BRCA Mutation
Conditions
Keywords
Laparoscopy, BRCA mutations, Salpingo-Oophorectomy, MiniLap
Brief summary
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.
Interventions
PROCEDUREBilateral salpingo-oophorectomy - S-LPS
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.
PROCEDUREBilateral salpingo-oophorectomy - PSS
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.
Sponsors
Azienda Sanitaria-Universitaria Integrata di Udine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery. * Patients with a germline mutation in the BRCA1/2 gene.
Exclusion criteria
* Patients who underwent additional surgery during the adnexectomy procedure. * Patients in whom an intraoperative frozen section is required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification) | From enrollment to 30 days postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain (Visual Analog Score) | From enrollment to 2 days postoperatively. | The secondary objective of this study is to compare postoperative pain (VAS 0-10; higher scores mean worse) |
| Cosmetic results (Visual Analog Score) | From enrollment to 60 days postoperatively. | 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). |
Countries
Italy
Contacts
Primary ContactStefano Restaino
Outcome results
None listed