Endometriosis
Conditions
Brief summary
This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation. A control group would however be recruited for secondary objective 1 and 2. The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice.
Interventions
DIAGNOSTIC_TESTFusobacterium detection
One vaginal and one cervical swab will be collected from participants (both cases and controls) before surgery. During surgical intervention, routine biopsies of the endometriotic tissue will be done for all endometriosis types; further, small biopsies of apparently healthy endometrial tissue and of healthy peritoneum will be done, as per routine procedure. In the control group routine biopsies needed for the specific condition and small biopsies of endometrial tissue will be carried out. During these routine biopsies, a small additional quantity of tissue will be taken, which will be analyzed for the search for Fusobacterium.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for study group: * Age ≥ 18 years; * endometriosis with clinical indication for either hysteroscopy or hysterectomy; * signed informed consent to study participation and to personal data's treatment. Inclusion Criteria for control group: * need of elective gynecological surgery for causes other than endometriosis and malignancies; * indication for hysteroscopy with endometrial biopsy; * signed informed consent to study participation and to personal data's treatment.
Exclusion criteria
for both groups: * lack of signed informed consent; * Menopause * antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis | At surgical intervention |
Secondary
| Measure | Time frame |
|---|---|
| Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled | At preoperative visit |
| Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis . | At surgical intervention |
| Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis | At surgical intervention |
| Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis | At surgical intervention |
| Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis | At surgical intervention |
| Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present | At surgical intervention |
Countries
Italy
Contacts
Primary ContactElvia Malo
Outcome results
None listed