Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy
NCT ID: NCT01929148
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
154 participants
INTERVENTIONAL
2013-08-31
2016-12-31
Brief Summary
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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.
Detailed Description
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Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI. For each surgical procedure, moreover, operative time, variation of hemoglobin level, postoperative hospital stay, postoperative return to normal activity and complication rate will be recorded as secondary outcomes.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Laparoscopic myomectomy plus PBS
A Laparoscopic myomectomy plus Prophylactic bilateral salpingectomy will be performed in women which have accomplished their reproductive desire
Prophylactic bilateral salpingectomy
Salpingectomy will be performed by coagulation and section of the tube, beginning from the very distal fimbrial end, carefully preserving the ovarian vascularization, and proceeding toward the uterine cornu
Laparoscopic myomectomy without PBS
A standard laparoscopic myomectomy without any prophylactic salpingectomy will be performed
Laparoscopic myomectomy without PBS
Standard laparoscopic myomectomy without salpingectomy
Interventions
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Prophylactic bilateral salpingectomy
Salpingectomy will be performed by coagulation and section of the tube, beginning from the very distal fimbrial end, carefully preserving the ovarian vascularization, and proceeding toward the uterine cornu
Laparoscopic myomectomy without PBS
Standard laparoscopic myomectomy without salpingectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Accomplished reproductive desire
Exclusion Criteria
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Fulvio Zullo
Full Professor
Principal Investigators
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Fulvio Zullo, Md, PhD
Role: STUDY_DIRECTOR
Magna Graecia University of Catanzaro
Roberta Venturella
Role: PRINCIPAL_INVESTIGATOR
Magna Graecia University of Catanzaro
Locations
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Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, CZ, Italy
Countries
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Facility Contacts
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Fulvio Zullo, MD, PhD
Role: primary
References
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Morelli 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.
Other Identifiers
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PBS_myomectomy
Identifier Type: -
Identifier Source: org_study_id