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Search / Trial NCT05408624

Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Launched by NANTES UNIVERSITY HOSPITAL · Jun 3, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Tubo Ovarian Abscess Pelvic Inflammatory Disease Antibiotics Outpatient Management Ultrasound Guided Transvaginal Drainage Laparoscopy

ClinConnect Summary

This clinical trial is studying a new way to treat tubo-ovarian abscesses (TOA), which are painful infections in the pelvic area often caused by pelvic inflammatory disease (PID). The researchers want to see if they can safely manage this condition in an outpatient setting, meaning patients could receive treatment without needing to stay in the hospital. The focus is on using a method called ultrasound-guided transvaginal drainage, which is a less invasive procedure to drain the abscess, along with antibiotics that can be taken orally.

To be eligible for this trial, participants must be adult women diagnosed with a TOA that is at least 3 centimeters in size. However, those with more severe health issues or conditions that require hospitalization, such as severe infections or complications from other diseases, cannot participate. Throughout the study, participants will fill out questionnaires to help the researchers understand how the treatment impacts their quality of life and how well it works. This trial aims to provide a simpler, more effective way to treat TOA, which could lead to better outcomes for patients.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Major patient at the time of inclusion
  • Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
  • Exclusion Criteria:
  • * 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)

About Nantes University Hospital

Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.

Locations

Nantes, , France

Nantes, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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