Comparison Between 2 Techniques for Bilateral Salpingectomy

Sterility, Female Clinical Trial

Official title:

Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788421
• Other study ID #: 0427 - 18 - RMB
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Sterility, Female

Intervention

Device:
• LIGASURE
Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.

Procedure:
• Clamping and suturing
Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total salpingectomy time.	Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.	Up to 1 week from recruitment
Secondary	Bleeding during salpingectomy	Estimated amount of bleeding in milliliters during the salpingectomy procedure	Up to 4 hours from the beginning of the procedure
Secondary	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
Secondary	Hemoglobin level	Changes in hemoglobin level before and after surgery	Up to 5 days from surgery
Secondary	Blood transfusion rate	The rate of blood transfusion post cesarean section	Up to 5 days from surgery
Secondary	Postoperative stay	The length of maternal postoperative stay.	Up to 2 weeks from surgery
Secondary	Visual analogue score	Pain scoring between 0-10 post-surgery	Up to 2 weeks from surgery
Secondary	Wound complications	The rate of wound complications postpartum.	Up to 2 weeks from surgery
Secondary	Need for opioids	The rate of opioid treatment postpartum	Up to 2 weeks from surgery