Drainage of Tubo - Ovarian Abscess: DTOA (DTOA)
Primary Purpose
Tubo-ovarian Abscess
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transvaginal approach
laparoscopic approach
Sponsored by
About this trial
This is an interventional treatment trial for Tubo-ovarian Abscess focused on measuring Tubo-ovarian abscess, Transvaginal drainage, Laparoscopic treatment
Eligibility 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
Sites / Locations
- CHU Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
laparoscopy
ultrasound-guided puncture
Arm Description
the tubo-ovarian abscess should be drained by interventional radiology, preferably by transvaginal or laparoscopic
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
Outcomes
Primary Outcome Measures
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.)
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.)
Clinical improvement
apyrexia to 72 hours and 1 month and EVA to 72 hours and 1 month
Organic improvement
CRP Standards and GB to 72 hours and 1 month if initially high
Secondary Outcome Measures
Duration of hospital stay
Analgesia Type: general anesthesia versus sedation
recurrent complications
Per Statement of complications and postoperative and rehospitalization
Operating Time
Fertility prognosis by Mage score
prognosis of chronic pelvic pain score by adhesions at second look laparoscopy
Full Information
NCT ID
NCT03166982
First Posted
October 10, 2016
Last Updated
May 23, 2017
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT03166982
Brief Title
Drainage of Tubo - Ovarian Abscess: DTOA
Acronym
DTOA
Official Title
Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tubo-ovarian Abscess
Keywords
Tubo-ovarian abscess, Transvaginal drainage, Laparoscopic treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants receive an intervention throughout the protocol
Masking
None (Open Label)
Masking Description
Open
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laparoscopy
Arm Type
Experimental
Arm Description
the tubo-ovarian abscess should be drained by interventional radiology, preferably by transvaginal or laparoscopic
Arm Title
ultrasound-guided puncture
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
transvaginal approach
Intervention Type
Procedure
Intervention Name(s)
laparoscopic approach
Primary Outcome Measure Information:
Title
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
Title
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
Title
Clinical improvement
Description
apyrexia to 72 hours and 1 month and EVA to 72 hours and 1 month
Time Frame
at 72 hours and at 1 month
Title
Organic improvement
Description
CRP Standards and GB to 72 hours and 1 month if initially high
Time Frame
at 72 hours and at 1 month
Secondary Outcome Measure Information:
Title
Duration of hospital stay
Time Frame
at day 0
Title
Analgesia Type: general anesthesia versus sedation
Time Frame
at day 1
Title
recurrent complications
Description
Per Statement of complications and postoperative and rehospitalization
Time Frame
at day 1
Title
Operating Time
Time Frame
at day 1
Title
Fertility prognosis by Mage score
Time Frame
at 3 months
Title
prognosis of chronic pelvic pain score by adhesions at second look laparoscopy
Time Frame
at 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 15 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie GREMEAU
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Michel CANIS, PUPH
First Name & Middle Initial & Last Name & Degree
Jean-Luc POULY, PUPH
First Name & Middle Initial & Last Name & Degree
Benoit RABISCHONG, PUPH
First Name & Middle Initial & Last Name & Degree
Nicolas BOURDEL, PH
First Name & Middle Initial & Last Name & Degree
Sandra CURINIER, PH
First Name & Middle Initial & Last Name & Degree
Martine BONIN, PH
First Name & Middle Initial & Last Name & Degree
Candice CHAUFFOUR, CCA
First Name & Middle Initial & Last Name & Degree
Adrien TRAN MAU THEM, CCA
First Name & Middle Initial & Last Name & Degree
Nicolas AGAR, CCA
12. IPD Sharing Statement
Citations:
PubMed Identifier
16202721
Citation
Gjelland K, Ekerhovd E, Granberg S. Transvaginal ultrasound-guided aspiration for treatment of tubo-ovarian abscess: a study of 302 cases. Am J Obstet Gynecol. 2005 Oct;193(4):1323-30. doi: 10.1016/j.ajog.2005.06.019.
Results Reference
background
PubMed Identifier
19230781
Citation
Granberg S, Gjelland K, Ekerhovd E. The management of pelvic abscess. Best Pract Res Clin Obstet Gynaecol. 2009 Oct;23(5):667-78. doi: 10.1016/j.bpobgyn.2009.01.010. Epub 2009 Feb 20.
Results Reference
background
PubMed Identifier
8844136
Citation
Gerber B, Krause A. A study of second-look laparoscopy after acute salpingitis. Arch Gynecol Obstet. 1996;258(4):193-200. doi: 10.1007/s004040050123.
Results Reference
background
PubMed Identifier
1835469
Citation
Le Bouedec G, Pouly JL, Canis M, Wattiez A, Abbas B, Mage G, Bruhat MA. [Acute salpingitis. Celioscopy before and after treatment: 110 cases]. J Gynecol Obstet Biol Reprod (Paris). 1991;20(5):680-4. French.
Results Reference
background
PubMed Identifier
8893672
Citation
Raiga J, Canis M, Le Bouedec G, Glowaczower E, Pouly JL, Mage G, Bruhat MA. Laparoscopic management of adnexal abscesses: consequences for fertility. Fertil Steril. 1996 Nov;66(5):712-7. doi: 10.1016/s0015-0282(16)58623-3.
Results Reference
background
PubMed Identifier
14504870
Citation
Heinonen PK, Leinonen M. Fecundity and morbidity following acute pelvic inflammatory disease treated with doxycycline and metronidazole. Arch Gynecol Obstet. 2003 Oct;268(4):284-8. doi: 10.1007/s00404-002-0376-6. Epub 2002 Oct 26.
Results Reference
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PubMed Identifier
21844746
Citation
Trent M, Bass D, Ness RB, Haggerty C. Recurrent PID, subsequent STI, and reproductive health outcomes: findings from the PID evaluation and clinical health (PEACH) study. Sex Transm Dis. 2011 Sep;38(9):879-81. doi: 10.1097/OLQ.0b013e31821f918c.
Results Reference
background
PubMed Identifier
12015517
Citation
Ness RB, Soper DE, Holley RL, Peipert J, Randall H, Sweet RL, Sondheimer SJ, Hendrix SL, Amortegui A, Trucco G, Songer T, Lave JR, Hillier SL, Bass DC, Kelsey SF. Effectiveness of inpatient and outpatient treatment strategies for women with pelvic inflammatory disease: results from the Pelvic Inflammatory Disease Evaluation and Clinical Health (PEACH) Randomized Trial. Am J Obstet Gynecol. 2002 May;186(5):929-37. doi: 10.1067/mob.2002.121625.
Results Reference
background
PubMed Identifier
2107687
Citation
Abbitt PL, Goldwag S, Urbanski S. Endovaginal sonography for guidance in draining pelvic fluid collections. AJR Am J Roentgenol. 1990 Apr;154(4):849-50. doi: 10.2214/ajr.154.4.2107687. No abstract available.
Results Reference
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PubMed Identifier
11080409
Citation
Buchweitz O, Malik E, Kressin P, Meyhoefer-Malik A, Diedrich K. Laparoscopic management of tubo-ovarian abscesses: retrospective analysis of 60 cases. Surg Endosc. 2000 Oct;14(10):948-50. doi: 10.1007/s004640000249.
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PubMed Identifier
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Citation
Henry-Suchet J, Soler A, Loffredo V. Laparoscopic treatment of tuboovarian abscesses. J Reprod Med. 1984 Aug;29(8):579-82. No abstract available.
Results Reference
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PubMed Identifier
23146745
Citation
Garbin O, Verdon R, Fauconnier A. [Treatment of the tubo-ovarian abscesses]. J Gynecol Obstet Biol Reprod (Paris). 2012 Dec;41(8):875-85. doi: 10.1016/j.jgyn.2012.09.012. Epub 2012 Nov 10. French.
Results Reference
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PubMed Identifier
8807761
Citation
Perez-Medina T, Huertas MA, Bajo JM. Early ultrasound-guided transvaginal drainage of tubo-ovarian abscesses: a randomized study. Ultrasound Obstet Gynecol. 1996 Jun;7(6):435-8. doi: 10.1046/j.1469-0705.1996.07060435.x.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Drainage of Tubo - Ovarian Abscess: DTOA
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