Efficacy of Transvaginal Ultrasound-guided Aspiration for Treatment of Tubo-ovarian Abscess Compa… (NCT03819309) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Transvaginal Ultrasound-guided Aspiration for Treatment of Tubo-ovarian Abscess Compared With Laparoscopy
France208 participantsStarted 2019-04-30
Plain-language summary
"Tubo-ovarian abscess (TOA) include pyosalpinx, ovarian abscess, tubo-ovarian abscess and Douglas abscess. The only randomized study evaluating TOA treatment reported a higher cure rate (90 versus 65%) when antibiotic therapy is associated with abscess evacuation.
TOA evacuation can be performed by surgery or by drainage. No studies have compared success rates between those two methods.
Concerning surgery, current practices recommend performing laparoscopy which allows a shorter hospital stay, a lower complication rate and high success rates.
The majority of published studies reporting radiological drainage concern ultrasound-guided transvaginal drainage. The reported success rates range from 77 to 100%. The PACTOL trial is a randomized, prospective, controlled, open, parallel, non-inferiority, multicenter trial comparing the efficacy of transvaginal drainage versus laparoscopy in both arms with antibiotic therapy in the treatment of TOA.
Who can participate
Age range
18 Years – 50 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 :
* Major patient aged ≤ 50 at the time of inclusion
* Patient hospitalized for TOA diagnosis defined by:
* a high genital infection (major criteria of recommendations for the clinical practice of CNGOF): spontaneous pelvic pain and induced adnexal pain and / or uterine mobilization pain;
* Visible ultrasound collection in the form of a latero-uterine mass measuring at least 3 cm detailed in the recommendations of the CNGOF:
* tubal wall thickening\> 5 mm
* OR sign of the gear wheel (thickened tubal fringes giving an incomplete septa appearance)
* OR Heterogeneous lateral mass + / - compartmentalized with fine echoes
* Biological inflammatory syndrome (defined by CRP\> 20 or white blood cell\> 10,000 / mm3)
* Uncomplicated: good hemodynamic tolerance, not broken
Exclusion criteria :
* Suspected malignant tumor or Borderline
* Complicated abscess: abscess rupture, generalized peritonitis, septic shock
* Known HIV infection with CD4 count \<200 / mm3, immunosuppression
* Patient already operated for TOA in progress
* TOA not accessible to vaginal puncture
* Multiple antecedents of abdominal surgeries that make it more difficult to surgically access the abdominopelvic cavity
* Pregnancy in progress or breastfeeding
* Patient with a contraindication to general anesthesia
* Poor understanding of the French language
* Patient under guardianship or curatorship
* Patient under AVK without relay by LMWH possible
* Known allergies or contraindic…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.