Drainage of Tubo - Ovarian Abscess: DTOA

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Tubo-ovarian Abscess

Treatments: Procedure: laparoscopic approach; Procedure: transvaginal approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03166982

2016-A00961-50 (Other Identifier)

CHU-0283

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

laparoscopy

Experimental group

Description:

the tubo-ovarian abscess should be drained by interventional radiology, preferably by transvaginal or laparoscopic

Treatment:

Procedure: laparoscopic approach

ultrasound-guided puncture

Experimental group

Description:

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

Treatment:

Procedure: transvaginal approach