None listed
Conditions
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.
Interventions
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.
Sponsors
Eligibility
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.
Exclusion criteria
• Non-tubal ectopic pregnancy • Unable to understand and fully comprehend consent information • Non consent