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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05408624
Other study ID # RC21_0011
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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