Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Last updated: March 20, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Vaginal Infection

Gynecological Infections

Treatment

laparoscopy

ultrasound transvaginal drainage

Clinical Study ID

NCT05408624
RC21_0011
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

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

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 digestivepathology
  • Presence of an intra-abdominal intrauterine device (IUD)
  • Abscess not accessible vaginally
  • Patient who does not meet the eligibility criteria for outpatient hospitalizationdefined 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 ordoxycycline)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: laparoscopy
Phase:
Study Start date:
July 15, 2022
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

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