Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Total salpingectomy time.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Study group
Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.
Intervention: LIGASURE (Device)
Control group
Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.
Intervention: Clamping and suturing (Procedure)
Outcomes
Primary Outcomes
Total salpingectomy time.
Time Frame: Up to 1 week from recruitment
Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.
Secondary Outcomes
- Bleeding during cesarean section(Up to 4 hours from the beginning of the procedure)
- Need for opioids(Up to 2 weeks from surgery)
- Hemoglobin level(Up to 5 days from surgery)
- Postoperative stay(Up to 2 weeks from surgery)
- Blood transfusion rate(Up to 5 days from surgery)
- Bleeding during salpingectomy(Up to 4 hours from the beginning of the procedure)
- Visual analogue score(Up to 2 weeks from surgery)
- Wound complications(Up to 2 weeks from surgery)
Investigators
Yaniv Zipori MD
Principal Investigator
Rambam Health Care Campus