Salpingectomy During Cesarean Section (SCS)

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 .

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Procedure: salpingectomy group I; Procedure: tubal ligation group II

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
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31048
    • ISRAEL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intra- operative complications	operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long term complication	pain after surgery, signs and symptoms of menopause, reduced ovarian reserve by AMH test	3 months

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Study Chair: sagi shlomi, md, helsinki bnai zion

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Estimate): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: cesarean section; morbidity; salpingectomy; tubal ligation
• Other Study ID Numbers: 0012-16BNZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO