BRCA MutationNCT06831747
MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients
A study testing Bilateral salpingo-oophorectomy - S-LPS and Bilateral salpingo-oophorectomy - PSS in people with BRCA Mutation, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA Mutation
- What is being tested?
- Bilateral salpingo-oophorectomy - S-LPS and Bilateral salpingo-oophorectomy - PSS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
- Patients with a germline mutation in the BRCA1/2 gene.
Who cannot join
- Patients who underwent additional surgery during the adnexectomy procedure.
- Patients in whom an intraoperative frozen section is required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
Udine, Udine, 33100
Stefano Restaino, +390432559653, stefano.restaino@asufc.sanita.fvg.it
About this study
Official title: MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial
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
- BRCA Mutation
- Being tested
- Bilateral salpingo-oophorectomy - S-LPS, Bilateral salpingo-oophorectomy - PSS
- Keywords
- Laparoscopy, BRCA mutations, Salpingo-Oophorectomy, MiniLap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral salpingo-oophorectomy - S-LPSProcedure or surgery
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.
Bilateral salpingo-oophorectomy - PSSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| A: Standard laparoscopy | Active comparator | Bilateral salpingo-oophorectomy performed with standard laparoscopy Receives: Procedure: Bilateral salpingo-oophorectomy - S-LPS |
| B: MiniLap | Experimental | Bilateral salpingo-oophorectomy performed with MiniLap Receives: Procedure: Bilateral salpingo-oophorectomy - PSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 30 days postoperatively
Secondary outcomes (2)
Pain (Visual Analog Score)
The secondary objective of this study is to compare postoperative pain (VAS 0-10; higher scores mean worse)
Measured: From enrollment to 2 days postoperatively.
Cosmetic results (Visual Analog Score)
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).
Measured: From enrollment to 60 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start8 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Restaino, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831747
- Sponsor's protocol ID
- 0022677
- Status last verified
- Feb 2025
- First submitted
- 19 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06831747
- Acronym / sponsor ID
- 0022677
- Conditions
- BRCA Mutation
- Keywords
- Laparoscopy, BRCA mutations, Salpingo-Oophorectomy, MiniLap
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Standard laparoscopy | Active comparator | Procedure: Bilateral salpingo-oophorectomy - S-LPSBilateral salpingo-oophorectomy performed with standard laparoscopy |
| B: MiniLap | Experimental | Procedure: Bilateral salpingo-oophorectomy - PSSBilateral salpingo-oophorectomy performed with MiniLap |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
- Patients with a germline mutation in the BRCA1/2 gene.
Key exclusion criteria (2 listed)
- Patients who underwent additional surgery during the adnexectomy procedure.
- Patients in whom an intraoperative frozen section is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral salpingo-oophorectomy - S-LPSIn 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. | Procedure or surgery | A: Standard laparoscopy |
| Bilateral salpingo-oophorectomy - PSSIn 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. | Procedure or surgery | B: MiniLap |
Primary outcome
Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification)
Time frame: 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.
2 secondary outcomes
Pain (Visual Analog Score)
Time frame: From enrollment to 2 days postoperatively.
Cosmetic results (Visual Analog Score)
Time frame: From enrollment to 60 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral salpingo-oophorectomy - S-LPS and Bilateral salpingo-oophorectomy - PSS in people with BRCA Mutation, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Restaino (+390432559653, stefano.restaino@asufc.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification) (time frame: From enrollment to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.