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Less invasive drainage may match surgery for abscess treatment
NCT ID NCT03819309
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tested whether a less invasive ultrasound-guided drainage procedure works as well as laparoscopic surgery for treating tubo-ovarian abscess. 208 women with uncomplicated abscess were randomly assigned to one of the two procedures, both combined with antibiotics. The main goal was to see if the drainage could achieve a similar cure rate at 6 weeks, defined by no need for further surgery or antibiotics and no large collection on ultrasound.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ultrasound-guided transvaginal drainage or laparoscopy
- What this could lead to
- If successful, this could show that a less invasive drainage procedure works as well as surgery for treating tubo-ovarian abscess, potentially reducing recovery time and complications.
- What could go wrong
- This is a completed trial, but results are not yet widely known. The non-inferiority design means it may not prove drainage is truly as good as laparoscopy, and individual outcomes vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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208 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
"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"
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Bichat-Claude Bernard
Paris, 75018, France