Informations générales (source: ClinicalTrials.gov)
Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority (DTOA)
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
octobre 2016
décembre 2018
29 juin 2024
The treatment of the acute phase of the complicated abscess tubo-ovarian relies on
antibiotics more or less associated with surgical management in case of visible abscess,
poor clinical tolerance (sepsis) and resistance to medical treatment. The CNGOF
recommended in 2012 that the tubo-ovarian abscess are not within one antibiotic, and
should be drained by interventional radiology, preferably by transvaginal or
laparoscopic.
Furthermore the efficiency of drainage by ultrasound puncture performed vaginally was
demonstrated. This approach tends to replace the first laparoscopy because of its less
invasive, fast, easy to access, more acceptable and less cost compared to laparoscopy.
This approach is recommended by the French and English colleges.
In total, the surgery in case of ATO is necessary, it is always coupled with antibiotics.
Several surgical approaches are possible, laparotomy, laparoscopy and ultrasound-guided
puncture. No prospective comparative study has been done, for which we want to develop
this study.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Patients with a IGH with tubo-ovarian abscess visible on ultrasound or CT
- Ultrasound abscess> or equal to 2cm
- Abdominal pain syndrome
- Age 18 to 43 years
- understand french language
- No complicated: good hemodynamic tolerance, not broken
- These patients should be affiliated to the French Social Security and must have
given informed participation agreement
- Patients with a IGH with tubo-ovarian abscess visible on ultrasound or CT
- Ultrasound abscess> or equal to 2cm
- Abdominal pain syndrome
- Age 18 to 43 years
- understand french language
- No complicated: good hemodynamic tolerance, not broken
- These patients should be affiliated to the French Social Security and must have
given informed participation agreement
Patients with HIV (CD4 <200) or co-infections: immunosuppression
- Multi-Abdomen surgery
- Suspected malignant or borderline tumor
- Complicated abscess: rupture of the abscess, peritonitis, septic shock
- Postoperative pelvic abscess
- Patient minor
- During Pregnancy
- Patient having already been accounted for tubo-ovarian abscess in progress
- Not accessible abscess transvaginal puncture
- Patients unable major, patients suffering from mental pathology incompatible with
informed consent, refusal to participate