Clinical trial · Interventional
Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy
Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH) has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative hospital stay, postoperative return to normal activity and complication rate) are related to PBS step in TLH. Although the good statistical reliability of our retrospective data, we want to prospectively confirm our results. Moreover we aim to refine PBS safety demonstration by collecting also 3D ultrasound parameters \[AFC, ovarian volume (OV), Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI)\]. Hormonal and ultrasonographic parameters may possibly be unified into a new diagnostic algorithm (already at an advanced stage of production in UMG Department) able to estimate the ovarian function both in term of reproductive ability that in term of distance from menopause.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Uterine Bleeding, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic myomectomy without PBS | Procedure | — | UNRESOLVED |
| Prophylactic bilateral salpingectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic myomectomy plus PBS
- description
- A Laparoscopic myomectomy plus Prophylactic bilateral salpingectomy will be performed in women which have accomplished their reproductive desire
- interventionNames
- Procedure: Prophylactic bilateral salpingectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic myomectomy without PBS
- description
- A standard laparoscopic myomectomy without any prophylactic salpingectomy will be performed
- interventionNames
- Procedure: Laparoscopic myomectomy without PBS
Primary outcomes (1)
- measure
- Ovarian reserve modification
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Indication to laparoscopic myomectomy * Accomplished reproductive desire Exclusion Criteria: * Age older than 50 years * family history of ovarian cancer, BRCA positive * basal FSH value of \>20 IU/mL and/or E2 levels \>60 pg/mL * presence of menopausal symptoms,irregular (cycle-to-cycle variation over 12 months \>20 days orpresence of any breakthrough bleeding) menstrual cycles, hormonereplacement treatment and/or hormonal contraception for the last 3 months, history of previous uterine or ovarian surgeries, and imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound.
References
Publications (1)
- BACKGROUNDMorelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, D'Alessandro P, Zullo F. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gynecol Oncol. 2013 Jun;129(3):448-51. doi: 10.1016/j.ygyno.2013.03.023. Epub 2013 Apr 2. PMID 23558052