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The study hypothesis is that surgical treatment performed with MiniLap results in reduced postoperative pain in a population of patients undergoing prophylactic laparoscopic adnexal surgery. The primary objectives are to assess differences in operative duration, intraoperative blood loss, and postoperative complications in patients undergoing bilateral laparoscopic adnexectomy performed with standard laparoscopy versus MiniLap. The secondary objectives of this study are to compare postoperative pain and patient satisfaction with aesthetic outcomes.
Patients with BRCA 1/2 mutations undergoing prophylactic surgery will be assigned to either MiniLap or standard laparoscopic treatment based on randomization. Subsequently, the necessary study data will be collected using the hospital's electronic management system and medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Standard laparoscopy | Active Comparator | Bilateral salpingo-oophorectomy performed with standard laparoscopy |
|
| B: MiniLap | Experimental | Bilateral salpingo-oophorectomy performed with MiniLap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral salpingo-oophorectomy - S-LPS | Procedure | In standard laparoscopy (S-LPS), the initial laparoscopic access was performed at the umbilical level using open laparoscopy (Hasson technique). The subsequent accesses were carried out in the right and left iliac fossa. In the S-LPS, these accesses are performed using a 5mm trocars. Finally, a 5mm ancillary trocar was placed in the suprapubic region to use instruments such as bipolar forceps, irrigators, and scissors. The subsequent surgical steps were identical for both techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification) | The primary objectives are to assess differences in: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification) in patients undergoing bilateral laparoscopic adnexectomy performed with standard laparoscopy versus MiniLap. | From enrollment to 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Visual Analog Score) | The secondary objective of this study is to compare postoperative pain (VAS 0-10; higher scores mean worse) | From enrollment to 2 days postoperatively. |
| Cosmetic results (Visual Analog Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Restaino | Contact | +390432559653 | stefano.restaino@asufc.sanita.fvg.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine | Recruiting | Udine | Udine | 33100 | Italy |
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|
| Bilateral salpingo-oophorectomy - PSS | Procedure | In the MiniLap® Percutaneous Surgical System (PSS), the initial laparoscopic access was performed at the umbilical level using open laparoscopy (Hasson technique). The subsequent two accesses were carried out in the right and left iliac fossa. These latter accesses are directly performed using MiniLap® with a 2.4mm incision. Finally, a 5mm ancillary trocar was placed in the suprapubic region to use instruments such as bipolar forceps, irrigators, and scissors. The subsequent surgical steps were identical for both techniques. |
|
The secondary objective of this study is to compare patient satisfaction with aesthetic outcomes using a VAS scale (0-10, with higher scores indicating greater satisfaction).
| From enrollment to 60 days postoperatively. |