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

Sponsor

Bartin State Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03830502

Collaborator

(none)

Enrollment

Locations

11.7

Actual Duration (Months)

19.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Salpingectomy Sterilization, Tubal	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 Design

Study Type:

Observational

Actual Enrollment :

58 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 10, 2019

Actual Primary Completion Date :

Dec 10, 2019

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country
1	Bartin State Hospital	Bartin	Turkey
2	Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University	Istanbul	Turkey
3	Medicalpark Gaziosmanpasa Hospital, Istinye University	Istanbul	Turkey

Sponsors and Collaborators

Bartin State Hospital

Investigators

Principal Investigator: Murat Yassa, M.D., Specialist

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Murat Yassa, Principal Investigator, Bartin State Hospital

ClinicalTrials.gov Identifier:

NCT03830502

Other Study ID Numbers:

EtfalSalp

First Posted:

Feb 5, 2019

Last Update Posted:

Apr 30, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Murat Yassa, Principal Investigator, Bartin State Hospital

Prophylactic salpingectomy

Opportunistic salpingectomy

Risk-reducing

Study Results

No Results Posted as of Apr 30, 2020