Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses (AmbATO)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Pelvic Inflammatory Disease; Pelvic Infection; Abscess

Treatments: Procedure: ultrasound transvaginal drainage; Procedure: laparoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05408624

RC21_0011

Details and patient eligibility

About

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.

Full 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 (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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

60 participants in 3 patient groups

prospective group - ultrasound transvaginal drainage

Description:

Patients with TOA with ultrasound-guided transvaginal drainage with outpatient management

Treatment:

Procedure: ultrasound transvaginal drainage

retrospective group - ultrasound transvaginal drainage

Description:

Patients with TOA in 2016, 2017 and 2018 with ultrasound-guided transvaginal drainage in conventional hospitalization

Treatment:

Procedure: ultrasound transvaginal drainage

retrospective group - laparoscopy

Description:

Patients with TOA in 2016, 2017 and 2018 with laparoscopy in conventional hospitalization

Treatment:

Procedure: laparoscopy