Outpatient management of tubo-ovarian abscesses
Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
This study is testing a new way to treat tubo-ovarian abscesses at home using ultrasound-guided drainage and antibiotics to see if it works better than surgery and helps patients feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT05408624 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new outpatient protocol for managing tubo-ovarian abscesses (TOA) using ultrasound-guided transvaginal drainage combined with antibiotic treatment. The approach aims to provide a less invasive alternative to traditional surgical methods, allowing patients to receive care without hospitalization. The study will assess the feasibility of this outpatient management, as well as its impact on patients' quality of life through questionnaires. The protocol is based on recent guidelines recommending drainage for larger abscesses and aims to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adult patients diagnosed with a tubo-ovarian abscess measuring at least 3 cm who do not have severe comorbidities or indications for hospitalization.
Not a fit: Patients with severe conditions requiring hospitalization, such as septic shock or those with certain comorbidities, will not benefit from this outpatient management approach.
Why it matters
Potential benefit: If successful, this approach could provide a more accessible and less invasive treatment option for patients with tubo-ovarian abscesses.
How similar studies have performed: Previous studies have shown the feasibility and effectiveness of ultrasound-guided transvaginal drainage for tubo-ovarian abscesses, indicating that this approach is supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nantes
- CHU Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Dochez Vincent, MD
- Email: Vincent.DOCHEZ@chu-nantes.fr
- Phone: 02 40 08 78 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.