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

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.

Study Overview

• Status: Recruiting
• Conditions: Abscess; Pelvic Inflammatory Disease; Pelvic Infection
• Intervention / Treatment: Procedure: ultrasound transvaginal drainage; Procedure: laparoscopy

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Dochez Vincent, MD; Phone Number: +33 02 40 08 78 00; Email: Vincent.DOCHEZ@chu-nantes.fr

Study Locations

• France
  • Nantes, France
    • Recruiting
    • Chu Nantes
    • Contact: Vincent DOCHEZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
prospective group - ultrasound transvaginal drainage; Patients with TOA with ultrasound-guided transvaginal drainage with outpatient management	Procedure: ultrasound transvaginal drainage; Ultrasound-guided transvaginal drainage of TOA by a puncture under simple sedation or analgesia with/or under general anesthesia
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; Ultrasound-guided transvaginal drainage of TOA by a puncture under simple sedation or analgesia with/or under general anesthesia
retrospective group - laparoscopy; Patients with TOA in 2016, 2017 and 2018 with laparoscopy in conventional hospitalization	Procedure: laparoscopy; Laparoscopy for drainage of TOA under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
eligibility	Number of patients included in the protocol compared to the number of eligible patients	2 years
Discharge	Discharge from hospital within 24 hours of the drainage	2 years
Rehospitalization	Rehospitalization: reason, duration and care	1 month
Measure of Pain	Pain is assessed by Numerical Rating Scale (NRS) (0-10). Absence of pain (EN=0/10), mild pain (EN<4/10), absence of metrorrhagia and absence of leucorrhoea	1 month
residual mass	Absence of residual mass ≥ 3cm on pelvic ultrasound	1 month
complications	Presence of complications (digestive, urinary, parietal)	1 month
antibiotic therapy	Change of antibiotic therapy (except adequate adaptation to the antibiogram). Change of antibiotic therapy is assessed by the need to add another antibiotic with a broader spectrum of action, following a poor clinical or biological evolution.	1 month
Quality of life with EQ-5D-5L	Satisfaction and Quality of life completed by the patients on the day of the drainage before the procedure, at 48 hours and at 1 month	1 month
Quality of life with Medical Outcome Study Short Form 12 (SF12)	Satisfaction and Quality of life, questionnaires completed by the patients on the day of the drainage before the procedure, at 48 hours and at 1 month. Each question is assessed on a Likert scale, with 5 to 6 possible levels of response possible responses. The 8 dimensions combine synthetic information to calculate a physical composite score (PCS) and a mental score (SCP) and a mental composite score (SCM). The higher the score, the greater the patient's ability.	1 month
Quality of life with Patient Global Impression of Improvement (PGI-I) questionnaires	Satisfaction and Quality of life , questionnaires completed by the patients on the day of the drainage before the procedure, at 48 hours and at 1 month The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.	1 month
Evaluation of the direct costs	Evaluation of the direct costs of care for the 3 treatment strategies for complicated IGH of the ATO type, according to a time horizon of 1 month and a collective perspective	1 month

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopy; antibiotics; Tubo-ovarian abscess; pelvic inflammatory disease; outpatient management; ultrasound-guided transvaginal drainage
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Adnexal Diseases; Suppuration; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Abscess; Pelvic Inflammatory Disease; Pelvic Infection
• Other Study ID Numbers: RC21_0011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No