Impact of Salpingectomy on Ovarian Reserve

Laparoscopic Salpingectomy Clinical Trial

— SALPOVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284711
• Other study ID #: 69HCL14_0166
• Secondary ID: 2014-A01218-39
• Status: Completed
• Phase: N/A
• Start date: March 9, 2015
• Est. completion date: October 16, 2020

Study information

• Verified date: April 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Salpingectomy

Intervention

Device:
• Bipolar electric energy
Coagulation during salpingectomy using conventional bipolar electric energy
• ultrasound energy
Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - HFME	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMH level		3 months post-surgery
Secondary	AMH level		1 month post-surgery
Secondary	index of vascular resistance in the ovarian vessels		1 and 3 months post-surgery
Secondary	menopausal quality of life score		1 and 3 months post-surgery