Should we centralise care for the patient suspected of having ovarian malignancy?

OBJECTIVES: Outcome of ovarian cancer is better when surgery is provided by a gynaecological oncologist than by a general gynaecologist. However, when all patients with an adnexal mass have to be operated by gynaecological oncologists, this requires a change in the organisation of care, which generates additional costs. In this study, we assess the costs and effects of centralised and regular care for women with an ovarian malignancy in the Netherlands. METHODS: We performed a cost-effectiveness analysis. We considered three strategies. In the first strategy, patients were operated by a general gynaecologist (general care strategy). In the second strategy, patients were operated by a gynaecological oncologist (specialised care strategy). In the third strategy, evaluation of the adnexal mass took place prior to surgery by means of the Risk of Malignancy Index (diagnostic strategy). Patients at high risk for malignancy were supposed to be operated in a specialised care setting, whereas low risk patients were supposed to be operated in a general care setting. For each strategy we calculated life expectancy and incremental costs per life year gained (LYG). RESULTS: Mean life expectancy of a patient with an ovarian malignancy in the general strategy was 2.7 years, in the diagnostic strategy 3.0 years and in the specialised strategy 3.1 years. The incremental costs to gain one additional life year with specialised surgery as compared to the diagnostic strategy were € 61,871 per LYG. CONCLUSION: In women with an adnexal mass, a diagnostic strategy prior to the decision for surgery by a general gynaecologist or a gynaecological oncologist provides the best balance between costs and effects.

Patients' preferences in mode of surgery of an adnexal mass.

OBJECTIVE: We assessed the preferences of women with an adnexal mass for the mode of surgery. METHODS: A structured interview was designed in which women, scheduled for surgery for an adnexal mass, were confronted with fictive scenarios of the different approaches. Women were asked at what probability of a false negative test result of frozen section diagnosis they would prefer frozen section diagnosis over primary radical surgery. Furthermore, the women were asked at what probability of ovarian malignancy they would prefer laparoscopy over laparotomy. RESULTS: We interviewed 43 women. When the probability of frozen section diagnosis being false negative was set at 90%, 97% of the women preferred primary radical surgery. The mean threshold at which women switched their preference from primary radical surgery to frozen section diagnosis was at a risk of 49% on a false negative test result of frozen section diagnosis. In the choice between laparoscopy over laparotomy, the mean threshold at which the women switched their preference from laparoscopy to laparotomy was at a risk of 55% on ovarian malignancy. CONCLUSION: Women scheduled for surgery of an adnexal mass at low risk of ovarian malignancy, prefer frozen section diagnosis over primary radical surgery and prefer laparoscopy over laparotomy.

The accuracy of risk scores in predicting ovarian malignancy: a systematic review.

OBJECTIVE: To perform a systematic review of the literature on the accuracy of prediction models in the preoperative assessment of adnexal masses. DATA SOURCES: Studies were identified through the MEDLINE and EMBASE databases from inception to March 2008. The MEDLINE search was performed using the keywords ["ovarian neoplasms"[MeSH] NOT "therapeutics"[MeSH] AND "model"] and ["ovarian neoplasms"[MeSH] NOT "therapeutics"[MeSH] AND "prediction"]. The Embase search was performed using the keywords [ovary tumor AND prediction], [ovary tumor AND Mathematical model], and [ovary tumor AND statistical model]. METHODS OF STUDY SELECTION: The search detected 1,161 publications; from the cross-references, another 116 studies were identified. Language restrictions were not applied. Eligible studies contained data on the accuracy of models predicting the risk of malignancy in ovarian masses. Models were required to combine at least two parameters. TABULATION, INTEGRATION, AND RESULTS: Two independent reviewers selected studies and extracted study characteristics, study quality, and test accuracy. There were 109 accuracy studies that met the selection criteria. Accuracy data were used to form two-by-two contingency tables of the results of the risk score compared with definitive histology. We used bivariate meta-analysis to estimate pooled sensitivities and specificities and to fit summary receiver operating characteristic curves.Studies included in our analysis reported on 83 different prediction models. The model developed by Sassone was the most evaluated prediction model. All models has acceptable sensitivity and specificity. However, the Risk of Malignancy Index I and the Risk of Malignancy Index II, which use the product of the serum CA 125 level, an ultrasound scan result, and the menopausal state, were the best predictors. When 200 was used as the cutoff level, the pooled estimate for sensitivity was 78% for a specificity of 87%. CONCLUSION: Based on our review, the Risk of Malignancy Index should be the prediction model of choice in the preoperative assessment of the adnexal mass.

Women's preference for laparoscopic or abdominal hysterectomy.

In the present study, women's preferences on advantages and disadvantages of laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) have been studied. Patients' preferences were evaluated in individual, structured interviews in women scheduled for hysterectomy and questionnaires in nurses. Forty-three patients and 39 nurses were included. After general information, 84% of patients and 74% of nurses preferred LH over AH. This preference did not change after supplying more detailed information or after hysterectomy. The avoidance of complications was indicated as the most important factor in the decision. More than half of the women evaluated a difference of 1% as the maximum acceptable risk of major complications. When confronted with scenarios based on current evidence, both patients and nurses prefer LH over AH. This study supports further implementation of LH in clinical practice. The actual major complication rate in hysterectomy, however, is perceived as high.

Pelvic organ function in randomized patients undergoing laparoscopic or abdominal hysterectomy.

STUDY OBJECTIVE: To assess the incidence of urinary incontinence, bowel dysfunction, and sexual problems after laparoscopic hysterectomy as compared with abdominal hysterectomy. DESIGN: Randomized controlled trial (Canadian Task Force classification I). SETTING: Single-center teaching hospital in the Netherlands, experienced in gynecologic minimal access surgery. PATIENTS: Women with a benign or malignant condition scheduled for hysterectomy where vaginal hysterectomy was not feasible and laparoscopic hysterectomy was possible. INTERVENTIONS: Laparoscopic (n = 38) and abdominal hysterectomy (n = 38). MEASUREMENTS AND MAIN RESULTS: Patients were asked before and 3 months after surgery whether they experienced urinary incontinence and completed the validated questionnaires Urogenital Distress Inventory, Incontinence Impact Questionnaire, Defecatory Distress Inventory, and the Questionnaire for screening Sexual Dysfunctions 1 year after surgery. The incidence of urinary incontinence at 3 months after surgery decreased equally in both groups as compared with baseline. De novo urinary incontinence and sexual problems were rare. One year after surgery, a significant treatment effect favoring laparoscopic hysterectomy was found in the Urogenital Distress Inventory and Incontinence Impact Questionnaire, whereas no differences were found in the Defecatory Distress Inventory and Questionnaire for screening Sexual Dysfunctions. CONCLUSION: Laparoscopic hysterectomy is superior to abdominal hysterectomy with respect to postoperative symptoms of urinary dysfunction.

Is three-dimensional ultrasonography of additional value in the assessment of adnexal masses?

OBJECTIVE: Patient characteristics, CA125 level and two-dimensional (2D) ultrasonography can be used to predict the probability of malignancy of an ovarian mass. Three-dimensional (3D) ultrasonography might also contribute to the prediction of malignancy. We evaluated whether addition of 3D features to a diagnostic model could improve the discriminative capacity of the model. METHODS: This multicenter prospective study was approved by the institutional review board. Women with an adnexal mass scheduled for surgery underwent 2D and 3D ultrasonographic examination in the week prior to surgery. Stepwise logistic regression was used to construct two models for the prediction of malignancy: a model based on patient characteristics, level of CA125 and 2D ultrasonography and a second model based on patient characteristics, level of CA125, 2D and 3D ultrasonography. Receiver operator characteristic (ROC) curve analysis was used to compare the capacity of the two models to discriminate between benign and malignant adnexal masses. RESULTS: We included 181 women with an adnexal mass, of which144 were benign and 37 showed malignancy on histopathology. The 3D model discriminated better between benign and malignant adnexal masses than the 2D model (areas under the ROC curve of 0.92 and 0.82, respectively, p=0.02). The calibration of both models was good. CONCLUSION: In the assessment of the ovarian mass, the use of 3D ultrasonography significantly improves the prediction of malignancy as compared to patient characteristics and 2D ultrasonography.

Quality of life and surgical outcome after total laparoscopic hysterectomy versus total abdominal hysterectomy for benign disease: a randomized, controlled trial.

STUDY OBJECTIVE: Minimally invasive surgery aims to achieve at least a similar clinical effectiveness with a quicker recovery than traditional open techniques. Although there have been numerous randomized clinical trials comparing laparoscopic hysterectomy with hysterectomy by laparotomy, only a few studies have compared quality of life after different types of hysterectomy. None of these studies evaluated total laparoscopic hysterectomy. In this paper, we report on a randomized comparison of quality of life after total laparoscopic versus total abdominal hysterectomy. DESIGN: Randomized, controlled trial (Canadian Task Force classification I). SETTING: Single-center teaching hospital in The Netherlands. PATIENTS: Patients scheduled for hysterectomy for a benign condition, in whom a vaginal hysterectomy was not possible and laparoscopic hysterectomy was feasible (mobile uterus not exceeding the size of 18 weeks' gestation). INTERVENTIONS: Abdominal versus laparoscopic hysterectomy. MEASUREMENTS AND MAIN RESULTS: Patients completed the Dutch version RAND-36 health survey preoperatively as well as at 5 time points in the first 12 weeks after surgery. The primary outcome of the study was quality of life as measured by the RAND-36. A linear mixed model was used for statistical analysis while accounting for baseline values. Secondary outcomes were hospital stay and complications. There were 88 patients eligible, of whom 59 gave consent for randomization. Twenty-seven women were allocated to the laparoscopic arm and 32 to the abdominal arm. We found a significant treatment effect favoring laparoscopic hysterectomy in the RAND-36 scale for vitality. Laparoscopic hysterectomy performed better on all other scales of the RAND-36, but these differences were not statistically significant. CONCLUSIONS: Laparoscopic hysterectomy results in more postoperative vitality when compared with abdominal hysterectomy. For this reason, all women with a benign condition requiring abdominal hysterectomy, in whom the laparoscopic approach is feasible, should have the chance to choose laparoscopic hysterectomy.

Evaluation of adnexal masses with three-dimensional ultrasonography.

OBJECTIVE: To estimate whether three-dimensional ultrasonography and three-dimensional power Doppler investigation can contribute to the differentiation between benign and malignant ovarian masses. METHODS: Women scheduled for surgical treatment of an adnexal mass were included in a multicenter prospective study. All women underwent two-dimensional and three-dimensional ultrasonographic examination in the week before surgery. All parameters were compared in women with benign tumors, borderline tumors, and malignant tumors using receiver operating characteristic analysis and likelihood ratios. RESULTS: We included 181 women; 144 had a benign mass, 26 had a malignancy, and 11 had a borderline tumor. At three-dimensional ultrasonography, the most striking difference was found in the presence of central vessels in an adnexal mass. Central vessels assessed by three-dimensional ultrasonography were present in 15% (21 of 144) of the benign masses, 69% (18 of 26) of the malignant masses, and 27% (3 of 11) of the masses of borderline malignancy. The likelihood ratios for presence of central vessels for a mass being malignant and/or borderline was 4.9 (95% confidence interval 2.1-12). Mean gray index and flow index were also significantly different between the groups, but other features were not. CONCLUSION: The central localization of vessels in an adnexal mass, as observed by three-dimensional ultrasonography, the mean gray index, and the flow index are potentially important parameters for distinguishing benign from malignant adnexal masses. LEVEL OF EVIDENCE: II-2.

The impact of size of the adnexal mass on the accuracy of frozen section diagnosis.

OBJECTIVE: We recently showed that frozen section diagnosis has an almost perfect specificity for the diagnosis of malignancy in an adnexal mass, whereas the sensitivity was, though good, not perfect. The aim of the present study was to examine whether the accuracy of frozen section diagnosis is affected by the size of the adnexal masses. METHODS: We included women that underwent frozen section diagnosis for adnexal mass surgery. For each patient we recorded serum CA125 level, menopausal status, tumour size, and histologic classification both at frozen section diagnosis and at definite histological examination. We calculated sensitivity and specificity of frozen section diagnoses, both in tumours below and above 10 cm diameter. RESULTS: We included 257 patients, of whom 142 had a benign tumour, 28 had a borderline tumour and 87 had a malignant tumour at definitive histological assessment. In case frozen section diagnosis showed malignancy, this was always confirmed at final histological assessment. In women with a tumour <10 cm, there was only 1 false negative diagnosis in 50 women with a benign frozen section diagnosis, whereas there were 11 false negative diagnoses in 97 women in women with a tumour > or = 10 cm. The corresponding likelihood ratios of a benign diagnosis for presence of malignancy were .15 for tumours > or = 10 cm and 0.03 for tumours <10 cm, respectively. CONCLUSION: The accuracy of frozen section diagnosis is dependent on tumour size. In adnexal masses > or = 10 cm, a benign result of the frozen section diagnosis is less reliable than in women with a tumour <10 in cm.