Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section

Completed

• Conditions: Salpingectomy; Sterilization, Tubal
• Interventions: Procedure: Surgical sterilization

• Registration Number: NCT03830502
• Lead Sponsor: Bartin State Hospital

Brief Summary

Prophylactic (Opportunistic) salpingectomy is a cost-effective strategy recommended for reducing the risk of ovarian cancer at the time of gynecologic surgery in women who have completed childbearing. Similar evidence for cesarean section is growing. However, salpingectomy refers to the surgical removal of a female reproductive organ. Some women may have hesitations about salpingectomy with regard to religious concerns, reduced self-image, tubal reanastomosis or lack of knowledge.

The investigators aimed to explore the underlying factors that motivate women for either decisions.

Detailed Description

Prophylactic and opportunistic bilateral salpingectomy is an increasing trend among surgeons and also proven as an effective risk-reducing method for ovarian cancer.

The investigators have experienced denials among women who were seeking tubal ligation as a sterilization procedure during cesarean section after a comprehensive counseling for prophylactic salpingectomy. Therefore, the investigators aimed to assess the driving factors of decision making for prophylactic salpingectomy or tubal ligation. It is planned to preoperatively have a non-validated questionnaire for the women after a detailed briefing.

Study Timeline

• Study First Submitted: 2019-02-03
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-02-10
• Primary Completion: 2019-12-10
• Study Completion: 2020-02-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

• Women seeking for surgical sterilization during their cesarean section
• Elective and Category 2 or more planned cesarean sections

Exclusion Criteria

• Clinical conditions that lead to planned cesarean hysterectomy such as placenta percreata
• History of ovarian cancer, previous chemotherapy or radiation
• Women who previously underwent sterilization

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Salpingectomy	Surgical sterilization	Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure
Tubal ligation	Surgical sterilization	Women who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure

Primary Outcome Measures

Name	Time	Method
Motivators for sterilization type	Evaluation at preoperative 32th gestational weeks	A non-validated data collection tool with open-ended questions assessing the factors behind the decision of salpingectomy or tubal ligation. Data collection tool questions why patients choosed or refused salpingectomy in detail. It is not a scale and does not have a range.

Trial Locations

Locations (3)

Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University; 🇹🇷 Istanbul, Turkey

Bartin State Hospital; 🇹🇷 Bartin, Turkey

Medicalpark Gaziosmanpasa Hospital, Istinye University; 🇹🇷 Istanbul, Turkey