Status:
COMPLETED
Efficacy of Transvaginal Ultrasound-guided Aspiration for Treatment of Tubo-ovarian Abscess Compared With Laparoscopy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Uncomplicated Tubo Ovarian Abscess
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief 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%...
Detailed Description
"Tubo-ovarian abscess (TOA) include pyosalpinx, ovarian abscess, tubo-ovarian abscess and Douglas abscess from genital organs. The only randomized study evaluating TOA treatment reported a higher cur...
Eligibility Criteria
Inclusion
- "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 contraindications to any of the drugs used in the research
- Patient participating in another interventional research protocol
- No affiliation to the social security scheme or the CMU (universal health cover)
- Absence of informed consent, written and signed"
Exclusion
Key Trial Info
Start Date :
April 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT03819309
Start Date
April 30 2019
End Date
June 11 2025
Last Update
January 8 2026
Active Locations (1)
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1
Hôpital Bichat-Claude Bernard
Paris, France, 75018