Three-dimensional transvaginal sonographic assessment of uterine volume as preoperative predictor of need to morcellate in women undergoing laparoscopic hysterectomy.

OBJECTIVE: In light of recent statements from the United States Food and Drug Administration warning against the use of power morcellation of uterine leiomyomas during laparoscopy, we sought to evaluate the use of preoperative two- (2D) and three- (3D) dimensional transvaginal ultrasound (US) assessment of uterine volume to predict the need for morcellation in women undergoing laparoscopic hysterectomy (LH). METHODS: This was a prospective observational study performed between October 2008 and November 2011 in a tertiary referral laparoscopic unit. All women scheduled to undergo LH were included and underwent detailed preoperative transvaginal US. Uterine volumes were calculated using 2D-US measurements (ellipsoid formula), and using Virtual Organ Computer-aided AnaLysis (VOCAL™) having acquired 3D-US volumes of the uterus. Age, parity, need to morcellate and final uterine dry weight at histology were recorded. The estimated uterine volumes were then incorporated into a previously published logistic regression model to predict the need to morcellate for both nulliparous and parous women. The probability threshold cut-off of 0.14 (95% sensitivity) was evaluated in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (LRs). The performance of the models incorporating 2D- and 3D-US calculations were compared with 2D- and 3D-US-generated volumes alone, using receiver-operating characteristics (ROC) curves. RESULTS: Of 76 women who underwent LH during the study period, 79% (n = 60) had complete background and 3D-US data. Their mean age was 43.7 years, 91.7% were parous and 35% underwent morcellation. The greatest uterine volume that did not require morcellation was 404 mL estimated using 3D-US, which corresponded to a uterine volume of 688.8 mL using 2D-US. The smallest uterine volume that required morcellation was 118.9 mL using 3D-US, which corresponded to a uterine volume of 123.4 mL using 2D-US. The 3D-US uterine volume for parous women with a sensitivity of 95% based on ROC-curve analysis was approximately 120 mL, which equated to a predicted probability of morcellation cut-off of 0.14. For this cut-off, specificity was 55.00%, PPV was 51.35%, NPV was 95.65%, LR+ was 2.11 and LR- was 0.09. Areas under the ROC curves for the morcellation logistic regression model were 0.769 (95% CI, 0.653-0.886) and 0.586 (95% CI, 0.419-0.753) using uterine volumes obtained by 3D-US and by 2D-US, respectively, and they were 0.938 (95% CI, 0.879-0.996) and 0.815 (95% CI, 0.681-0.948) using 3D-US and 2D-US volumes alone. CONCLUSIONS: The need to morcellate can be predicted preoperatively using 3D-US uterine volumes obtained by transvaginal US with a fair degree of accuracy. Uteri with volumes smaller than 120 mL at 3D-US are very unlikely to require morcellation. The incorporation of 3D-US-estimated uterine volume into the previously published logistic regression model does not seem to confer any significant improvement when compared with 3D-US uterine volume alone to predict the need to morcellate in women undergoing total LH. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Office gel sonovaginography for the prediction of posterior deep infiltrating endometriosis: a multicenter prospective observational study.

OBJECTIVE: To use office gel sonovaginography (SVG) to predict posterior deep infiltrating endometriosis (DIE) in women undergoing laparoscopy. METHODS: This was a multicenter prospective observational study carried out between January 2009 and February 2013. All women were of reproductive age, had a history of chronic pelvic pain and underwent office gel SVG assessment for the prediction of posterior compartment DIE prior to laparoscopic endometriosis surgery. Gel SVG findings were compared with laparoscopic findings to determine the diagnostic accuracy of office gel SVG for the prediction of posterior compartment DIE. RESULTS: In total, 189 women underwent preoperative gel SVG and laparoscopy for endometriosis. At laparoscopy, 57 (30%) women had posterior DIE and 43 (23%) had rectosigmoid/anterior rectal DIE. For the prediction of rectosigmoid/anterior rectal (i.e. bowel) DIE, gel SVG had an accuracy of 92%, sensitivity of 88%, specificity of 93%, positive predictive value (PPV) of 79%, negative predictive value (NPV) of 97%, positive likelihood ratio (LR+) of 12.9 and negative likelihood ratio (LR-) of 0.12 (P = 3.98E-25); for posterior vaginal wall and rectovaginal septum (RVS) DIE, respectively, the accuracy was 95% and 95%, sensitivity was 18% and 18%, specificity was 99% and 100%, PPV was 67% and 100%, NPV was 95% and 95%, LR+ was 32.4 and infinity and LR- was 0.82 and 0.82 (P = 0.009 and P = 0.003). CONCLUSIONS: Office gel SVG appears to be an effective outpatient imaging technique for the prediction of bowel DIE, with a higher accuracy for the prediction of rectosigmoid compared with anterior rectal DIE. Although the sensitivity for vaginal and RVS DIE was limited, gel SVG had a high specificity and NPV for all forms of posterior DIE, indicating that a negative gel SVG examination is highly suggestive of the absence of DIE at laparoscopy.

The prediction of pouch of Douglas obliteration using offline analysis of the transvaginal ultrasound 'sliding sign' technique: inter- and intra-observer reproducibility.

STUDY QUESTION: What is the inter-/intra-observer agreement and diagnostic accuracy among gynaecological and non-gynaecological ultrasound specialists in the prediction of pouch of Douglas (POD) obliteration (secondary to endometriosis) at offline analysis of two-dimensional videos using the dynamic real-time transvaginal ultrasound (TVS) 'sliding sign' technique? SUMMARY ANSWER: The inter-/intra-observer agreement and diagnostic accuracy for the interpretation of the TVS 'sliding sign' in the prediction of POD obliteration was found to be very acceptable, ranging from substantial to almost perfect agreement for the observers who specialized in gynaecological ultrasound. WHAT IS KNOWN ALREADY: Women with POD obliteration at laparoscopy are at an increased risk of bowel endometriosis; therefore, the pre-operative diagnosis of POD obliteration is important in the surgical planning for these women. Previous studies have used TVS to predict POD obliteration prior to laparoscopy, with a sensitivity of 72-83% and specificity of 97-100%. However, there have not been any reproducibility studies performed to validate the use of TVS in the prediction of POD obliteration pre-operatively. STUDY DESIGN, SIZE, DURATION: This was a reproducibility study which involved the offline viewing of pre-recorded video sets of 30 women presenting with chronic pelvic pain, in order to determine POD obliteration using the TVS 'sliding sign' technique. The videos were selected on real-time representative quality/quantity; they were not obtained from sequential patients. There were a total of six observers, including four gynaecological ultrasound specialists and two fetal medicine specialists. The study was conducted over a period of 1 month (March 2012-April 2012). PARTICIPANTS/MATERIALS, SETTING, METHODS: The four gynaecological ultrasound observers performed daily gynaecological scanning, while the other two observers were primarily fetal medicine sonologists. Each sonologist viewed the TVS 'sliding sign' video in two anatomical locations (retro-cervix and posterior uterine fundus), i.e. 60 videos in total. The POD was deemed not obliterated, if 'sliding sign' was positive in both anatomical locations (i.e. anterior rectum/rectosigmoid glided smoothly across the retro-cervix/posterior fundus, respectively). If the 'sliding sign' was negative (i.e. anterior rectum/rectosigmoid did not glide smoothly over retro-cervix/posterior fundal region, respectively), the POD was deemed obliterated. Diagnostic accuracy and inter-observer agreement among the six sonologists was evaluated. The same sonologist was also asked to reanalyse the same videos, albeit in a different order, at least 7 days later to assess for intra-observer agreement. A separate analysis of the inter- and intra-observer correlation was also performed to determine the agreement among the four observers who specialized in gynaecological ultrasound. Cohen's κ coefficient <0 meant that there was poor agreement, 0.01-0.20 slight agreement, 0.21-0.40 fair agreement, 0.41-0.60 moderate agreement, 0.61-0.80 substantial agreement and 0.81-0.99 almost perfect agreement. MAIN RESULTS AND THE ROLE OF CHANCE: Agreement (Cohen's κ) between all six observers for the interpretation of the 'sliding sign' for both sets of videos in both regions (retro-cervix and fundus) ranged from 0.354 to 0.927 (fair agreement to almost perfect agreement) compared with 0.630-0.927 (substantial agreement to almost perfect agreement) when only the gynaecological sonologists were included. The overall multiple rater agreement for the interpretation of the 'sliding sign' for both video sets and both regions was Fleiss' κ 0.454 (P-value <0.01) for all six observers and 0.646 (P-value <0.01) for the four gynaecological ultrasound specialists. The multiple rater agreement for all six or all four observers was higher for the retro-cervical region versus the fundal region (Fleiss' κ 0.542 versus 0.370 and 0.732 versus 0.560, respectively). The intra-observer agreement among the six observers for the interpretation of the 'sliding sign' and prediction of POD obliteration ranged from Cohen's κ 0.60-0.95 and 0.46-1.0 (P-value <0.01), respectively. After excluding the fetal medicine specialists, the intra-observer agreement for the interpretation of the 'sliding sign' and the prediction of POD obliteration ranged from Cohen's κ 0.71-0.95 and 0.67-1.0, respectively, indicating substantial to almost perfect agreement. When comparing the four gynaecological observers for the prediction of POD obliteration using the TVS 'sliding sign' (after excluding cases with the POD outcome classified as 'unsure' by the observers), the results for accuracy, sensitivity, specificity, positive and negative predictive value were 93.1-100, 92.9-100, 90.9-100, 77.8-100 and 97.7-100%, respectively. LIMITATIONS, REASONS FOR CAUTION: The 'gold standard' for the diagnosis of POD obliteration is laparoscopy; however, laparoscopic data were available only for 24 out of 30 (80%) TVS 'sliding sign' cases included in this study. Although this should not affect the inter- and intra-observer agreement findings, the ability to draw conclusions regarding the diagnostic accuracy of the TVS 'sliding sign' in the prediction of POD obliteration is somewhat limited. In addition, the diagnostic accuracy findings should be interpreted with the caveat that the cases classified as 'unsure' for the prediction of POD obliteration were excluded from the analysis. WIDER IMPLICATIONS OF THE FINDINGS: We have validated the dynamic real-time TVS 'sliding sign' technique for the prediction of POD obliteration, and this simple ultrasound-based test appears to have very acceptable inter-/intra-observer agreement for those who are experienced in gynaecological ultrasound. Given that women with POD obliteration at laparoscopy have an increased risk of bowel endometriosis and requirement for bowel surgery, the TVS 'sliding sign' test should be considered in the pre-operative imaging work-up for all women with suspected endometriosis, to allow for appropriate surgical planning. We believe the TVS 'sliding sign' technique may be easily learned by sonologists/sonographers who are familiar with performing gynaecological ultrasound, and that further studies are required to confirm the diagnostic accuracy of this new ultrasound technique amongst sonologists/sonographers with various levels of experience. STUDY FUNDING/COMPETING INTEREST(S): This study received no specific grant from any funding agency in the public, commercial or not-for-profit sectors and the authors declare no competing interests.

Prediction of pouch of Douglas obliteration in women with suspected endometriosis using a new real-time dynamic transvaginal ultrasound technique: the sliding sign.

OBJECTIVE: To evaluate preoperative real-time dynamic transvaginal sonography (TVS) in the prediction of pouch of Douglas (POD) obliteration in women undergoing laparoscopy for suspected endometriosis. METHODS: This was a multicenter prospective observational study undertaken from January 2009 to November 2011. All women with symptoms suggestive of endometriosis who were scheduled for laparoscopy underwent detailed preoperative TVS, in particular to ascertain whether the POD was obliterated. POD obliteration was assessed using a real-time TVS technique called the 'sliding sign'. Preoperative TVS sliding sign findings were then compared to gold standard laparoscopic POD findings. RESULTS: One hundred consecutive women with preoperative TVS and laparoscopic outcomes were included in the final analysis. Mean age was 32.8 years and mean age at diagnosis of endometriosis was 27.4 years. At laparoscopy, 84/100 (84%) were found to have some form of endometriosis (73% peritoneal endometriosis, 35% ovarian endometrioma(s), 33% deep infiltrating endometriosis). At laparoscopy, 30/100 (30%) had an obliterated POD and 19/30 (63.3%) of these women also had evidence of bowel endometriosis. The sonographic sliding sign technique had an accuracy of 93.0%, sensitivity of 83.3%, specificity of 97.1%, positive predictive value of 92.6%, negative predictive value of 93.2%, positive likelihood ratio of 29.2 and negative likelihood ratio of 0.17 in the prediction of POD obliteration (P = 1.8E-16). CONCLUSIONS: Preoperative real-time dynamic TVS evaluation using the sliding sign seems to establish with a high degree of certainty whether the POD is obliterated. Given the increased risk of deep infiltrating endometriosis in women with POD obliteration, the TVS sliding sign technique may also be useful in the identification of women who may be at a higher risk for bowel endometriosis.

The K-P algorithm: a new first-trimester growth model - comparison with other formulae and correlations with recorded embryonic lengths.

OBJECTIVE: To generate and validate individually fitted first-trimester growth curves using a new growth model. Secondary aims were to compare this new model with actual recorded embryonic measurements and validate its predictive accuracy. METHODS: A prospective study of women presenting to the Early Pregnancy Unit in the first trimester. Women with viable singleton pregnancies at the end of the first trimester who had had at least two crown-rump length (CRL) measurements were selected. An individual power function of CRL was derived from serial CRL measurements. Individual curves were fitted using computer software to estimate a dating adjustment factor ('k'), and a growth coefficient ('P') for each case. The predictive accuracy of the growth curves was then tested in a validation subset of the population that had a third CRL measurement. The population average curve from the developed model was also extrapolated to day 27 menstrual age (Carnegie stage 6), day 30 menstrual age (Carnegie stage 7) and day 84 menstrual age, and values were compared to previously reported measurements. RESULTS: 326 viable pregnancies were selected for CRL growth curve development. The mean time interval between CRL measurements was 20.5 days (range 2-44). The mean value for 'P' was 2.058, and for 'k' 24.6. Testing the model on a subset of 81 cases showed that the average error in predicting a third CRL measurement was 1% (SD 9.1%). CONCLUSIONS: These new, individually fitted growth curves for the first trimester correlate more closely with the recorded embryonic lengths than other standards.

Expectant management of spontaneous first-trimester miscarriage: prospective validation of the '2-week rule'.

OBJECTIVES: To assess uptake and success of expectant management of first-trimester miscarriage for a finite 14-day period, in order to evaluate our '2-week rule' of management. METHODS: This was a prospective observational study evaluating our proposed 2-week rule of expectant management, which is based on the finding that women managed expectantly are most likely to miscarry in the first 14 days and that to wait longer than 2 weeks without intervention does not confer a greater chance of successful resolution. Eligible women diagnosed with first-trimester miscarriage were offered a choice of expectant management or surgical evacuation under general anesthesia. Inclusion criteria for expectant management were: diagnosis of incomplete miscarriage (heterogeneous tissue, with or without a gestational sac, seen on ultrasound in the uterine cavity and distorting the endometrial midline echo), missed miscarriage (crown-rump length (CRL) >or= 6 mm with absent fetal heart activity) or empty sac (anembryonic pregnancy) based on transvaginal ultrasonography. Women with complete miscarriage, missed miscarriage at the nuchal translucency scan, molar pregnancy or miscarriage >or= 3 weeks in duration (missed miscarriage in which the CRL was >or= 3 weeks smaller than the gestational age based on last menstrual period), or with signs of infection or hemodynamic instability were excluded. Expectant management consisted of weekly ultrasonography for 2 weeks. If after 2 weeks resolution was not complete, surgery was advised. RESULTS: 1062 consecutive pregnant women underwent transvaginal ultrasound examination. Of these, 38.6% (410/1062) were diagnosed with miscarriage, of whom 241 (59%) were symptomatic at the time of presentation and 282 were eligible for the study. These were offered expectant management and 80% (227/282) took up this option. 11% (24/227) were lost to follow-up; therefore, complete data were available on 203 women. Overall spontaneous resolution of miscarriage at 2 weeks was observed in 61% (124/203) of women. Rates of spontaneous resolution at 2 weeks according to the type of miscarriage were 71% for incomplete miscarriage, 53% for empty sac and 35% for missed miscarriage. The incidence of unplanned emergency dilatation and curettage due to gynecological infection or hemorrhage was 2.5% (5/203). CONCLUSIONS: Expectant management based on the 2-week rule is a viable and safe option for women with first-trimester miscarriage. Women with an incomplete miscarriage are apparently the most suitable for expectant management.