Actively Recruiting
MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients
Led by Azienda Sanitaria-Universitaria Integrata di Udine · Updated on 2025-02-18
80
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
- Patients with a germline mutation in the BRCA1/2 gene.
You will not qualify if you...
- Patients who underwent additional surgery during the adnexectomy procedure.
- Patients in whom an intraoperative frozen section is required.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
Udine, Udine, Italy, 33100
Actively Recruiting
Research Team
S
Stefano Restaino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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