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Comparison Between 2 Techniques for Bilateral Salpingectomy

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ClinicalTrials.gov Identifier: NCT03788421
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yaniv Zipori MD, Rambam Health Care Campus

Brief Summary:

A comparison between 2 techniques for bilateral salpingectomy during cesarean section.

Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.


Condition or disease Intervention/treatment Phase
Sterility, Female Device: LIGASURE Procedure: Clamping and suturing Not Applicable

Detailed Description:

Ovarian cancer is the most lethal gynecologic malignancy. Major contributors to this high mortality are the lack of effective screening strategies, diagnosis at advanced stage of presentation as well as the high risk of recurrence. In the last years the Gynecologic Associations worldwide have recommended that total salpingectomy be considered for potential ovarian cancer risk reduction in benign gynecologic surgeries after completion of childbearing.

However, the data are limit regarding the Preferred surgical technique during cesarean section.

In this randomized controled trial the investigators will compare between various techniques for bilateral salpingectomy during cesarean section.

Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Study group
Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.
Device: LIGASURE
Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.

Active Comparator: Control group
Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.
Procedure: Clamping and suturing
Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.




Primary Outcome Measures :
  1. Surgical time. [ Time Frame: Up to 3 months from recruitment ]
    Time in minutes from beginning of procedure until end of the procedure


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: Up to 1 hour from the beginning of the procedure ]
    Amount of bleeding in milliliters during the procedure

  2. Hemoglobin level [ Time Frame: Up to 2 days from surgery ]
    Changes in hemoglobin level before and after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants undergoing elective Cesarean Section and are interested and have signed informed consent regarding bilateral salpingectomy.

Exclusion Criteria:

  • Pelvic adhesions.
  • Participants with suspicious pelvic findings.

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): NCT03788421


Contacts
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Contact: Yaniv Zipori, MD 0587966963 Y_ZIPORI@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Yaniv Zipori, MD Rambam healthcare campus

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Responsible Party: Yaniv Zipori MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03788421     History of Changes
Other Study ID Numbers: 0427 - 18 - RMB
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female