Impact of Salpingectomy on Ovarian Reserve

Study Overview
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Brief Summary
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Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The principal objective of the present study is to assess the impact of salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve results between two coagulation techniques used in salpingectomy: bipolar electric energy versus ultrasound. The study design is single-center, prospective, before-and-after, with open randomization between two groups defined by coagulation technique.

Official Title
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Impact of Salpingectomy on Ovarian Reserve, With Comparison Between Two Coagulation Techniques

Conditions
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Laparoscopic Salpingectomy

Intervention / Treatment
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* Device: Bipolar electric energy
* Device: ultrasound energy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects aged 18 Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication Exclusion Criteria: Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc. Pregnancy, ongoing or planned during the study period History of bilateral salpingectomy Salpingectomy associated with pelvic cancer Oral hormonal contraception during the study period Menopause Inability to understand information provided Not covered by a national health insurance scheme, prisoner or under administrative supervision.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bipolar<br>Coagulation during salpingectomy using conventional bipolar electric energy | Device: Bipolar electric energy<br>* Coagulation during salpingectomy using conventional bipolar electric energy<br>|
| Active Comparator: Ultrasound<br>Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy | Device: ultrasound energy<br>* Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMH level |  | 3 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMH level |  | 1 month post-surgery | 
| index of vascular resistance in the ovarian vessels |  | 1 and 3 months post-surgery | 
| menopausal quality of life score |  | 1 and 3 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salpingectomy, ovarian reserve, coagulation technique