Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

NCT05408624 | Recruiting

• 1 other identifier: RC21_0011
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Abscess; Pelvic Inflammatory Disease; Pelvic Infection

Keywords

Tubo-ovarian abscess; pelvic inflammatory disease; antibiotics; outpatient management; ultrasound-guided transvaginal drainage; laparoscopy

Outcome Measures

Primary Outcomes (1)

• Cure rate

  The cure rate is defined by a composite criterion at 1 month of the procedure: * Apyrexia (temperature \<38,0°c) * Absence of re-intervention for pelvic collection (TOA) in the month following the transvaginal drainage * Absence of second-line antibiotic therapy, extension, new antibiotic in the month following the transvaginal drainage

  one month

Secondary Outcomes (11)

• eligibility

  2 years

• Discharge

  2 years

• Rehospitalization

  1 month

• Measure of Pain

  1 month

• residual mass

  1 month

Study Arms (3)

prospective group - ultrasound transvaginal drainage

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

Procedure: ultrasound transvaginal drainage

retrospective group - ultrasound transvaginal drainage

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

Procedure: ultrasound transvaginal drainage

retrospective group - laparoscopy

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

Procedure: laparoscopy

Interventions

ultrasound transvaginal drainage PROCEDURE

Ultrasound-guided transvaginal drainage of TOA by a puncture under simple sedation or analgesia with/or under general anesthesia

prospective group - ultrasound transvaginal drainage; retrospective group - ultrasound transvaginal drainage

laparoscopy PROCEDURE

Laparoscopy for drainage of TOA under general anesthesia

retrospective group - laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, France

RECRUITING

MeSH Terms

Conditions

Abscess; Pelvic Inflammatory Disease; Pelvic Infection

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Dochez Vincent, MD

CONTACT

02 40 08 78 00; Vincent.DOCHEZ@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 7, 2022
• Study Start: July 15, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

FR (1)