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
Not provided
Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.
This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics.
Patients will be randomized 1:1 in two groups:
Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration.
The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Hysterectomy by bipolar coagulation technique | Other | The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the portio, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking, section and ligament of the ligaments uterus-sacral ligaments, and subsequent coagulation by bipolar instrument of the other structures of the uterus and their section, in particular of the uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally. |
|
| Vaginal hysterectomy by traditional technique with reabsorbable stitches | Other | The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the port, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking and suturing with absorbable threads of all the support structures of the uterus, in particular uterus-sacral ligaments, uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal hysterectomy by bipolar vessels sealing | Procedure | The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be coagulated and cut by a bipolar vessel sealing instrument |
| Measure | Description | Time Frame |
|---|---|---|
| Learning curve comparison | The primary objective of the study is to compare the learning curves (in terms of operating time, blood loss, intraoperative complications) for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. The two procedures compared will be the traditional technique performed by applying reabsorbable sutures and the bipolar coagulation technique. | immediate post operative time |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of the two different techniques of vaginal hysterectomy. | Effectiveness will be assessed in terms of short-term outcomes such as: Intraoperative complications post-operative pain inpatient time Post-operative urinary infections vaginal infections, postoperative collected hematomas | 3 days after the surgical procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arianna Casiraghi, MD | Contact | 3482400195 | casiraghi.arianna@hsr.it | |
| Stefano Salvatore, MD | Contact | salvatore.stefano@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Salvatore, MD | San Raffaele Hospital, Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arianna Casiraghi | Milan | 20159 | Italy |
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Patients will be randomized 1:1 in two groups:
Not provided
Not provided
Not provided
Not provided
| vaginal hysterectomy by traditional technique | Procedure | The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads |
|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |