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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants receive an intervention throughout the protocol
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Experimental: laparoscopy
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



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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

  4. Organic improvement [ Time Frame: at 72 hours and at 1 month ]
    CRP Standards and GB to 72 hours and 1 month if initially high


Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: at day 0 ]
  2. Analgesia Type: general anesthesia versus sedation [ Time Frame: at day 1 ]
  3. recurrent complications [ Time Frame: at day 1 ]
    Per Statement of complications and postoperative and rehospitalization

  4. Operating Time [ Time Frame: at day 1 ]
  5. Fertility prognosis by Mage score [ Time Frame: at 3 months ]
  6. prognosis of chronic pelvic pain score by adhesions at second look laparoscopy [ Time Frame: at 3 months ]


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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Patrick LACARIN 04 73 75 15 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
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         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Anne-Sophie GREMEAU University Hospital, Clermont-Ferrand

Publications:

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03166982     History of Changes
Other Study ID Numbers: CHU-0283
2016-A00961-50 ( Other Identifier: 2016-A00961-50 )
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: October 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Tubo-ovarian abscess
Transvaginal drainage
Laparoscopic treatment

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes