Comparison Between 2 Techniques for Bilateral Salpingectomy

Rambam Health Care Campus

Status: Completed

Conditions: Sterility, Female

Treatments: Device: LIGASURE; Procedure: Clamping and suturing

Study type: Interventional

Funder types: Other

Identifiers

NCT03788421

0427 - 18 - RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

51 participants in 2 patient groups

Study group

Active Comparator group

Description:

Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.

Treatment:

Device: LIGASURE

Control group

Active Comparator group

Description:

Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.

Treatment:

Procedure: Clamping and suturing