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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE. |
|
| Control group | Active Comparator | Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIGASURE | Device | Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Yaniv Zipori, MD | Rambam healthcare campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003250 | Constriction |
| D013537 | Sutures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Clamping and suturing | Procedure | Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy. |
|
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 |
| D000091662 | Genital Diseases |
| D007246 | Infertility |