Salpingectomy During Cesarean Section

NCT ID: NCT02880423

Last Updated: 2016-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-07-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

salpingectomy group I

salpingectomy during cesarean section for sterilization

Group Type: OTHER

salpingectomy group I

Intervention Type: PROCEDURE

women who agreed to participate in the study and assigned randomly to this group will have salpingectomy during cesarean section for sterilization.

tubal ligation group II

tubal ligation in cesarean section

Group Type: ACTIVE_COMPARATOR

tubal ligation group II

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

enab.kadour

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sagi shlomi, md

Role: STUDY_CHAIR

helsinki bnai zion

Locations

ISRAEL

Haifa, Israel, Israel

Countries

Israel

Central Contacts

einav kadour, MD

Role: CONTACT

einavkadour@gmail.com

sagi shlomi, MD

Role: CONTACT

shlomi.dagi@b-zion.org.il

Facility Contacts

Einav Kadour, MD

Role: primary

Other Identifiers

0012-16BNZ

Identifier Type: -

Identifier Source: org_study_id