Efficacy of Transvaginal Ultrasound-guided Aspiration for Treatment of Tubo-ovarian Abscess Compared With Laparoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Cure rate
Study Overview
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%) 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.
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 cure rate (90 versus 65%) when antibiotic therapy is associated with abscess evacuation.
This TOA evacuation can be performed by surgery or by drainage. No studies have compared, even retrospectively, success rates between those two methods.
Current practices recommend performing conservative surgery by laparoscopy which allows a shorter hospital stay, a lower complication rate and high success rates (90%).
The majority of published studies reporting radiological drainage concern ultrasound-guided transvaginal drainage. The reported success rates range from 77 to 100%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •"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"
Arms & Interventions
Ultrasound-guided transvaginal drainage
evacuation of the TOA will be done by ultrasound-guided transvaginal puncture under simple sedation or under general anesthesia if necessary
Intervention: Ultrasound-guided transvaginal drainage (Procedure)
Laparoscopy
TOA will be evacuated by coelioscopy under general anesthesia
Intervention: Laparoscopy (Procedure)
Outcomes
Primary Outcomes
Cure rate
Time Frame: 6 weeks
"The cure rate is defined by a composite criterion at 6 weeks of the procedure: * No reoperation (puncture or coelioscopy) for TOA * No reintroduction of antibiotic therapy for TOA * Absence of latero uterine collection ≥ 3 cm on ultrasound"
Secondary Outcomes
- Number of days of hospital stay(6 weeks)
- Number of intra uterine pregnancy(2 years)
- Number of pregnancies obtained by in vitro fertilization(2 years)
- Pain self-assessment mesured by Visual Analog Scale the next day and 3 days after evacuation(the next day and 3 days after evacuation)
- Costs related to the hospital care of ATO at 6 weeks(6 weeks)
- Pregnancy rate in patients under 45 years of age at 2 years(2 years)
- Number of term of delivery(2 years)
- Rate of per operative complications (at 6 weeks) grade ≥ 2 (Clavien-Dindo classification)(6 weeks)
- numbers of adverse events(6 weeks)
- Number of pregnancy after tubal surgery(2 years)
- Rate of postoperative complications (at 6 weeks) grade ≥ 2 (Clavien-Dindo classification)(6 weeks)
- Number of spontaneous pregnancy(2 years)
- Health-related quality of life self-report mesured by EuroQol 5 Dimention(at baseline and at 6 weeks)
- Number of extra uterine pregnancy(2 years)