Clinical trial NCT05408624: Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
Official title: Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abscess
Pelvic Inflammatory Disease
Pelvic Infection
Keywords: Tubo-ovarian abscess
pelvic inflammatory disease
antibiotics
outpatient management
ultrasound-guided transvaginal drainage
laparoscopy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm

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 (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.

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 (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 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)

Primary outcomes:
measure: Cure rate
timeFrame: one month
Secondary outcomes:
measure: eligibility
timeFrame: 2 years
measure: Discharge
timeFrame: 2 years
measure: Rehospitalization
timeFrame: 1 month
measure: Measure of Pain
timeFrame: 1 month
measure: residual mass
timeFrame: 1 month
measure: complications
timeFrame: 1 month
measure: antibiotic therapy
timeFrame: 1 month
measure: Quality of life with EQ-5D-5L
timeFrame: 1 month
measure: Quality of life with Medical Outcome Study Short Form 12 (SF12)
timeFrame: 1 month
measure: Quality of life with Patient Global Impression of Improvement (PGI-I) questionnaires
timeFrame: 1 month
measure: Evaluation of the direct costs
timeFrame: 1 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References: