Salpingectomy During Cesarean Section (SCS)

• ClinicalTrials.gov Identifier: NCT02880423
• Recruitment Status: Unknown
• First Posted: August 26, 2016
• Last Update Posted: August 26, 2016
• Sponsor: Bnai Zion Medical Center
• Information provided by (Responsible Party): enab.kadour, Bnai Zion Medical Center

Tracking Information

• First Submitted Date: July 29, 2016
• First Posted Date: August 26, 2016
• Last Update Posted Date: August 26, 2016
• Study Start Date: September 2016
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2016)

intra- operative complications [ Time Frame: 5 days ]

operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 25, 2016)

long term complication [ Time Frame: 3 months ]

pain after surgery, signs and symptoms of menopause, reduced ovarian reserve by AMH test

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Salpingectomy During Cesarean Section
• Official Title: Salpingectomy During Cesarean Section, for Risk Reduction of Ovarian Cancer, Compared With Tubal Ligation- Morbidity and Long Term Complications
• 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 .

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• 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

• 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.

Study Arms

• salpingectomy group I
  salpingectomy during cesarean section for sterilization
  Intervention: Procedure: salpingectomy group I
• Active Comparator: tubal ligation group II
  tubal ligation in cesarean section
  Intervention: Procedure: tubal ligation group II

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 25, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2018
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 30 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02880423
• Other Study ID Numbers: 0012-16BNZ
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: enab.kadour, Bnai Zion Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Bnai Zion Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: sagi shlomi, md; helsinki bnai zion

• PRS Account: Bnai Zion Medical Center
• Verification Date: August 2016