Comparison Between 2 Techniques for Bilateral Salpingectomy

NCT ID: NCT03788421

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-09-01

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.

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.

Conditions

Sterility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.

Group Type: ACTIVE_COMPARATOR

LIGASURE

Intervention Type: DEVICE

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

Control group

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

Group Type: ACTIVE_COMPARATOR

Clamping and suturing

Intervention Type: PROCEDURE

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

Interventions

LIGASURE

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

Intervention Type: DEVICE

Clamping and suturing

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Yaniv Zipori MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaniv Zipori, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam healthcare campus

Locations

Rambam health care campus

Haifa, , Israel

Countries

Israel

Other Identifiers

0427 - 18 - RMB

Identifier Type: -

Identifier Source: org_study_id