Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Major patient at the time of inclusion
- •Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
排除标准
- •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)
结局指标
主要结局
Cure rate
时间窗: one month
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
次要结局
- eligibility(2 years)
- Discharge(2 years)
- antibiotic therapy(1 month)
- Quality of life with Medical Outcome Study Short Form 12 (SF12)(1 month)
- Quality of life with EQ-5D-5L(1 month)
- Measure of Pain(1 month)
- residual mass(1 month)
- Rehospitalization(1 month)
- complications(1 month)
- Quality of life with Patient Global Impression of Improvement (PGI-I) questionnaires(1 month)
- Evaluation of the direct costs(1 month)