NCT06831747 MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients
| NCT ID | NCT06831747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Sanitaria-Universitaria Integrata di Udine |
| Condition | BRCA Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-01-08 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06831747 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying BRCA Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06831747 currently recruiting?
Yes, NCT06831747 is actively recruiting participants. Contact the research team at stefano.restaino@asufc.sanita.fvg.it for enrollment information.
Where is the NCT06831747 trial being conducted?
This trial is being conducted at Udine, Italy.
Who is sponsoring the NCT06831747 clinical trial?
NCT06831747 is sponsored by Azienda Sanitaria-Universitaria Integrata di Udine. The trial plans to enroll 80 participants.