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

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.

Study Overview

• Status: Completed
• Conditions: Sterilization, Tubal; Salpingectomy
• Intervention / Treatment: Procedure: Surgical sterilization

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Turkey
  • Bartin, Turkey
    • Bartin State Hospital
  • Istanbul, Turkey
    • Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University
  • Istanbul, Turkey
    • Medicalpark Gaziosmanpasa Hospital, Istinye University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who aged over 18 years old and seek for sterilization at the time of cesarean section.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Salpingectomy; Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure	Procedure: Surgical sterilization; Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique
Tubal ligation; Women who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure	Procedure: Surgical sterilization; Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivators for sterilization type	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.	Evaluation at preoperative 32th gestational weeks

Collaborators and Investigators

• Sponsor: Bartin State Hospital
• Investigators: Principal Investigator: Murat Yassa, M.D., specialist

Publications and helpful links

General Publications

• Zamorano AS, Mutch DG. Postpartum salpingectomy: a procedure whose time has come. Am J Obstet Gynecol. 2019 Jan;220(1):8-9. doi: 10.1016/j.ajog.2018.09.041. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2019
• Primary Completion (ACTUAL): December 10, 2019
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: February 3, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (ACTUAL): February 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Opportunistic salpingectomy; Prophylactic salpingectomy; Risk-reducing
• Other Study ID Numbers: EtfalSalp

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No