Drainage of Tubo - Ovarian Abscess: DTOA (DTOA)
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|ClinicalTrials.gov Identifier: NCT03166982|
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Tubo-ovarian Abscess||Procedure: transvaginal approach Procedure: laparoscopic approach||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants receive an intervention throughout the protocol|
|Masking:||None (Open Label)|
|Official Title:||Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority|
|Actual Study Start Date :||October 26, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
the tubo-ovarian abscess should be drained by interventional radiology, preferably by transvaginal or laparoscopic
Procedure: laparoscopic approach
Experimental: ultrasound-guided puncture
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
Procedure: transvaginal approach
- Clinical cure rate defined by a composite score as defined by O'Brien PC (Procedures for Comparing samples with multiple endpoints Biometrics 1984; 40: 1079-1087.) [ Time Frame: at 72 hour ]
- Clinical cure rate defined by a composite score as defined by O'Brien PC (Procedures for Comparing samples with multiple endpoints Biometrics 1984; 40: 1079-1087.) [ Time Frame: at 1 month ]
- Clinical improvement [ Time Frame: at 72 hours and at 1 month ]apyrexia to 72 hours and 1 month and EVA to 72 hours and 1 month
- Organic improvement [ Time Frame: at 72 hours and at 1 month ]CRP Standards and GB to 72 hours and 1 month if initially high
- Duration of hospital stay [ Time Frame: at day 0 ]
- Analgesia Type: general anesthesia versus sedation [ Time Frame: at day 1 ]
- recurrent complications [ Time Frame: at day 1 ]Per Statement of complications and postoperative and rehospitalization
- Operating Time [ Time Frame: at day 1 ]
- Fertility prognosis by Mage score [ Time Frame: at 3 months ]
- prognosis of chronic pelvic pain score by adhesions at second look laparoscopy [ Time Frame: at 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166982
|Contact: Patrick LACARIN||04 73 75 15 firstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 email@example.com|
|Sub-Investigator: Michel CANIS, PUPH|
|Sub-Investigator: Jean-Luc POULY, PUPH|
|Sub-Investigator: Benoit RABISCHONG, PUPH|
|Sub-Investigator: Nicolas BOURDEL, PH|
|Sub-Investigator: Sandra CURINIER, PH|
|Sub-Investigator: Martine BONIN, PH|
|Sub-Investigator: Candice CHAUFFOUR, CCA|
|Sub-Investigator: Adrien TRAN MAU THEM, CCA|
|Sub-Investigator: Nicolas AGAR, CCA|
|Principal Investigator:||Anne-Sophie GREMEAU||University Hospital, Clermont-Ferrand|