Comparison Between 2 Techniques for Bilateral Salpingectomy

Rambam Health Care Campus51 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sterility, Female

Interventions

LIGASUREDEVICE

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

Clamping and suturingPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rambam health care campus

Haifa, Israel

Outcomes

Primary Outcomes

Total salpingectomy time.

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

Time frame: Up to 1 week from recruitment

Secondary Outcomes

Bleeding during salpingectomy

Estimated amount of bleeding in milliliters during the salpingectomy procedure

Time frame: 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.

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

Hemoglobin level

Changes in hemoglobin level before and after surgery

Time frame: Up to 5 days from surgery

Blood transfusion rate

The rate of blood transfusion post cesarean section

Time frame: Up to 5 days from surgery

Postoperative stay

The length of maternal postoperative stay.

Time frame: Up to 2 weeks from surgery

Visual analogue score

Pain scoring between 0-10 post-surgery

Time frame: Up to 2 weeks from surgery

Wound complications

The rate of wound complications postpartum.

Time frame: Up to 2 weeks from surgery

Data from ClinicalTrials.gov

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