Comparison Between 2 Techniques for Bilateral Salpingectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section

Conditions
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Sterility, Female

Intervention / Treatment
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* Device: LIGASURE
* Procedure: Clamping and suturing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE. | Device: LIGASURE<br>* Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.<br>|
| Active Comparator: Control group<br>Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing. | Procedure: Clamping and suturing<br>* Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total salpingectomy time. | Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure. | Up to 1 week from recruitment | 

Secondary Outcome Measures

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