HealthySCSNCT02880423
Salpingectomy During Cesarean Section
A study testing tubal ligation group II and salpingectomy group I in people with Healthy, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Based on the accumulated literature, salpingectomy may significantly reduce the risk for ovarian cancer. If investigators can prove that there is no increase in surgical complications and morbidity during salpingectomy in CS, compared to tubal ligation, investigators can recommend for women who are interested in… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tubal ligation group II and salpingectomy group I
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Jul 2018
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women planned for cesarean section , according to medical or obstetric indication , and seek sterilization
- Women aged 30 and older
- Women who are capable to understand , read and sign an informed consent form
Who cannot join
- women aged less then 30 years
- women who disagree to participate in the research
Trial locations and contacts
1 site in 1 country.
einav kadour, MD contact
sagi shlomi, MD contact
About this study
Official title: Salpingectomy During Cesarean Section, for Risk Reduction of Ovarian Cancer, Compared With Tubal Ligation- Morbidity and Long Term Complications
Based on the accumulated literature, salpingectomy may significantly reduce the risk for ovarian cancer. If investigators can prove that there is no increase in surgical complications and morbidity during salpingectomy in CS, compared to tubal ligation, investigators can recommend for women who are interested in sterilization- salpingectomy during cesarean section .
Read the detailed description
Until recently, ovarian resection was considered the only option to prevent ovarian cancer. Recently new evidence showing that the fallopian tube itself may be the source of certain types of ovarian cancer. So salpingectomy, may offer some protection. However, the extent of this protection has not been determined. Therefore, and based on the foregoing, the investigators think there is an advantage in removal of fallopian tubes rather than tubal ligation Cesarean sections. Given the lack of evidence in the literature about the complications of this procedure, currently the investigators organize a study examines the rate of complications of salpingectomy compared to tubal ligation during cesarean section.
Therefore, the main objective of the study is to assess the incidence of intra-operative complications during cesarean section.
The effect of the procedure will be examined on the following indicators:
- The duration of the operation,
- The rates of bleeding during the operation as estimated by the surgeon,
- hemoglobin before and after the surgery,
- Rates of giving blood or after surgery
- The technical difficulty in performing tubal resection according to surgeon assessment
- The need for further surgical intervention
A secondary objective of the study is evaluating the long-term complications:
- Assessment of pain intensity at three months after surgery
- Evaluation of menopausal symptoms, three months after surgery
- Test ovarian sonar and Doppler three months after surgery
- Testing the value of AMH three months after surgery
- Conditions
- Healthy
- Being tested
- tubal ligation group II, salpingectomy group I
- Keywords
- salpingectomy, cesarean section, tubal ligation, morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tubal ligation group IIProcedure or surgery
Every woman , who is eligible to enter the study in terms of the above criteria , will receive a detailed explanation of the study and will review the consent form , and then be asked whether she agrees to participate in . If so , the participant will stamped on the informed consent form .
The control group will be women who undergo tubal ligation method BTL during cesarean section . All women will be invited to follow up about three months after surgery. The women will answer questionnaire to quantify the symptoms of menopause by NAMS , blood test for AMH and sonar and Doppler examination of both the ovaries
salpingectomy group IProcedure or surgery
women who agreed to participate in the study and assigned randomly to this group will have salpingectomy during cesarean section for sterilization.
| Study group | Role | What they receive |
|---|---|---|
| salpingectomy group I | Other | salpingectomy during cesarean section for sterilization Receives: Procedure: salpingectomy group I |
| tubal ligation group II | Active comparator | tubal ligation in cesarean section Receives: Procedure: tubal ligation group II |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra- operative complications
operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS
Measured: 5 days
Secondary outcomes (1)
long term complication
pain after surgery, signs and symptoms of menopause, reduced ovarian reserve by AMH test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, enab.kadour, Bnai Zion Medical Center
- Investigators
- sagi shlomi, md, Study chair, helsinki bnai zion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880423
- Sponsor's protocol ID
- 0012-16BNZ
- Acronym
- SCS
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salpingectomy During Cesarean Section, for Risk Reduction of Ovarian Cancer, Compared With Tubal Ligation- Morbidity and Long Term Complications
- ClinicalTrials.gov ID
- NCT02880423
- Acronym / sponsor ID
- SCS / 0012-16BNZ
- Conditions
- Healthy
- Keywords
- salpingectomy, cesarean section, tubal ligation, morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Sep 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Based on the accumulated literature, salpingectomy may significantly reduce the risk for ovarian cancer. If investigators can prove that there is no increase in surgical complications and morbidity during salpingectomy in CS, compared to tubal ligation, investigators can recommend for women who are interested in sterilization- salpingectomy during cesarean section .
Detailed description
Until recently, ovarian resection was considered the only option to prevent ovarian cancer. Recently new evidence showing that the fallopian tube itself may be the source of certain types of ovarian cancer. So salpingectomy, may offer some protection. However, the extent of this protection has not been determined. Therefore, and based on the foregoing, the investigators think there is an advantage in removal of fallopian tubes rather than tubal ligation Cesarean sections. Given the lack of evidence in the literature about the complications of this procedure, currently the investigators organize a study examines the rate of complications of salpingectomy compared to tubal ligation during cesarean section.
Therefore, the main objective of the study is to assess the incidence of intra-operative complications during cesarean section.
The effect of the procedure will be examined on the following indicators:
- The duration of the operation,
- The rates of bleeding during the operation as estimated by the surgeon,
- hemoglobin before and after the surgery,
- Rates of giving blood or after surgery
- The technical difficulty in performing tubal resection according to surgeon assessment
- The need for further surgical intervention
A secondary objective of the study is evaluating the long-term complications:
- Assessment of pain intensity at three months after surgery
- Evaluation of menopausal symptoms, three months after surgery
- Test ovarian sonar and Doppler three months after surgery
- Testing the value of AMH three months after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| salpingectomy group I | Other | Procedure: salpingectomy group Isalpingectomy during cesarean section for sterilization |
| tubal ligation group II | Active comparator | Procedure: tubal ligation group IItubal ligation in cesarean section |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women planned for cesarean section , according to medical or obstetric indication , and seek sterilization
- Women aged 30 and older
- Women who are capable to understand , read and sign an informed consent form
Key exclusion criteria (2 listed)
- women aged less then 30 years
- women who disagree to participate in the research
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 |
|---|---|---|
| tubal ligation group IIEvery woman , who is eligible to enter the study in terms of the above criteria , will receive a detailed explanation of the study and will review the consent form , and then be asked whether she agrees to participate in . If so , the participant will stamped on the informed consent form . The control group will be women who undergo tubal ligation method BTL during cesarean section . All women will be invited to follow up about three months after surgery. The women will answer questionnaire to quantify the symptoms of menopause by NAMS , blood test for AMH and sonar and Doppler examination of both the ovaries | Procedure or surgery | tubal ligation group II |
| salpingectomy group Iwomen who agreed to participate in the study and assigned randomly to this group will have salpingectomy during cesarean section for sterilization. | Procedure or surgery | salpingectomy group I |
Primary outcome
intra- operative complications
Time frame: 5 days
operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS
1 secondary outcome
long term complication
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- 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.
einav kadour, MD contact
sagi shlomi, MD contact
sagi shlomi, md study chair
helsinki bnai zion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tubal ligation group II and salpingectomy group I in people with Healthy, run by Bnai Zion Medical Center 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact einav kadour, MD (einavkadour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra- operative complications (time frame: 5 days). 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 26 Aug 2016.