Clinical trial · Interventional
Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy
The Effect in Term of Ovarian Reserve Modification of Adding Prophylactic Bilateral Salpingectomy (PBS) to TLH for Preventing Ovarian Cancer
NCT02086344CI-TRIAL-00024842unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this RCT of study is to compare the standard TLH with adnexal preservation with TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical outcomes
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomyosis | — | UNRESOLVED | — |
| Pelvic Pain | — | UNRESOLVED | — |
| Pelvic Prolapse | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PBS | Procedure | — | UNRESOLVED |
| TLH _adnexal preservation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TLH_plus_PBS
- description
- TLH plus PBS
- interventionNames
- Procedure: PBS
- type
- ACTIVE_COMPARATOR
- label
- TLH _adnexal preservation
- description
- Standard TLH without PBS
- interventionNames
- Procedure: TLH _adnexal preservation
Primary outcomes (1)
- measure
- Ovarian reserve modification
- timeFrame
- Three months after laparoscopy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Indication to laparoscopic hysterectomy * Accomplished reproductive desire Exclusion Criteria: * Patients with a family history of ovarian cancer and with a known mutation of the BRCA1/2 genes * Patients with a current or a past history of cancer * Patients who don't consent to the prophylactic salpingectomy * Previous adnexal surgery * PCOS * Estrogen-progestin therapy in the 2 months prior to the enrollment * Acute or chronic pelvic inflammatory disorders * Malignant gynecological neoplasms * Prior chemotherapy or radiotherapy * Autoimmune diseases, chronic, metabolic, endocrine and systemic disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease * Hypogonadotropic hypogonadism * Taking medications that can cause menstrual irregularities * Other clinical conditions
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