Tubo-ovarian Abscess Clinical Trial
Official title:
Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority
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.
Retrospective studies evaluating the efficacy of these two supported relate the same cure
rates between the two techniques. According to the literature of Garbin O.and al in 2012,
the success rate of transvaginal puncture is generally 93.6%. The largest series of Gjelland
al in 2005 and covers 302 consecutive patients with ATO who underwent triple antibiotic
therapy and transvaginal puncture, the success rate was 93.4%. The failures that required
surgical management have frequently revealed endometriosis or cancer. To support
laparoscopic, Raiga and al in 1996 studied the support of 36 retrospectively patients who
underwent laparoscopic incisional and wash the abscess with a success rate of 100%. Moreover
Reich and al in 1987 found 90% success on a review of 25 patients.
The transvaginal echo guided puncture to replace the first laparoscopy because of its less
invasive nature, this is a simple act, fast, possible under mild sedation, the cost is still
lower than laparoscopy. Some uncontrolled retrospective studies suggest that laparoscopy
remains associated with prolongation of hospitalization time, it is also mentioned that the
transvaginal puncture is better tolerated by the patient.
No study has compared these two techniques, which is why we propose this study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04817631 -
Management of Tubo-ovarian Abscess: a Single Center Experience
|