Impact of Salpingectomy on Ovarian Reserve

Not Applicable

Completed

• Conditions: Laparoscopic Salpingectomy
• Interventions: Device: Bipolar electric energy; Device: ultrasound energy

• Registration Number: NCT02284711
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Study Start: 2015-03-09
• Primary Completion: 2020-10-16
• Study Completion: 2020-10-16
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-01
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar	Bipolar electric energy	Coagulation during salpingectomy using conventional bipolar electric energy
Ultrasound	ultrasound energy	Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

Primary Outcome Measures

Name	Time	Method
AMH level	3 months post-surgery

Secondary Outcome Measures

Name	Time	Method
menopausal quality of life score	1 and 3 months post-surgery
index of vascular resistance in the ovarian vessels	1 and 3 months post-surgery
AMH level	1 month post-surgery

Trial Locations

Locations (1)

Hospices Civils de Lyon - HFME; 🇫🇷 Lyon, France