AbscessAmbATONCT05408624
Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
An observational study of Abscess and Pelvic Inflammatory Disease, run by Nantes University Hospital at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abscess, Pelvic Inflammatory Disease, Pelvic Infection
- What is being tested?
- ultrasound transvaginal drainage and laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
Who may be able to join
- Major patient at the time of inclusion
- Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
Who cannot join
- 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)
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Abscess, Pelvic Inflammatory Disease, Pelvic Infection
- Being tested
- ultrasound transvaginal drainage, laparoscopy
- Keywords
- Tubo-ovarian abscess, pelvic inflammatory disease, antibiotics, outpatient management, ultrasound-guided transvaginal drainage, laparoscopy
- Medical subject headings
- Abscess, Pelvic Inflammatory Disease, Pelvic Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound transvaginal drainageProcedure or surgery
Ultrasound-guided transvaginal drainage of TOA by a puncture under simple sedation or analgesia with/or under general anesthesia
laparoscopyProcedure or surgery
Laparoscopy for drainage of TOA under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| prospective group - ultrasound transvaginal drainage | Patients with TOA with ultrasound-guided transvaginal drainage with outpatient management Receives: Procedure: ultrasound transvaginal drainage | |
| retrospective group - ultrasound transvaginal drainage | Patients with TOA in 2016, 2017 and 2018 with ultrasound-guided transvaginal drainage in conventional hospitalization Receives: Procedure: ultrasound transvaginal drainage | |
| retrospective group - laparoscopy | Patients with TOA in 2016, 2017 and 2018 with laparoscopy in conventional hospitalization Receives: Procedure: laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Secondary outcomes (11)
eligibility
Number of patients included in the protocol compared to the number of eligible patients
Measured: 2 years
Discharge
Discharge from hospital within 24 hours of the drainage
Measured: 2 years
Rehospitalization
Rehospitalization: reason, duration and care
Measured: 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
Measured: 1 month
residual mass
Absence of residual mass ≥ 3cm on pelvic ultrasound
Measured: 1 month
complications
Presence of complications (digestive, urinary, parietal)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbscessStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408624
- Sponsor's protocol ID
- RC21_0011
- Acronym
- AmbATO
- Status last verified
- Mar 2024
- First submitted
- 23 May 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
- ClinicalTrials.gov ID
- NCT05408624
- Acronym / sponsor ID
- AmbATO / RC21_0011
- Conditions
- Abscess, Pelvic Inflammatory Disease, Pelvic Infection
- Keywords
- Tubo-ovarian abscess, pelvic inflammatory disease, antibiotics, outpatient management, ultrasound-guided transvaginal drainage, laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prospective group - ultrasound transvaginal drainage | – | Procedure: ultrasound transvaginal drainagePatients with TOA with ultrasound-guided transvaginal drainage with outpatient management |
| retrospective group - ultrasound transvaginal drainage | – | Procedure: ultrasound transvaginal drainagePatients with TOA in 2016, 2017 and 2018 with ultrasound-guided transvaginal drainage in conventional hospitalization |
| retrospective group - laparoscopy | – | Procedure: laparoscopyPatients with TOA in 2016, 2017 and 2018 with laparoscopy in conventional hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
Key inclusion criteria (2 listed)
- Major patient at the time of inclusion
- Patient with diagnosis of TOA with a latero-uterine mass measuring at least 3 cm
Key exclusion criteria (13 listed)
- Patient with severity criteria requiring hospitalization:
- Patient with a formal indication for laparoscopy:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound transvaginal drainageUltrasound-guided transvaginal drainage of TOA by a puncture under simple sedation or analgesia with/or under general anesthesia | Procedure or surgery | prospective group - ultrasound transvaginal drainage, retrospective group - ultrasound transvaginal drainage |
| laparoscopyLaparoscopy for drainage of TOA under general anesthesia | Procedure or surgery | retrospective group - laparoscopy |
Primary outcome
Cure rate
Time frame: 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
11 secondary outcomes
eligibility
Time frame: 2 years
Discharge
Time frame: 2 years
Rehospitalization
Time frame: 1 month
Measure of Pain
Time frame: 1 month
residual mass
Time frame: 1 month
complications
Time frame: 1 month
antibiotic therapy
Time frame: 1 month
Quality of life with EQ-5D-5L
Time frame: 1 month
Quality of life with Medical Outcome Study Short Form 12 (SF12)
Time frame: 1 month
Quality of life with Patient Global Impression of Improvement (PGI-I) questionnaires
Time frame: 1 month
Evaluation of the direct costs
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abscess and Pelvic Inflammatory Disease, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dochez Vincent, MD (02 40 08 78 00 ext. +33, Vincent.DOCHEZ@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.