Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Other | Patients in reproductive age, who will undergo elective surgery for endometriosis. |
|
| Control arm | Other | Women in reproductive age, without endometriosis, as control group for secondary objective 1 and 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fusobacterium detection | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis | At surgical intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis | At surgical intervention | |
| Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled | At preoperative visit |
Not provided
Inclusion Criteria for study group:
Inclusion Criteria for control group:
Exclusion Criteria for both groups:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elvia Malo | Contact | +390456014854 | ricerca.clinica@sacrocuore.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Sacro Cuore Don Calabria di Negrar | Negrar | Verona | Italy |
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating 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 |
| 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 |
| D000091662 | Genital Diseases |