Status:

RECRUITING

Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Lead Sponsor:

Nantes University Hospital

Conditions:

Abscess

Pelvic Inflammatory Disease

Eligibility:

FEMALE

18+ years

Brief Summary

Pelvic inflammatory diseases (PID) require antibiotic treatment. Among PID, the investigators distinguish: pelvi-peritonitis and pelvic collections such as Douglas abscess and/or tubo-ovarian abscess ...

Detailed Description

Pelvic inflammatory diseases (PID) require antibiotic treatment. Among PID, the investigators distinguish: pelvi-peritonitis and pelvic collections such as Douglas abscess and/or tubo-ovarian abscess ...

Eligibility Criteria

Inclusion

  • Major patient at the time of inclusion
  • Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm

Exclusion

  • Patient with severity criteria requiring hospitalization:
  • Clinical severity criteria: haemodynamically unstable patient, septic shock, defense or contracture, sepsis, pelviperitonitis
  • Comorbidities: diabetic imbalance, curative anticoagulation
  • Patient with a formal indication for laparoscopy:
  • Diagnostic doubt with suspicion of an associated oncological or digestive pathology
  • Presence of an intra-abdominal intrauterine device (IUD)
  • Abscess not accessible vaginally
  • Patient who does not meet the eligibility criteria for outpatient hospitalization defined by French High Autority of Health
  • Patient under guardianship or curatorship
  • Patient does not speak French
  • Patient not benefiting from social security coverage
  • Current pregnancy
  • Confirmed allergy to one of the antibiotics (ceftriaxone, metronidazole or doxycycline)

Key Trial Info

Start Date :

July 15 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05408624

Start Date

July 15 2022

End Date

December 1 2024

Last Update

March 21 2024

Active Locations (1)

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1

CHU Nantes

Nantes, France