Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Abscess Clinical Trial

— AmbATO  

Official title:

Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408624
• Other study ID #: RC21_0011
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Nantes University Hospital
• Contact: Dochez Vincent, MD
• Phone: 02 40 08 78 00
• Email: Vincent.DOCHEZ[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Abscess
• Pelvic Inflammatory Disease

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	eligibility	Number of patients included in the protocol compared to the number of eligible patients	2 years
Secondary	Discharge	Discharge from hospital within 24 hours of the drainage	2 years
Secondary	Rehospitalization	Rehospitalization: reason, duration and care	1 month
Secondary	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
Secondary	residual mass	Absence of residual mass = 3cm on pelvic ultrasound	1 month
Secondary	complications	Presence of complications (digestive, urinary, parietal)	1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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