An interventional study of LIGASURE and Clamping and suturing in Sterility, Female, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 51 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.
Device: LIGASURE
Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.
Procedure: Clamping and suturing
Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.
Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.
Total salpingectomy time.
Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.
Time frame: Up to 1 week from recruitment
Bleeding during salpingectomy
Estimated amount of bleeding in milliliters during the salpingectomy procedure
Time frame: 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.
Time frame: Up to 4 hours from the beginning of the procedure
Hemoglobin level
Changes in hemoglobin level before and after surgery
Time frame: Up to 5 days from surgery
Blood transfusion rate
The rate of blood transfusion post cesarean section
Time frame: Up to 5 days from surgery
Postoperative stay
The length of maternal postoperative stay.
Time frame: Up to 2 weeks from surgery
Visual analogue score
Pain scoring between 0-10 post-surgery
Time frame: Up to 2 weeks from surgery
Wound complications
The rate of wound complications postpartum.
Time frame: Up to 2 weeks from surgery
Need for opioids
The rate of opioid treatment postpartum
Time frame: Up to 2 weeks from surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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