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Salpingectomy During Cesarean Section (SCS)

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ClinicalTrials.gov Identifier: NCT02880423
Recruitment Status : Unknown
Verified August 2016 by enab.kadour, Bnai Zion Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
enab.kadour, Bnai Zion Medical Center

Study Description
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Brief 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 sterilization- salpingectomy during cesarean section .

Condition or disease Intervention/treatment Phase
Healthy Procedure: tubal ligation group II Procedure: salpingectomy group I Not Applicable

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:

  1. The duration of the operation,
  2. The rates of bleeding during the operation as estimated by the surgeon,
  3. hemoglobin before and after the surgery,
  4. Rates of giving blood or after surgery
  5. The technical difficulty in performing tubal resection according to surgeon assessment
  6. The need for further surgical intervention

A secondary objective of the study is evaluating the long-term complications:

  1. Assessment of pain intensity at three months after surgery
  2. Evaluation of menopausal symptoms, three months after surgery
  3. Test ovarian sonar and Doppler three months after surgery
  4. Testing the value of AMH three months after surgery
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salpingectomy During Cesarean Section, for Risk Reduction of Ovarian Cancer, Compared With Tubal Ligation- Morbidity and Long Term Complications
Study Start Date : September 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

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Arms and Interventions
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Arm Intervention/treatment
salpingectomy group I
salpingectomy during cesarean section for sterilization
 Procedure: salpingectomy group I
women who agreed to participate in the study and assigned randomly to this group will have salpingectomy during cesarean section for sterilization.
Active Comparator: tubal ligation group II
tubal ligation in cesarean section
 Procedure: tubal ligation group II

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


Outcome Measures
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Primary Outcome Measures :
  1. intra- operative complications [ Time Frame: 5 days ]
    operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS


Secondary Outcome Measures :
  1. long term complication [ Time Frame: 3 months ]
    pain after surgery, signs and symptoms of menopause, reduced ovarian reserve by AMH test


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • women aged less then 30 years
  • women who disagree to participate in the research
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880423


Contacts
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Contact: einav kadour, MD einavkadour@gmail.com
Contact: sagi shlomi, MD shlomi.dagi@b-zion.org.il

Locations
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Israel
ISRAEL
Haifa, Israel, 31048
Contact: Einav Kadour, MD         
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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Study Chair: sagi shlomi, md helsinki bnai zion
More Information
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Responsible Party: enab.kadour, MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT02880423    
Other Study ID Numbers: 0012-16BNZ
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by enab.kadour, Bnai Zion Medical Center:
salpingectomy
cesarean section
tubal ligation
morbidity