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
Scientific title
Prevalence and severity of endometriosis at laparoscopic treatment of tubal ectopic pregnancy
Secondary ID [1] 301050 0
None
Universal Trial Number (UTN)
U1111-1250-5439
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 317103 0
Ectopic pregnancy 317104 0
Condition category
Condition code
Reproductive Health and Childbirth 315267 315267 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 315268 315268 0 0
Fetal medicine and complications of pregnancy
Surgery 316051 316051 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 317355 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323510 0
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.
Timepoint [1] 323510 0
Immediate, ie, assessed at the time of laparoscopic treatment
Primary outcome [2] 324511 0
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.
Timepoint [2] 324511 0
Immediate, ie, assessed at the time of laparoscopic treatment
Secondary outcome [1] 382104 0
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
Timepoint [1] 382104 0
Immediate, ie, assessed at the time of laparoscopic treatment
Secondary outcome [2] 384191 0
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
Timepoint [2] 384191 0
Immediate, ie, assessed at the time of laparoscopic treatment
Secondary outcome [3] 384844 0
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
Timepoint [3] 384844 0
Immediate, ie, assessed at the time of completing patient questionnaire

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-tubal ectopic pregnancy
• Unable to understand and fully comprehend consent information
• Non consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/10/2020
Actual
Date of last participant enrolment
Anticipated
19/10/2021
Actual
Date of last data collection
Anticipated
19/10/2021
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16486 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 30036 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 305492 0
Hospital
Name [1] 305492 0
The Royal Women's Hospital
Country [1] 305492 0
Australia
Primary sponsor type
Individual
Name
Dr Jennifer Dean
Address
The Royal Women's Hospital
Parkville
Victoria
3052
Country
Australia
Secondary sponsor category [1] 305889 0
None
Name [1] 305889 0
Address [1] 305889 0
Country [1] 305889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305804 0
The Royal Women's Hospital Research Committee
Ethics committee address [1] 305804 0
Royal Women's Hospital
Parkville
Victoria
3052
Ethics committee country [1] 305804 0
Australia
Date submitted for ethics approval [1] 305804 0
17/03/2020
Approval date [1] 305804 0
10/06/2020
Ethics approval number [1] 305804 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101654 0
Dr Jennifer Dean
Address 101654 0
The Royal Women's Hospital
Parkville
Victoria
3052
Country 101654 0
Australia
Phone 101654 0
+61 03 83452000
Fax 101654 0
Email 101654 0
jennifer.dean@thewomens.org.au
Contact person for public queries
Name 101655 0
Dr Jennifer Dean
Address 101655 0
The Royal Women's Hospital
Parkville
Victoria
3052
Country 101655 0
Australia
Phone 101655 0
+61 03 83452000
Fax 101655 0
Email 101655 0
jennifer.dean@thewomens.org.au
Contact person for scientific queries
Name 101656 0
Dr Jennifer Dean
Address 101656 0
The Royal Women's Hospital
Parkville
Victoria
3052
Country 101656 0
Australia
Phone 101656 0
+61 03 83452000
Fax 101656 0
Email 101656 0
jennifer.dean@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?




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.