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Comparison Between 2 Techniques for Bilateral Salpingectomy

Primary Purpose

Sterility, Female

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
LIGASURE
Clamping and suturing
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sterility, Female

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam health care campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study group

Control group

Arm Description

Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.

Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.

Outcomes

Primary Outcome Measures

Total salpingectomy time.
Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.

Secondary Outcome Measures

Bleeding during salpingectomy
Estimated amount of bleeding in milliliters during the salpingectomy procedure
Bleeding during cesarean section
Estimated amount of bleeding in milliliters during the whole cesarean section.
Hemoglobin level
Changes in hemoglobin level before and after surgery
Blood transfusion rate
The rate of blood transfusion post cesarean section
Postoperative stay
The length of maternal postoperative stay.
Visual analogue score
Pain scoring between 0-10 post-surgery
Wound complications
The rate of wound complications postpartum.
Need for opioids
The rate of opioid treatment postpartum

Full Information

First Posted
December 25, 2018
Last Updated
February 22, 2022
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03788421
Brief Title
Comparison Between 2 Techniques for Bilateral Salpingectomy
Official Title
Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.
Intervention Type
Device
Intervention Name(s)
LIGASURE
Intervention Description
Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.
Intervention Type
Procedure
Intervention Name(s)
Clamping and suturing
Intervention Description
Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.
Primary Outcome Measure Information:
Title
Total salpingectomy time.
Description
Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.
Time Frame
Up to 1 week from recruitment
Secondary Outcome Measure Information:
Title
Bleeding during salpingectomy
Description
Estimated amount of bleeding in milliliters during the salpingectomy procedure
Time Frame
Up to 4 hours from the beginning of the procedure
Title
Bleeding during cesarean section
Description
Estimated amount of bleeding in milliliters during the whole cesarean section.
Time Frame
Up to 4 hours from the beginning of the procedure
Title
Hemoglobin level
Description
Changes in hemoglobin level before and after surgery
Time Frame
Up to 5 days from surgery
Title
Blood transfusion rate
Description
The rate of blood transfusion post cesarean section
Time Frame
Up to 5 days from surgery
Title
Postoperative stay
Description
The length of maternal postoperative stay.
Time Frame
Up to 2 weeks from surgery
Title
Visual analogue score
Description
Pain scoring between 0-10 post-surgery
Time Frame
Up to 2 weeks from surgery
Title
Wound complications
Description
The rate of wound complications postpartum.
Time Frame
Up to 2 weeks from surgery
Title
Need for opioids
Description
The rate of opioid treatment postpartum
Time Frame
Up to 2 weeks from surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaniv Zipori, MD
Organizational Affiliation
Rambam healthcare campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Between 2 Techniques for Bilateral Salpingectomy

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