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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00961-50 | Other Identifier | 2016-A00961-50 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopy | Experimental | the tubo-ovarian abscess should be drained by interventional radiology, preferably by transvaginal or laparoscopic |
|
| ultrasound-guided puncture | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transvaginal approach | Procedure |
| ||
| laparoscopic approach |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 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.) | at 1 month | |
| Clinical improvement | apyrexia to 72 hours and 1 month and EVA to 72 hours and 1 month | at 72 hours and at 1 month |
| Organic improvement | CRP Standards and GB to 72 hours and 1 month if initially high | at 72 hours and at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | at day 0 | |
| Analgesia Type: general anesthesia versus sedation | at day 1 | |
| recurrent complications |
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Inclusion Criteria:
Exclusion Criteria:
Patients with HIV (CD4 <200) or co-infections: immunosuppression
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 15 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Sophie GREMEAU | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16202721 | Background | 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. | |
| 19230781 | Background | 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. |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Participants receive an intervention throughout the protocol
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Open
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| Procedure |
|
Per Statement of complications and postoperative and rehospitalization |
| at day 1 |
| Operating Time | at day 1 |
| Fertility prognosis by Mage score | at 3 months |
| prognosis of chronic pelvic pain score by adhesions at second look laparoscopy | at 3 months |
| 8844136 | Background | 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. |
| 1835469 | Background | 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. |
| 8893672 | Background | 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. |
| 14504870 | Background | 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. |
| 21844746 | Background | 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. |
| 12015517 | Background | 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. |
| 2107687 | Background | 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. |
| 11080409 | Background | 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. |
| 6237196 | Background | Henry-Suchet J, Soler A, Loffredo V. Laparoscopic treatment of tuboovarian abscesses. J Reprod Med. 1984 Aug;29(8):579-82. No abstract available. |
| 23146745 | Background | 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. |
| 8807761 | Background | 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. |
| 26096351 | Background | Vermersch C, Dessein R, Lucot JP, Rubod C, Cosson M, Giraudet G. [Tubo-ovarian abscesses treatment: Faisability and results of trans-vaginal ultrasound-guided aspiration]. J Gynecol Obstet Biol Reprod (Paris). 2016 Mar;45(3):243-8. doi: 10.1016/j.jgyn.2015.04.016. Epub 2015 Jun 19. French. |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |