Efficacy of Transvaginal Ultrasound-guided Aspiration for Treatment of Tubo-ovarian Abscess Compared With Laparoscopy

NCT03819309 | Completed

• 1 other identifier: K170917J
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncomplicated Tubo Ovarian Abscess

Keywords

tubo ovarian abscess; transvaginal aspiration; laparoscopy

Outcome Measures

Primary Outcomes (1)

• Cure rate

  "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"

  6 weeks

Secondary Outcomes (14)

• Number of days of hospital stay

  6 weeks

• 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 intra uterine pregnancy

  2 years

• Number of extra uterine pregnancy

  2 years

Study Arms (2)

Ultrasound-guided transvaginal drainage

EXPERIMENTAL

evacuation of the TOA will be done by ultrasound-guided transvaginal puncture under simple sedation or under general anesthesia if necessary

Procedure: Ultrasound-guided transvaginal drainage

Laparoscopy

ACTIVE COMPARATOR

TOA will be evacuated by coelioscopy under general anesthesia

Procedure: Laparoscopy

Interventions

Ultrasound-guided transvaginal drainage PROCEDURE

evacuation of the TOA will be done by ultrasound-guided transvaginal puncture under simple sedation or under general anesthesia if necessary

Ultrasound-guided transvaginal drainage

Laparoscopy PROCEDURE

TOA will be evacuated by coelioscopy under general anesthesia

Laparoscopy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Martin Koskas, M.D. Ph.D.

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 28, 2019
• Study Start: April 30, 2019
• Primary Completion: June 13, 2023
• Study Completion: June 11, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

FR (1)