Myoma;Uterus
Conditions
Keywords
Diagnostic hysteroscopy, Fertility, Intrauterine adhesions, Myomectomy, Uterine fibroids
Brief summary
This prospective, multicenter, observational study evaluated the prevalence of intrauterine adhesions after laparoscopic or laparotomic myomectomy and investigated clinical and surgical factors associated with their occurrence. Consecutive women who underwent laparoscopic or laparotomic myomectomy were considered eligible and were approached for enrollment. Women who provided informed consent were included in the study. All included women underwent myomectomy and postoperative management according to routine clinical practice. All enrolled women underwent office diagnostic hysteroscopy three months after surgery to assess the presence of intrauterine adhesions. Clinical characteristics, surgical details of the myomectomy, and hysteroscopic findings were prospectively collected in an anonymized database.
Interventions
DIAGNOSTIC_TESTDiagnostic hysteroscopy
Diagnostic hysteroscopy performed three months after myomectomy in an office setting using a vaginoscopic approach, without cervical dilatation, with a 4.3 mm outer sheath hysteroscope (BETTOCCHI Office Hysteroscope size 5; Karl Storz, Tuttlingen, Germany). Normal saline solution was used as the uterine distension medium.
Sponsors
Università degli Studi dell'Insubria
University of Miami
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of one or more uterine myomas * Desire to preserve fertility/uterus * Myomectomy (by laparotomy or laparoscopy)
Exclusion criteria
* Adults unable to consent * Pregnant women * Prisoners * History of previous intrauterine procedures such as dilation and curettage * History of known intrauterine adhesions * History of documented pelvic inflammatory disease * History of endometritis (acute or chronic) * Hysteroscopic myomectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of intrauterine adhesions | 3 months after myomectomy | Proportion of enrolled women with intrauterine adhesions identified by office diagnostic hysteroscopy. Intrauterine adhesions were defined according to the European Society of Gynecological Endoscopy (ESGE) criteria. |
Countries
Italy
Contacts
STUDY_CHAIRAndrea Tinelli
Vito Fazzi Hospital
STUDY_CHAIRAntonio Simone Laganà
Università degli Studi dell'Insubria
STUDY_DIRECTORJose Carugno
University of Miami
Outcome results
None listed