An observational study in Abscess, Pelvic Inflammatory Disease and Pelvic Infection, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Nantes University Hospital · Observational
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.
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.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 24 observational studies indexed under Abscess.
Browse Abscess studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient with severity criteria requiring hospitalization:
Patient with a formal indication for laparoscopy:
Patients with TOA with ultrasound-guided transvaginal drainage with outpatient management
Procedure: ultrasound transvaginal drainage
Patients with TOA in 2016, 2017 and 2018 with ultrasound-guided transvaginal drainage in conventional hospitalization
Procedure: ultrasound transvaginal drainage
Patients with TOA in 2016, 2017 and 2018 with laparoscopy in conventional hospitalization
Procedure: laparoscopy
Ultrasound-guided transvaginal drainage of TOA by a puncture under simple sedation or analgesia with/or under general anesthesia
Laparoscopy for drainage of TOA under general anesthesia
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
Time frame: one month
eligibility
Number of patients included in the protocol compared to the number of eligible patients
Time frame: 2 years
Discharge
Discharge from hospital within 24 hours of the drainage
Time frame: 2 years
Rehospitalization
Rehospitalization: reason, duration and care
Time frame: 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
Time frame: 1 month
residual mass
Absence of residual mass ≥ 3cm on pelvic ultrasound
Time frame: 1 month
complications
Presence of complications (digestive, urinary, parietal)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 month
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