Salpingectomy During Cesarean Section

Healthy Clinical Trial

— SCS  

Official title:

Salpingectomy During Cesarean Section, for Risk Reduction of Ovarian Cancer, Compared With Tubal Ligation- Morbidity and Long Term Complications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02880423
• Other study ID #: 0012-16BNZ
• Status: Not yet recruiting
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 25, 2016
• Start date: September 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2016
• Source: Bnai Zion Medical Center
• Contact: einav kadour, MD
• Email: einavkadour[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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 sterilization- salpingectomy during cesarean section .

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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
• 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.

Locations

Country	Name	City	State
Israel	ISRAEL	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra- operative complications	operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS	5 days	Yes
Secondary	long term complication	pain after surgery, signs and symptoms of menopause, reduced ovarian reserve by AMH test	3 months	Yes