Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
NCT ID: NCT05408624
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2022-07-15
2024-12-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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prospective group - ultrasound transvaginal drainage
Patients with TOA with ultrasound-guided transvaginal drainage with outpatient management
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
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
laparoscopy
Laparoscopy for drainage of TOA under general anesthesia
Interventions
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ultrasound transvaginal drainage
Ultrasound-guided transvaginal drainage of TOA by a puncture under simple sedation or analgesia with/or under general anesthesia
laparoscopy
Laparoscopy for drainage of TOA under general anesthesia
Eligibility Criteria
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Inclusion Criteria
* Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
Exclusion Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Vincent DOCHEZ
Role: primary
Other Identifiers
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RC21_0011
Identifier Type: -
Identifier Source: org_study_id
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