Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Conditions
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Abscess, Pelvic Inflammatory Disease, Pelvic Infection

Intervention / Treatment
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* Procedure: ultrasound transvaginal drainage
* Procedure: laparoscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tubo-ovarian abscess, pelvic inflammatory disease, antibiotics, outpatient management, ultrasound-guided transvaginal drainage, laparoscopy