None listed
Conditions
Brief summary
This study will collect endometrial biopsies from women who are having laparoscopic surgery. During their operation, the presence +/- severity of a condition called 'endometriosis' will be graded. We hope to see whether or not there is a correlation between 'BCL6' levels on their endometrial biopsy specimen, with the presence +/- severity of endometriosis at keyhole surgery.
Interventions
Women who fulfil the selection criteria will be invited to participate in the study. Many of these women will already be planned to undertake a concurrent endometrial biopsy (which takes approximately 5 minutes), at the time of their laparoscopy (which may take anything from 30 minutes to 4 hours). If not: we will talk them through a consent form for endometrial biopsy, using the standard dilatation and curettage method. If they agree to participate, their procedure will be booked to occur during the luteal phase of their menstrual cycle (i.e. the two weeks leading up to an expected period). Patients will be asked to complete an online version of the long-form EHP-30 questionnaire pre-operatively. The EHP-30 is a reliable, validated instrument to measure the health-related quality of life of women with endometriosis. It asks participants (over the course of 30 questions) to recall how often in the last four weeks they have experienced various symptoms of endometriosis. The ‘long-form’ version includes six additional sections (using 23 questions) covering areas such as: work; relationships with children; sexual relationship(s); and feelings about the medical profession, treatment, and infertility. At their planned procedure, endometrial biopsy will be taken, using the standard dilatation and curettage method. The endometrial biopsy sample will be sent to the laboratory for analysis of the BCL6 level. Laparoscopy will be undertaken (as planned) by trained gynaecologists, and the patient’s endometriosis (if present) will be scored. Clinicians will use the best-known, and most widely used, classification system for endometriosis: the revised American Society for Reproductive Medicine (r-ASRM) classification system. This involves documenting and scoring patients’ endometriotic implants (seen at laparoscopy) based on their location and size, the location and thickness of any adhesions (internal scarring), plus the extent to which the ‘Pouch of Douglas’ (the area between the uterus and bowel) is involved. Patients will then end up being classified as having either: no endometriosis; stage I (minimal); stage II (mild); stage III (moderate); or stage IV (severe) endometriosis. Operation notes will be accessed as needed, to ensure adherence to the interventions.
Sponsors
Study design
Eligibility
Inclusion criteria
- Women aged between 18 – 50yo - Women who have a regular menstrual cycle (i.e. menstrual cycle length 21 - 35 days inclusive) - Women who are already planning to undertake laparoscopy, for any indication - English speaking - Capacity and willingness to give written informed consent - Willingness to comply with the study - Willingness to have their planned procedure undertaken in the luteal phase of their menstrual cycle
Exclusion criteria
- Women aged < 18yo or > 50yo - Women with an irregular menstrual cycle (i.e. menstrual cycle length < 21 days or > 35 days) - Women who have an absolute contra-indication to endometrial biopsy, such as viable (ongoing) intra-uterine pregnancy - Women who have a relative contra-indication to endometrial biopsy, such as: active cervical or uterine infection - Women in whom undertaking an (otherwise unnecessary) endometrial biopsy may worsen a pre-existing condition (e.g. Asherman’s syndrome, intra-uterine adhesions)