Sterility, Female
Conditions
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.
Interventions
DEVICELIGASURE
Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.
PROCEDUREClamping and suturing
Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total salpingectomy time. | Up to 1 week from recruitment | Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Hemoglobin level | Up to 5 days from surgery | Changes in hemoglobin level before and after surgery |
| 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. |
| Need for opioids | Up to 2 weeks from surgery | The rate of opioid treatment postpartum |
| Postoperative stay | Up to 2 weeks from surgery | The length of maternal postoperative stay. |
Countries
Israel
Outcome results
None listed