NCT03166982|Unknown
Drainage of Tubo - Ovarian Abscess: DTOA
DTOA
Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority
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DTOA
Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority
Sponsor study identifier
Secondary identifiers
OTHER · 2016-A00961-50
interventional
80
1 country
1
Study Start
October 26, 2016
Actual (reported)Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2016
Actual (reported)October 26, 2016
Actual (reported)May 25, 2017
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Duration of hospital stay
at day 0
Analgesia Type: general anesthesia versus sedation
at day 1
recurrent complications
at day 1
Operating Time
at day 1
Fertility prognosis by Mage score
at 3 months
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
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.
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.
Anne-Sophie GREMEAU
University Hospital, Clermont-Ferrand
First Submitted
October 10, 2016
First Posted
May 25, 2017
Study Start
October 26, 2016
Actual (reported)Primary Completion
December 2018
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
Henry-Suchet J, Soler A, Loffredo V. Laparoscopic treatment of tuboovarian abscesses. J Reprod Med. 1984 Aug;29(8):579-82. No abstract available.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 25, 2017
Record last verified: 2016-10
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