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 range18 Years – 50 Years
SexFEMALE
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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…