Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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 (TOA). Recent recommendations published in December 2018 by the National College of French Gynecologists and Obstetricians (CNGOF) suggest that it is preferable to drain TOA when their size is greater than 3-4 cm. Ultrasound-guided transvaginal drainage is recommended as first-line treatment because of its ease of performance and its effectiveness. In the literature, many authors have demonstrated the feasibility and efficacy of transvaginal drainage associated with antibiotics in the treatment of TOA. Since ultrasound-guided transvaginal drainage is a less invasive alternative therapeutic procedure than laparoscopy for the drainage of TOA, it would be compatible with outpatient management. This mode of management can be carried out in a dedicated outpatient or functional exploration room with the help of a nurse but without an anesthetic team present. This gesture is simple and short-lived. In addition, the antibiotics used have pharmacological properties allowing oral intake from their initiation. The investigators have proposed a new service protocol to treat TOA in this outpatient mode. The investigators therefore wish to analyze this new protocol from these three angles: 1/ the feasibility of this care, 2/ the quality of life of the patients through questionnaires given throughout the care and 3/ an evaluation of the 'efficiency.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Major patient at the time of inclusion

• Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm

Locations
Other Locations
France
CHU Nantes
RECRUITING
Nantes
Contact Information
Primary
Dochez Vincent, MD
Vincent.DOCHEZ@chu-nantes.fr
02 40 08 78 00
Time Frame
Start Date: 2022-07-15
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 60
Treatments
prospective group - ultrasound transvaginal drainage
Patients with TOA with ultrasound-guided transvaginal drainage with outpatient management
retrospective group - ultrasound transvaginal drainage
Patients with TOA in 2016, 2017 and 2018 with ultrasound-guided transvaginal drainage in conventional hospitalization
retrospective group - laparoscopy
Patients with TOA in 2016, 2017 and 2018 with laparoscopy in conventional hospitalization
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov