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1.
Hum Reprod ; 29(6): 1189-98, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24664128

ABSTRACT

STUDY QUESTION: In the use of 'tenderness-guided' transvaginal ultrasound, is the diagnostic accuracy of three-dimensional (3D) ultrasonography better than two-dimensional (2D) ultrasonography in the identification of deep endometriosis? SUMMARY ANSWER: Three-dimensional ultrasonography has a significantly higher diagnostic accuracy in the diagnosis of posterior locations of deep endometriosis without intestinal involvement, such as the uterosacral ligaments, vaginal and rectovaginal endometriosis. WHAT IS KNOWN ALREADY: The only previous study of the diagnosis of posterior compartment endometriosis reported an poor sensitivity of 3D ultrasonography for uterosacral and sigmoid colon involvement. STUDY DESIGN, SIZE, DURATION: This diagnostic test study included 202 patients scheduled for surgery because of clinical suspicion of deep pelvic endometriosis and was carried out between January 2009 and September 2012. PARTICIPANTS/MATERIALS, SETTING, METHODS: Modified transvaginal ultrasonography was performed on all of the women by a single examiner. Two locations of deep endometriosis were considered: intestinal involvement and other posterior lesions (including vaginal location, rectovaginal septum and uterosacral ligaments). Once the 2D ultrasonography had been performed, the 3D acquisition was performed and the obtained volume was stored. To avoid the risk of recall bias, the same operator evaluated the 3D volumes 6 months after the last examination using virtual navigation to provide a presumptive diagnosis of the presence and localization of deep endometriosis. In addition, to evaluate the reproducibility of 3D, two operators with different levels of expertise performed a retrospective review of 3D volumes from a random sample of 35 patients, twice, 1 week apart to also assess intraobserver agreement. The diagnostic performance of both tests was expressed as area under the receiver-operating characteristics curve (AUC), sensitivity, specificity, positive and negative predictive values, positive (LR+) and negative (LR-) likelihood ratios, with their respective 95% confidence interval (CI). Reproducibility was evaluated using kappa statistics. MAIN RESULTS AND THE ROLE OF CHANCE: Surgery revealed deep endometriosis in 129 patients. The AUCs for endometriosis of intestinal location were similar for both ultrasound techniques. The AUCs for endometriosis of other posterior locations were significantly different (0.891, 95% CI 0.839-0.943 for 3D versus 0.789, 95% CI 0.720-0.858 for 2D; P = 0.0193). For the intestinal involvement, the specificity, sensitivity, positive and negative predictive value, and LR+ and LR- were 93% (89-95%), 95% (88-98%), 89% (83-92%), 97% (93-99%), 13, and 0.06, respectively, for 2D ultrasound and 97% (93-99%), 91% (84-94%), 95% (88-98%), 95% (91-96%), 25, and 0.09, respectively, for 3D ultrasound. For other posterior locations, the specificity, sensitivity, positive and negative predictive value, and LR+ and LR- were 88% (82-93%), 71% (64-77%), 83% (75-90%), 79% (74-83%), 6.10, 0.32, respectively, for 2D ultrasound and 94% (89-97%), 87% (81-91%), 92% (86-96%), 90% (85-93%), 14.0, 0.14, respectively, for 3D ultrasound. Intraobserver agreement was substantial for both examiners (kappa 0.8754, for operator A and 0.7087, for operator B, respectively). Interobserver agreement was also substantial. LIMITATIONS, REASONS FOR CAUTION: The disadvantages of 3D ultrasound to be considered are the necessity of newer ultrasonographic equipment and that fewer sonographers completely know the 3D technique. There are also some limitations within this study. First, an expert examiner performed the real-time ultrasound and 3D volume acquisitions. Second, the same operator also performed the 3D evaluations but at least 6 months after the last acquisition to avoid a possible recall bias. WIDER IMPLICATIONS OF THE FINDINGS: The diagnostic performance obtained in the present study is superior to the accuracy reported in other studies of 3D ultrasonography, but not superior to all other published articles of 2D ultrasonography. The reported high diagnostic accuracy of 3D ultrasound could be widely generalizable because good reproducibility was demonstrated even with an operator with less expertise. STUDY FUNDING/COMPETING INTEREST(S): This study was supported in part by the Regione Autonoma della Sardegna (project code CPR-24750).


Subject(s)
Endometriosis/diagnostic imaging , Intestinal Diseases/diagnostic imaging , Ultrasonography/methods , Adolescent , Adult , Female , Humans , Middle Aged , Prospective Studies , Retrospective Studies , Sensitivity and Specificity , Young Adult
2.
Expert Opin Drug Metab Toxicol ; 8(7): 901-8, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22681335

ABSTRACT

INTRODUCTION: Progesterone (P), and its receptors (PRs), play a key role in uterine leiomyoma growth. Selective progesterone receptor modulators exert mixed antagonist and agonist effects on the PRs. Mifepristone, a PR-antagonist, reduces leiomyoma volume and related symptoms. Ulipristal acetate (UPA) exerts a potent antiprogestin activity, with less antiglucocorticoid activity compared to mifepristone. This property provides potential advantages for long-term use. AREAS COVERED: This paper focuses on the effect of UPA on leiomyoma's growth and related symptoms in women. The authors also evaluate UPA's efficacy in reducing leiomyoma's size and menorrhagia in Phase II/III trials. EXPERT OPINION: In the authors' opinion, UPA (5 mg/day) over 3 months can be used to plan the surgery in women with symptomatic leiomyomas. The tolerability and the safety of treatment over a period longer than 3 months have to be evaluated. The results of the follow-up treatment suggest that further studies could successfully evaluate the efficacy and the tolerability of intermittent 3-month courses of treatment.


Subject(s)
Drug Evaluation, Preclinical/methods , Leiomyoma/drug therapy , Norpregnadienes/pharmacology , Norpregnadienes/pharmacokinetics , Uterine Neoplasms/drug therapy , Adult , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Female , Hormone Antagonists/therapeutic use , Humans , Leiomyoma/surgery , Menorrhagia/drug therapy , Mifepristone/therapeutic use , Progesterone/metabolism , Receptors, Progesterone/antagonists & inhibitors , Receptors, Progesterone/metabolism , Uterine Neoplasms/surgery
3.
J Ultrasound Med ; 23(9): 1193-200, 2004 Sep.
Article in English | MEDLINE | ID: mdl-15328434

ABSTRACT

OBJECTIVE: The aim of this prospective study was to investigate the accuracy of B-mode transvaginal sonography alone and combined with color Doppler imaging and cancer antigen 125 (CA 125) plasma concentrations in differentiating peritoneal cysts from other adnexal masses. METHODS: Between September 1999 and September 2003, 213 adnexal masses underwent transvaginal sonography combined with power Doppler evaluation. Plasma concentrations of CA 125 were measured before surgery. The sonographic suspicion of peritoneal cysts (the presence of a bizarre lump-shaped cyst with a thin wall and fine internal septations with or without an ovary suspended among adhesions) was then compared with the surgical diagnosis. The overall agreement between the sonographic test results and the surgical findings was calculated by the kappa index. The diagnostic value of each test was also evaluated with likelihood ratios (LRs). RESULTS: Thirteen of 213 patients were found to have peritoneal cysts. Specificity and sensitivity of B-mode sonography for differentiating peritoneal cysts from other adnexal masses were 96% (95% confidence interval, 94%-97%) and 62% (95% confidence interval, 35%-83%), respectively. The value of the negative LR (0.40) indicated a good clinical test, whereas the positive LR (15) indicated an excellent test. Power Doppler imaging did not seem to increase the accuracy of B-mode transvaginal sonography (kappa = 0.51 and 0.52, respectively), nor did the association of CA 125 plasma concentration (kappa = 0.34). CONCLUSIONS: Transvaginal sonography alone is a useful method for detection of peritoneal cysts.


Subject(s)
Cysts/diagnostic imaging , Peritoneal Diseases/diagnostic imaging , Vagina/diagnostic imaging , Adnexal Diseases/diagnostic imaging , Adolescent , Adult , Aged , Aged, 80 and over , CA-125 Antigen/blood , Diagnosis, Differential , Female , Humans , Middle Aged , Prospective Studies , Sensitivity and Specificity , Ultrasonography, Doppler, Color
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