Comparison Between 2 Techniques for Bilateral Salpingectomy

Not Applicable

Completed

• Conditions: Sterility, Female
• Interventions: Procedure: Clamping and suturing; Device: LIGASURE

• Registration Number: NCT03788421
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-27
• Study Start: 2019-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-09-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Clamping and suturing	Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.
Study group	LIGASURE	Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.

Primary Outcome Measures

Name	Time	Method
Total salpingectomy time.	Up to 1 week from recruitment	Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel