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

NCT ID: NCT03830502

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-10

Study Completion Date

2020-02-01

Brief Summary

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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

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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.

Conditions

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Salpingectomy Sterilization, Tubal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Salpingectomy

Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure

Surgical sterilization

Intervention Type PROCEDURE

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

Surgical sterilization

Intervention Type PROCEDURE

Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique

Interventions

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Surgical sterilization

Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bartin State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Murat Yassa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murat Yassa, M.D.

Role: PRINCIPAL_INVESTIGATOR

Specialist

Locations

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Bartin State Hospital

Bartın, , Turkey (Türkiye)

Site Status

Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University

Istanbul, , Turkey (Türkiye)

Site Status

Medicalpark Gaziosmanpasa Hospital, Istinye University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30591122 (View on PubMed)

Other Identifiers

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EtfalSalp

Identifier Type: -

Identifier Source: org_study_id

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