis at laparoscopic treatment of tubal ectopic pregnancy
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Secondary ID [1]
301050
0
None
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Universal Trial Number (UTN)
U1111-1250-5439
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
317103
0
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Ectopic pregnancy
317104
0
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Condition category
Condition code
Reproductive Health and Childbirth
315267
315267
0
0
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
315268
315268
0
0
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Fetal medicine and complications of pregnancy
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Surgery
316051
316051
0
0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Eligible patients will be invited to participate in the study by the Acute Gynaecology Unit consultant or Receiving Gynaecology registrar or resident.
Interested participants are provided a copy of the Patient Information and Consent Form (PICF) to review and consent if they wish to proceed. Initial patient data about risk factors for ectopic pregnancy and symptoms of endometriosis is collected by the Acute Gynaecology Unit team member pre-operatively using the standardised hard-copy or electronic (Survey Monkey) questionnaire.
Patients who choose not to participate will not be disadvantaged in any way with regard to their medical care.
Consenting participants will undergo the laparoscopic treatment of ectopic pregnancy of their choice (salpingectomy or salpingotomy) as well as scoring for endometriosis using the revised American Fertility Society classification of endometriosis (r-AFS). Other laparoscopic findings will also be recorded e.g. adhesions including Fitz-Hugh-Curtis Syndrome.
The intra-operative questionnaire will be completed by the lead surgeon immediately following the procedure, in the operating theatre or in the theatre recovery area. Questions to be completed are 1-23 of the Intra-operative Questionnaire, which includes the r-AFS.
As per current practice, participants will not be consented to surgical treatment of endometriosis in the same procedure unless this is discussed pre-operatively with the patient and surgical team involved on a case-by-case basis and deemed appropriate.
Both questionnaires (patient and intra-operative) are designed specifically for this particular study.
Once informed consent has been obtained, each participant will be allocated a trial number. All the information collected (including data collected using Survey Monkey) will be de-identified and securely stored in a password-protected database, from which analysis will take place. Data entry will occur concurrently with recruitment and we expect data entry to be finalised 1-2 months after recruitment has completed. The database will be retained for 7 years after completion of the study then deleted.
Duration of treatment for each participant will be 24-48 hours.
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Intervention code [1]
317355
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
323510
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To determine the prevalence of endometriosis in women at the time of laparoscopic treatment of tubal ectopic pregnancy
This will be assessed by use of:
-intra-operative questionnaire in conjunction with the
-patient questionnaire
(please see other sections of this form for further details)
These questionnaires have been designed specifically for this study.
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Assessment method [1]
323510
0
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Timepoint [1]
323510
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Immediate, ie, assessed at the time of laparoscopic treatment
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Primary outcome [2]
324511
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To determine the severity of endometriosis in women at the time of laparoscopic treatment of tubal ectopic pregnancy
This will be assessed by use of:
-intra-operative questionnaire in conjunction with the
-patient questionnaire
(please see other sections of this form for further details)
These questionnaires have been designed specifically for this study.
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Assessment method [2]
324511
0
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Timepoint [2]
324511
0
Immediate, ie, assessed at the time of laparoscopic treatment
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Secondary outcome [1]
382104
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To determine the prevalence and severity of endometriosis-related infertility (defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse) in patients diagnosed with tubal ectopic pregnancy and proceeding to laparoscopic treatment. This will be ascertained using patient questionnaire.
All questionnaires in this study have been designed specifically for this study. Please see attached
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Assessment method [1]
382104
0
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Timepoint [1]
382104
0
Immediate, ie, assessed at the time of laparoscopic treatment
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Secondary outcome [2]
384191
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To compare the prevalence and severity of endometriosis in patients with and without risk factors for tubal ectopic pregnancy. This will be determined by the senior surgeon completing the intra-operative questionnaire and scoring for endometriosis using the revised American Fertility Society classification of endometriosis (r-AFS).
All questionnaires in this study have been designed specifically for this study. Please see attached
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Assessment method [2]
384191
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Timepoint [2]
384191
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Immediate, ie, assessed at the time of laparoscopic treatment
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Secondary outcome [3]
384844
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To determine the prevalence and severity of endometriosis-related pain in patients diagnosed with tubal ectopic pregnancy and proceeding to laparoscopic treatment. This will ascertained using the patient questionnaire which uses a visual rating scale (ie: no pain, some pain, severe pain)
All questionnaires in this study have been designed specifically for this study. Please see attached
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Assessment method [3]
384844
0
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Timepoint [3]
384844
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Immediate, ie, assessed at the time of completing patient questionnaire
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Eligibility
Key inclusion criteria
All women presenting to the Royal Women’s Hospital (Women’s Emergency Centre, Early Pregnancy Assessment Centre, or transferred from another hospital), diagnosed with tubal ectopic pregnancy, who are clinically stable and suitable for laparoscopic surgery.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Non-tubal ectopic pregnancy
• Unable to understand and fully comprehend consent information
• Non consent
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Analysis of the primary hypothesis will involve using the one-sample binomial test to compare the study endometriosis rate to the population prevalence of 10%. Comparison of categorical outcomes such as presence or absence of endometriosis will be performed using Chi squared tests, while comparing continuous variables such as pain and various scales in the questionnaire measures using t-tests. If the data does not have a normal distribution, non-parametric tests such as the Mann Whitney U test will be used. P value of <0.05 will be considered significant. Logistic regression will be used to model the effects of other ectopic risk factors and their interaction with the presence of endometriosis. The study group will also be dichotomised to those with and without risk factors for ectopic pregnancy and the rates of endometriosis compared.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/10/2020
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Actual
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Date of last participant enrolment
Anticipated
19/10/2021
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Actual
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Date of last data collection
Anticipated
19/10/2021
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Actual
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Sample size
Target
66
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
16486
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The Royal Women's Hospital - Parkville
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Recruitment postcode(s) [1]
30036
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3052 - Parkville
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Funding & Sponsors
Funding source category [1]
305492
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Hospital
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Name [1]
305492
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The Royal Women's Hospital
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Address [1]
305492
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The Royal Women's Hospital
Parkville
Victoria
3052
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Country [1]
305492
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Australia
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Primary sponsor type
Individual
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Name
Dr Jennifer Dean
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Address
The Royal Women's Hospital
Parkville
Victoria
3052
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Country
Australia
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Secondary sponsor category [1]
305889
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None
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Name [1]
305889
0
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Address [1]
305889
0
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Country [1]
305889
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305804
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The Royal Women's Hospital Research Committee
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Ethics committee address [1]
305804
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Royal Women's Hospital
Parkville
Victoria
3052
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Ethics committee country [1]
305804
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Australia
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Date submitted for ethics approval [1]
305804
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17/03/2020
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Approval date [1]
305804
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10/06/2020
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Ethics approval number [1]
305804
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Summary
Brief summary
Summary of proposed research
The investigators propose a prospective cohort study to determine the prevalence and severity of endometriosis in women at the time of laparoscopic treatment of tubal ectopic pregnancy. We hypothesise that women undergoing laparoscopic treatment of ectopic pregnancy are more likely to have concurrent endometriosis than the reported overall prevalence of endometriosis in reproductive-aged women of 10%. Suitable patients will be asked and supported to complete a pre-operative questionnaire regarding their general gynaecological health and symptoms of endometriosis and surgeons will complete a questionnaire regarding their surgical findings and grade endometriosis, if present, according to revised American Fertility Society classification of endometriosis.
Ethical implications of research
The investigators can think of two ethical implications of the research project:
1. Diagnosis of endometriosis as a result of participation in this research study may make endometriosis a pre-existing condition for the application and purchase of insurance (e.g. private health insurance or income protection insurance) in the future by the participant.
2. Diagnosis but non-treatment of endometriosis at the time of laparoscopic treatment of ectopic pregnancy. This may make a repeat laparoscopy and treatment of endometriosis necessary. The investigators believe that the safety and benefits of concurrent laparoscopic treatment of endometriosis and ectopic pregnancy has not been established and therefore cannot be part of research protocol.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
101654
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Dr Jennifer Dean
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Address
101654
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The Royal Women's Hospital
Parkville
Victoria
3052
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Country
101654
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Australia
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Phone
101654
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+61 03 83452000
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Fax
101654
0
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Email
101654
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[email protected]
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Contact person for public queries
Name
101655
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Dr Jennifer Dean
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Address
101655
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The Royal Women's Hospital
Parkville
Victoria
3052
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Country
101655
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Australia
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Phone
101655
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+61 03 83452000
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Fax
101655
0
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Email
101655
0
[email protected]
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Contact person for scientific queries
Name
101656
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Dr Jennifer Dean
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Address
101656
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The Royal Women's Hospital
Parkville
Victoria
3052
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Country
101656
0
Australia
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Phone
101656
0
+61 03 83452000
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Fax
101656
0
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Email
101656
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7655
Ethical approval
379649-(Uploaded-25-06-2020-20-52-56)-Study-related document.pdf
7656
Study protocol
379649-(Uploaded-25-06-2020-20-54-13)-Study-related document.docx
7657
Informed consent form
379649-(Uploaded-25-06-2020-20-55-08)-Study-related document.docx
7658
Other
Patient questionnaire
Patient survey Intra-op survey for surgeons
379649-(Uploaded-11-06-2020-10-29-20)-Study-related document.pdf
8198
Other
Surgeon questionnaire
Patient survey Intra-op survey for surgeons
379649-(Uploaded-11-06-2020-10-30-25)-Study-related document.pdf
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.
Download to PDF