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Completed

NCT Number: NCT03788421

Comparison Between 2 Techniques for Bilateral Salpingectomy

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.

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Key information

Conditions

Sterility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to give informed consent.
  • Preterm delivery (< 37 weeks' gestation).
  • Fetal demise.
  • Prenatal diagnosis of fetal or placental abnormalities.
  • Previous tubal surgery.
  • The use of anticoagulants.
  • Associated immunosuppressive conditions.

Treatment and study plan

LIGASURE

Device

Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.

Clamping and suturing

Procedure

Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.

Primary outcomes

  1. Total salpingectomy time.

    Time frame: Up to 1 week from recruitment

    Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.

Secondary outcomes

  1. Bleeding during salpingectomy

    Time frame: Up to 4 hours from the beginning of the procedure

    Estimated amount of bleeding in milliliters during the salpingectomy procedure

  2. Bleeding during cesarean section

    Time frame: Up to 4 hours from the beginning of the procedure

    Estimated amount of bleeding in milliliters during the whole cesarean section.

  3. Hemoglobin level

    Time frame: Up to 5 days from surgery

    Changes in hemoglobin level before and after surgery

  4. Blood transfusion rate

    Time frame: Up to 5 days from surgery

    The rate of blood transfusion post cesarean section

  5. Postoperative stay

    Time frame: Up to 2 weeks from surgery

    The length of maternal postoperative stay.

  6. Visual analogue score

    Time frame: Up to 2 weeks from surgery

    Pain scoring between 0-10 post-surgery

  7. Wound complications

    Time frame: Up to 2 weeks from surgery

    The rate of wound complications postpartum.

  8. Need for opioids

    Time frame: Up to 2 weeks from surgery

    The rate of opioid treatment postpartum

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 27, 2018
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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