Drainage of Tubo - Ovarian Abscess: DTOA

Tubo-ovarian Abscess Clinical Trial

— DTOA  

Official title:

Comparative Effectiveness Clinical Early of Transvaginal and Laparoscopic Approaches for Drainage of Tubo -Ovarian Abscess. Randomized Noninferiority

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03166982
• Other study ID #: CHU-0283
• Secondary ID: 2016-A00961-50
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2016
• Last updated: May 23, 2017
• Start date: October 26, 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 15 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Tubo-ovarian Abscess

Intervention

Procedure:
• transvaginal approach

• laparoscopic approach

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (14)

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. — View 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. — View 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. Review. French. — View Citation

Gerber B, Krause A. A study of second-look laparoscopy after acute salpingitis. Arch Gynecol Obstet. 1996;258(4):193-200. — View 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. — View 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. Review. — View 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. Epub 2002 Oct 26. — View Citation

Henry-Suchet J, Soler A, Loffredo V. Laparoscopic treatment of tuboovarian abscesses. J Reprod Med. 1984 Aug;29(8):579-82. — View Citation

Le Bouëdec 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. — View 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. — View 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. — View Citation

Raiga J, Canis M, Le Bouëdec 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. — View 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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Clinical improvement	apyrexia to 72 hours and 1 month and EVA to 72 hours and 1 month	at 72 hours and at 1 month
Primary	Organic improvement	CRP Standards and GB to 72 hours and 1 month if initially high	at 72 hours and at 1 month
Secondary	Duration of hospital stay		at day 0
Secondary	Analgesia Type: general anesthesia versus sedation		at day 1
Secondary	recurrent complications	Per Statement of complications and postoperative and rehospitalization	at day 1
Secondary	Operating Time		at day 1
Secondary	Fertility prognosis by Mage score		at 3 months
Secondary	prognosis of chronic pelvic pain score by adhesions at second look laparoscopy		at 3 months