A Retrospective Study for Developing a Nomogram for Predicting Change of Complete Myoma Resection During Hysteroscopic Myomectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Uterine Fibroids
- Sponsor
- Ospedale Policlinico San Martino
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Number of patients with complete resection of myomas
- Last Updated
- 5 years ago
Overview
Brief Summary
The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram.
This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy.
Detailed Description
Overall, 10% of all uterine myomas are submucosal. These myomas spread into the uterine cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding, dysmenorrhea, early miscarriage and they may be a cause of infertility. Hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal myomas, because it is minimally invasive and has the advantage of preserving the integrity of the uterine wall. The characteristics of the myomas (size, number and location) enables the surgeon to choose the surgical approach that will provide the best outcome for the patient, and may predict the chances of a complete hysteroscopic resection of myomas in one procedure.
Investigators
Fabio Barra
Principal Investigator
Ospedale Policlinico San Martino
Eligibility Criteria
Inclusion Criteria
- •patients with ultrasonographic diagnosis of uterine myomas
Exclusion Criteria
- •patients with previous incomplete hysteroscopic myoma resection;
- •patients undergoing additional surgical procedures performed by hysteroscopy (such as, resection of endometrial polyps);
- •patients undergoing associated non-hysteroscopic surgical procedures;
- •patients with severe cardiovascular disease, decompensated diabetes and severe hematologic disorders
Outcomes
Primary Outcomes
Number of patients with complete resection of myomas
Time Frame: At the end of the hysteroscopic procedure