Comparison Between 2 Techniques for Bilateral Salpingectomy

Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Sterility, Female
• Intervention / Treatment: Device: LIGASURE; Procedure: Clamping and suturing

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total salpingectomy time.	Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.	Up to 1 week from recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding during salpingectomy	Estimated amount of bleeding in milliliters during the salpingectomy procedure	Up to 4 hours from the beginning of the procedure
Bleeding during cesarean section	Estimated amount of bleeding in milliliters during the whole cesarean section.	Up to 4 hours from the beginning of the procedure
Hemoglobin level	Changes in hemoglobin level before and after surgery	Up to 5 days from surgery
Blood transfusion rate	The rate of blood transfusion post cesarean section	Up to 5 days from surgery
Postoperative stay	The length of maternal postoperative stay.	Up to 2 weeks from surgery
Visual analogue score	Pain scoring between 0-10 post-surgery	Up to 2 weeks from surgery
Wound complications	The rate of wound complications postpartum.	Up to 2 weeks from surgery
Need for opioids	The rate of opioid treatment postpartum	Up to 2 weeks from surgery

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Yaniv Zipori, MD, Rambam healthcare campus

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (ACTUAL): December 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 0427 - 18 - RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No