Pelvic Congestion Syndrome Post Tubal Ligation Versus Salpingectomy Performed During Caesarean Se… (NCT06509425) | Clinical Trial Compass
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Pelvic Congestion Syndrome Post Tubal Ligation Versus Salpingectomy Performed During Caesarean Section
Egypt64 participantsStarted 2024-05-21
Plain-language summary
Permanent tubal sterilization during Caesarean section is a reliable method of contraception. It is done either by bilateral tubal ligation or bilateral salpingectomy according to surgeon's preference.
Studies revealing bilateral salpingectomy has an added benefit of primary prevention of ovarian cancer has encouraged surgeons to perform bilateral salpingectomy rather than tubal ligation as a risk reducing surgery owing to the acceptance of fallopian tubes as the origin of high grade serous ovarian cancer.
Another aspect to take into consideration is the post tubal ligation syndrome as it severely affects the quality of life. Diagnosis is based on clinical picture, imaging, and exclusion of other causes of chronic pelvic pain. Women experience dysmenorrhea, dyspareunia, menstrual irregularities, and pelvic pain. The gold standard is venography; however, the first choice for initial evaluation is duplex ultrasound.
In this study, we assess impact of bilateral salpingectomy versus tubal ligation in terms of pelvic congestion by participant's symptoms and ultrasound findings
Who can participate
Age range
30 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Females undergoing caesarean section and requesting tubal sterilization as a permanent method of contraception.
* 30 years or older
Exclusion Criteria:
* Previous history of tubal surgery (changes in blood flow)
* Previous history of oophorectomy (changes in blood flow)
* Congenital anomalies or malformations in fallopian tubes or ovaries. (affection of normal anatomy of pelvic blood vessels)
* Women diagnosed with pelvic congestion. (Known cause for pelvic congestion other than tubal sterilization)
* High likelihood of lost to follow up.
* Inability to provide good data.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing tubal ligation versus salpingectomy done during a C-section and their link to pelvic congestion syndrome — if I'm already planning a C-section, is this something worth discussing as part of my surgical planning?
2Since this study is specifically measuring symptoms of pelvic congestion syndrome, what symptoms should I watch for after my C-section, and how would the choice between tubal ligation and salpingectomy affect my risk of developing them?
3The trial's recruitment status is listed as unknown — do you know if this study is still actively enrolling patients, and is there a similar study or registry I could participate in if this one isn't available?
4Because this is listed as a 'Phase NA' observational or procedural study, what is already known about whether tubal ligation or salpingectomy carries a higher risk of pelvic congestion syndrome, and should that influence which procedure we choose for me?
5If I do develop pelvic congestion syndrome after either procedure, what treatment options would be available to me, and does participating in this trial affect how my symptoms would be managed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.