Laparoscopic Salpingectomy
Conditions
Keywords
salpingectomy, ovarian reserve, coagulation technique
Brief summary
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.
Interventions
DEVICEBipolar electric energy
Coagulation during salpingectomy using conventional bipolar electric energy
DEVICEultrasound energy
Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AMH level | 3 months post-surgery |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed