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Trial record 3 of 40 for:    salpingectomy

Impact of Salpingectomy on Ovarian Reserve (SALPOVA)

This study is currently recruiting participants.
Verified October 2016 by Hospices Civils de Lyon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284711
First Posted: November 6, 2014
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose

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.


Condition Intervention
Laparoscopic Salpingectomy Device: Bipolar electric energy Device: ultrasound energy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Salpingectomy on Ovarian Reserve, With Comparison Between Two Coagulation Techniques

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • AMH level [ Time Frame: 3 months post-surgery ]

Secondary Outcome Measures:
  • AMH level [ Time Frame: 1 month post-surgery ]
  • index of vascular resistance in the ovarian vessels [ Time Frame: 1 and 3 months post-surgery ]
  • menopausal quality of life score [ Time Frame: 1 and 3 months post-surgery ]

Estimated Enrollment: 80
Study Start Date: March 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bipolar
Coagulation during salpingectomy using conventional bipolar electric energy
Device: Bipolar electric energy
Coagulation during salpingectomy using conventional bipolar electric energy
Active Comparator: Ultrasound
Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy
Device: ultrasound energy
Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284711


Contacts
Contact: Gery LAMBLIN, Dr 4 72 35 58 71 ext +33 gery.lamblin@chu-lyon.fr

Locations
France
Hospices Civils de Lyon - HFME Recruiting
Lyon, France, 69003
Contact: Gery LAMBLIN         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02284711     History of Changes
Other Study ID Numbers: 69HCL14_0166
First Submitted: November 4, 2014
First Posted: November 6, 2014
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Hospices Civils de Lyon:
salpingectomy, ovarian reserve, coagulation technique