SalpingectomyNCT03830502
Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section
An observational study of Salpingectomy and Sterilization, Tubal, run by Bartin State Hospital at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Salpingectomy, Sterilization, Tubal
- What is being tested?
- Surgical sterilization
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 10 Feb 2019to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who aged over 18 years old and seek for sterilization at the time of cesarean section.
Who may be able to join
- Women seeking for surgical sterilization during their cesarean section
- Elective and Category 2 or more planned cesarean sections
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Bartin State Hospital
Bartın
Istanbul Sisli Hamidiye Etfal Training And Research Hospital, Health Sciences University
Istanbul
Medicalpark Gaziosmanpasa Hospital, Istinye University
Istanbul
About this study
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.
Read the 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.
- Conditions
- Salpingectomy, Sterilization, Tubal
- Being tested
- Surgical sterilization
- Keywords
- Prophylactic salpingectomy, Opportunistic salpingectomy, Risk-reducing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical sterilizationProcedure or surgery
Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique
| Study group | Role | What they receive |
|---|---|---|
| Salpingectomy | Women who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure Receives: Procedure: Surgical sterilization | |
| Tubal ligation | Women who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure Receives: Procedure: Surgical sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluation at preoperative 32th gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start10 Feb 2019
- Primary completion10 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SalpingectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartin State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Yassa, Bartin State Hospital
- Investigators
- Murat Yassa, M.D., Principal investigator, Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830502
- Sponsor's protocol ID
- EtfalSalp
- Status last verified
- Apr 2020
- First submitted
- 3 Feb 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30591122
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section
- ClinicalTrials.gov ID
- NCT03830502
- Acronym / sponsor ID
- EtfalSalp
- Conditions
- Salpingectomy, Sterilization, Tubal
- Keywords
- Prophylactic salpingectomy, Opportunistic salpingectomy, Risk-reducing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Bartin State HospitalOther government
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salpingectomy | – | Procedure: Surgical sterilizationWomen who gave consent for opportunistic prophylactic bilateral salpingectomy during cesarean section as a Surgical sterilization procedure |
| Tubal ligation | – | Procedure: Surgical sterilizationWomen who refused salpingectomy and gave consent for tubal ligation during cesarean section as a Surgical sterilization procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who aged over 18 years old and seek for sterilization at the time of cesarean section.
Key inclusion criteria (2 listed)
- Women seeking for surgical sterilization during their cesarean section
- Elective and Category 2 or more planned cesarean sections
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical sterilizationSurgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique | Procedure or surgery | Salpingectomy, Tubal ligation |
Primary outcome
Motivators for sterilization type
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Background: PubMed 30591122Zamorano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Yassa, M.D. principal investigator
Specialist
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salpingectomy and Sterilization, Tubal, run by Bartin State Hospital at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivators for sterilization type (time frame: Evaluation at preoperative 32th gestational weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.