Sterility, FemaleNCT03788421
Comparison Between 2 Techniques for Bilateral Salpingectomy
A study testing LIGASURE and Clamping and suturing in people with Sterility, Female, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sterility, Female
- What is being tested?
- LIGASURE and Clamping and suturing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants undergoing elective Cesarean Section and are interested and have signed informed consent regarding bilateral salpingectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section
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.
Read the 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.
- Conditions
- Sterility, Female
- Being tested
- LIGASURE, Clamping and suturing
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIGASUREDevice
Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.
Clamping and suturingProcedure or surgery
Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE. Receives: Device: LIGASURE |
| Control group | Active comparator | Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing. Receives: Procedure: Clamping and suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total salpingectomy time.
Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.
Measured: Up to 1 week from recruitment
Secondary outcomes (8)
Bleeding during salpingectomy
Estimated amount of bleeding in milliliters during the salpingectomy procedure
Measured: 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.
Measured: Up to 4 hours from the beginning of the procedure
Hemoglobin level
Changes in hemoglobin level before and after surgery
Measured: Up to 5 days from surgery
Blood transfusion rate
The rate of blood transfusion post cesarean section
Measured: Up to 5 days from surgery
Postoperative stay
The length of maternal postoperative stay.
Measured: Up to 2 weeks from surgery
Visual analogue score
Pain scoring between 0-10 post-surgery
Measured: Up to 2 weeks from surgery
Wound complications
The rate of wound complications postpartum.
Measured: Up to 2 weeks from surgery
Need for opioids
The rate of opioid treatment postpartum
Measured: Up to 2 weeks from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sterility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaniv Zipori MD, Rambam Health Care Campus
- Investigators
- Yaniv Zipori, MD, Principal investigator, Rambam healthcare campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788421
- Sponsor's protocol ID
- 0427 - 18 - RMB
- Status last verified
- Feb 2022
- First submitted
- 25 Dec 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section
- ClinicalTrials.gov ID
- NCT03788421
- Acronym / sponsor ID
- 0427 - 18 - RMB
- Conditions
- Sterility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: LIGASUREWomen undergoing elective bilateral salpingectomy during cesarean section with LIGASURE. |
| Control group | Active comparator | Procedure: Clamping and suturingWomen undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants undergoing elective Cesarean Section and are interested and have signed informed consent regarding bilateral salpingectomy.
Key exclusion criteria (7 listed)
- Inability to give informed consent.
- Preterm delivery (< 37 weeks' gestation).
- Fetal demise.
- Prenatal diagnosis of fetal or placental abnormalities.
- Previous tubal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIGASUREElectricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis. | Device | Study group |
| Clamping and suturingStep by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy. | Procedure or surgery | Control group |
Primary outcome
Total salpingectomy time.
Time frame: Up to 1 week from recruitment
Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.
8 secondary outcomes
Bleeding during salpingectomy
Time frame: Up to 4 hours from the beginning of the procedure
Bleeding during cesarean section
Time frame: Up to 4 hours from the beginning of the procedure
Hemoglobin level
Time frame: Up to 5 days from surgery
Blood transfusion rate
Time frame: Up to 5 days from surgery
Postoperative stay
Time frame: Up to 2 weeks from surgery
Visual analogue score
Time frame: Up to 2 weeks from surgery
Wound complications
Time frame: Up to 2 weeks from surgery
Need for opioids
Time frame: Up to 2 weeks from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaniv Zipori, MD principal investigator
Rambam healthcare campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIGASURE and Clamping and suturing in people with Sterility, Female, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total salpingectomy time. (time frame: Up to 1 week from recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.