The rationale of opportunistic bilateral salpingectomies (OBS) during benign gynaecological and obstetric surgery: a consensus text of the Flemish Society of Obstetrics and Gynaecology (VVOG).

Ovarian cancer (OC), is a disease difficult to diagnose in an early stage implicating a poor prognosis. The 5-year overall survival in Belgium has not changed in the last 18 years and remains 44 %. There is no effective screening method (secondary prevention) to detect ovarian cancer at an early stage. Primary prevention of ovarian cancer came in the picture through the paradigm shift that the fallopian tube is often the origin of ovarian cancer and not the ovary itself. Opportunistic bilateral salpingectomy (OBS) during benign gynaecological and obstetric surgery might have the potential to reduce the risk of ovarian cancer by as much as 65 %. Bilateral risk-reducing salpingectomy during a benign procedure is feasible, safe, appears to have no impact on the ovarian function and seems to be cost effective. The key question is whether we should wait for a RCT or implement OBS directly in our daily practice. Guidelines regarding OBS within our societies are therefore urgently needed. Our recommendation is to inform all women without a child wish, undergoing a benign gynaecological or obstetrical surgical procedure about the pro's and the con's of OBS and advise a bilateral salpingectomy. Furthermore, there is an urgent need for a prospective registry of OBS. The present article is the consensus text of the Flemish Society of Obstetrics and Gynaecology (VVOG) regarding OBS.

Predicting response to neoadjuvant chemotherapy in patients with cervical carcinoma: can we do without any longer?

The aim of the study was to identify variables that may predict the response to neoadjuvant chemotherapy (NACT) in patients with cervical cancer as maturing data from the literature indicate that this therapeutic strategy might be beneficial to some but harmful to others. Clinico-pathologic variables including age, histology, tumor differentiation, as well as immunohistochemical overexpression of p53, mdm2, c-erbB-2, and cathepsin D in 37 of these patients were evaluated as possible predictors of response to the NACT. Fifty-five patients with stage IIB cervical cancer submitted to two courses of cisplatin/ifosfamide/mesna prior to definitive treatment with radical surgery or radiation therapy were the subjects of this study. The clinical response rate was 80% but none of the variables was able to predict response to NACT. Unless methods are found enabling us to predict response and therefore to identify those patients that could benefit from including NACT in the treatment of locally advanced cervical cancer, only women with primarily resectable tumors should be selected for this multimodality approach as a result of the possibility of cross-resistance with radiation therapy in nonresponders.

The prognostic significance of p53, mdm2, c-erbB-2, cathepsin D, and thrombocytosis in stage IB cervical cancer treated by primary radical hysterectomy.

The objective of this study was to evaluate the value of platelet count, p53, MDM2, c-erbB-2, and cathepsin D immunoreactivity as predictors of lymph node metastasis (LNM) as well as their prognostic significance in patients with stage IB cervical cancer treated by radical hysterectomy between 1991 through 1995. We also report on the outcome of a protocol considering lymph-vascular space invasion (LVSI) in addition to LNM as a strong motivation for adjuvant radiotherapy. A total of 93 patients were the subject of this retrospective study. The incidence of positive nodes was high (30.1%). Thrombocytosis (>/= 400.000/mm3) was present in 6.7% of patients. Positive immunostaining was found for p53 (50.6%), MDM2 (21.7%), c-erbB-2 (14.5%), and cathepsin D (45.8%), but none of them was able to predict LNM. Only thrombocytosis was associated with an unfavorable prognosis: a statistically significant association was shown with relapse-free and overall survival in an univariate analysis (P = 0.0431 and P = 0.0012, respectively) with a tendency to significance in multivariate analysis (P = 0.079 and P = 0.0882, respectively). We postulate that thrombocytosis in early stage cervical cancer could be a marker for subclinical tumor burden. LVSI, regarded as an indication for adjuvant radiotherapy, was no longer associated with poor relapse-free or overall survival, but resulted in a 41% postoperative irradiation rate. Further research is needed to establish the value of LVSI in postoperative radiotherapy decision making.

Systematic review of breast cancer related lymphoedema: making a balanced decision to perform an axillary clearance.

AIM: Breast cancer-related lymphoedema (BCRL) is a disabling complication developing after breast cancer treatment in a proportion of patients. Its impact on quality of life becomes more substantial as survival after breast cancer diagnosis increases. The incidence of BCRL following breast cancer treatment varies due to a lack of -uniform definition and measurement criteria. This review aims to determine the prevalence of BCRL following axillary lymph node dissection (ALND) as a benchmark to be used in a risk-benefit medical decision whether to proceed with ALND or not. The risk of leaving unresected non-sentinel metastatic lymph nodes with a presumed inherent risk of local recurrence will be balanced against the risk of BCRL following a potentially unnecessary ALND. METHODS: Pubmed and Embase databases were searched for all publications on BCRL in order to estimate its -incidence and to decide on the most appropriate measurement method to use in clinical practice. RESULTS: 51 articles were identified on BCRL incidence and measurement technique. Most studies measured BCRL based on differences in arm circumference (n = 18) or by self-reported symptoms (n = 18). The weighted average of BCRL incidence following ALND measured by self-report and circumference method was 28% and 16%, respectively. CONCLUSION: The importance of ALND and irradiation as part of the treatment of operable breast carcinoma is well established, but its morbidity is less well documented. We argue self-report as the most appropriate method to -establish a diagnosis of BCRL. Therefore a 28% risk of finding non-sentinel lymph node metastases in a completion ALND will be regarded as the cut-off in a medical decision to proceed with ALND.

Identification of neonatal near miss by systematic screening for metabolic acidosis at birth.

AIMS: To evaluate the relevance of systematic screening for neonatal metabolic acidosis at birth as part of perinatal audit. METHODS: For every baby, born in Ziekenhuis Oost Limburg, Genk Belgium between 1/1/2010 and 31/12/2010, cord blood was analysed to diagnose metabolic acidosis, defined as arterial or venous pH ≤ 7.05 or 7.17 respectively, in association with base excess of ≤ -10 mmol/L. Three observers identified indicators for suboptimal peripartal care with likely contribution to metabolic acidosis. In a multidisciplinary consensus meeting, these indicators were classified into 5 categories : (a) fetal monitoring error (b) labour management error, (c) instrumental vaginal delivery for fetal distress within 2 h of second stage, (d) non-obstetric medical complications, (e) preterm births or accidental cases at term. RESULTS: In a total of 2117 neonates, there were 11 intra-uterine, 1 intrapartum and 3 early neonatal deaths, bringing early perinatal mortality rate at 7.1‰. Metabolic acidosis was identified in 23 (1.1%) babies, of which 21 (91.3%) left hospital in good clinical condition. Two babies (0.9‰), born in category c, had chronic neurologic symptoms. DISCUSSION: Systematic screening for neonatal metabolic acidosis caused a 2.5-fold increase of case identifications eligible for perinatal audit and opened perspectives towards rationalised improvement of perinatal care, in addition to the information obtained from cases of perinatal mortality. Next to indicators of perinatal mortality, perinatal audit programs should include neonatal metabolic acidosis as an extra parameter for quality assessment of perinatal care. CONCLUSION: Adding cases of near-miss neonatal morbidity to perinatal mortalities in perinatal audit programs increases opportunities for improvement of perinatal care.

Outcome of per protocol best-evidence based routine breast cancer care in a large regional hospital in Belgium: the importance of a prospective database in quality assurance.

AIM: Criteria for future accreditation of breast cancer centres in Belgium will be mainly based on the case load per surgeon or per centre. We would like to argue that the prospective collection of relevant data and the analysis of treatment related outcome derived from these data is feasible and should be the ultimate criterion for quality assessment and thus for accreditation since outcome is a more direct measurement of quality. METHODS: Data were prospectively collected on 715 invasive non metastatic breast cancers between 2002 and 2007 treated according to standard, best-evidence protocols in the setting of a large district hospital. Univariate and multivariate survival analysis were performed and compared to national and international databases. RESULTS: 5 year disease-free survival (DFS) and overall survival (OS) in our series were respectively 77 and 84%. In the multivariate analysis of DFS, only her-2-neu status (her-2-neu positivity being associated with a poor prognosis) and age (older age being a worse prognostic factor) were statistically significant prognostic factors. For OS, her-2-neu, age, and positive nodes were statistically significant prognostic factors. The outcome is comparable to other data sets. CONCLUSION: Centres dedicated to the care of women with breast cancer have the moral duty to produce outcome based results of their treatment. This report shows that such a collection of data is feasible and can be imposed as a prerequisite for accreditation. We also argue that outcome based data of treatment are a more solid base for quality assurance than case load.

The construct of breast cancer risk perception: need for a better risk communication?

Breast cancer risk assessment and communication are much neglected aspects of women's health care. Breast cancer is the most prevalent cancer-related disease that touches the deepest of a women's feelings and the subject thus attracts much of the attention of the media. Disease prevalence and media coverage are the roots of inappropriate breast cancer risk perception. Many women overestimate their personal breast cancer risk. Inappropriate risk perception precedes inappropriate health behaviour and it is pivotal to understand the underlying mechanisms in order to plan intervention. Whether interventions such as patient education through counselling and objective risk assessment are effective in restoring inappropriate breast cancer risk perception remains a question unanswered, but the tools to measure breast cancer risk are available and were validated.

Recurrent Paget's disease of the vulva after simple vulvectomy and skin grafting. A case report.

A patient with recurrent Paget's disease of the vulva 11 years after simple vulvectomy and skin grafting is presented. This is the first report of an intra-epithelial vulvar Paget lesion with recurrence in a skin graft. The current hypotheses regarding the histogenesis of Paget's disease of the vulva are discussed.

Transabdominal ultrasonography of the bladder as a staging examination for cervical carcinoma.

OBJECTIVE: To determine the potential of transabdominal ultrasonography to demonstrate the presence or absence of bladder infiltration in patients with cervical carcinoma. DESIGN: A descriptive study. SETTING: The oncology unit in a tertiary medical centre serving a black rural and urban population. STUDY POPULATION: 110 consecutive unstaged patients with histologically proven cervical carcinoma. MAIN OUTCOME MEASUREMENTS: The findings-designated normal, suspicious or infiltration-on ultrasonography and cystoscopy. RESULTS: Transabdominal bladder ultrasonography in this study had a sensitivity of 100%, a specificity of 76,5%, a positive predictive value of 60,4% and a negative predictive value of 100% compared with cystoscopy in the evaluation of the bladder for infiltration by cervical carcinoma. CONCLUSION: Although not accepted as a staging procedure by the International Federation of Gynecology and Obstetrics, transabdominal bladder ultrasonography can be used as a triage for bladder infiltration by cervical carcinoma in a cost-effective way, referring only those patients with abnormal cystoscopic and biopsy findings.

Hysterectomy for septic abortion--is bilateral salpingo-oophorectomy necessary?

Ovarian conservation at the time of hysterectomy for complicated septic abortion is important in this young population group. In a retrospective study, the histological evaluation of the ovaries of 25 patients were compared with the macroscopic description in the operation reports. In 72.3% of the ovaries examined there was no infection. None of the ovaries described clinically as normal at laparotomy showed histological signs of infection. The clinical assessment of infected ovaries was false-positive in 40% of cases but there was no false-negative decision-making. It is concluded that ovaries which appear normal at hysterectomy for septic abortion should be conserved.

A properly conducted trial of a ventouse can prevent unexpected failure of instrumental delivery.

A retrospective study over a 5-year period reviewed 71 unexpected failures of instrumental delivery and compared them with a group of 21 trials of ventouse to identify causes for failure and their impact on neonatal outcome. There was a statistically significant difference between the two groups in terms of pre-application assessment of fetal size, maternal pelvis and palpable fetal head above the pelvic brim (P less than 0.00001). There was also a significant difference in neonatal morbidity (P less than 0.01). All 5 neonatal deaths occurred in the failure group and were associated with multiple instrumentation.

Is ward evacuation for uncomplicated incomplete abortion under systemic analgesia safe and effective? A randomised clinical trial.

OBJECTIVE: To compare evacuation under systemic analgesia (fentanyl and midazolam) in a treatment room (ward group) with evacuation under general anaesthesia in theatre. DESIGN: A prospective randomised clinical trial. SETTING: A tertiary medical centre serving a black urban population. SUBJECTS: One hundred and forty-two patients with uncomplicated incomplete abortions. INTERVENTION: Randomisation into two groups, those for evacuation under systemic analgesia and those for evacuation under general anaesthesia. MAIN OUTCOME MEASURES: Both groups were compared in terms of safety, efficacy, acceptability, blood consumption and time delay between admission and evacuation. RESULTS: Significantly less blood was used in the ward group (37 units for 13 patients) than in the theatre group (65 units for 24 patients) (P < 0.03). Significantly less time was taken between admission and evacuation in the ward group (median 7 hours 15 minutes) than in the theatre group (median 12 hours 38 minutes) (P < 0.0003). Evacuation under fentanyl and midazolam was safe, effective and acceptable for the majority of patients compared with evacuation under general anaesthesia. CONCLUSION: Patients with uncomplicated incomplete abortions (uterine size equivalent to a pregnancy of 14 weeks' duration or less) can undergo evacuation safely and effectively under fentanyl and midazolam and have a significantly smaller chance of requiring a blood transfusion.

Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester.

BACKGROUND: Misoprostol is being used increasingly in clinical practice for cervical ripening in first-trimester abortions, but because of lack of good evidence of its effectiveness, administration consensus has not been reached on dosage, route of administration, time of administration pre-operatively and gestational age group. In this study we tested the hypothesis that self-administration of 600 micrograms vaginal misoprostol is feasible and when used 2-4 hours pre-operatively results in sufficient cervical dilatation to make suction curettage easier. METHODS: A double-blind, randomised, placebo-controlled trial was undertaken. Two hundred and seventy-eight women scheduled for termination of pregnancy of up to 12 weeks' duration by manual vacuum aspiration were assigned to receive either 600 micrograms misoprostol pre-operatively, or placebo. The achievement of 'satisfactory' (> or = 7 mm) baseline cervical dilatation after 2-4 hours was evaluated as the primary outcome. Secondary outcome measurements included ease and duration of the procedure. Side-effects such as pre-operative bleeding, gastro-intestinal complaints and pain as well as adverse events were noted in all cases. FINDINGS: Self-administration of vaginal misoprostol was successful in all women and 273 women were evaluated for main end-points. A significantly larger proportion of patients in the treatment group reached cervical dilatation of > or = 7 mm (67.3% v. 30.9%, P < 0.0001). The side-effects were minimal and comparable in the two groups. In the treatment group the mean procedure duration was significantly shorter (220 seconds v. 321 seconds, P = 0.0013) and the procedure was more likely to be rated by the operator as 'easy' (81.8% v. 63.3%, P = 0.0082). This resulted in a significant reduction in treatment failure in the < 70-day gestation group (5.0% v. 14.7%, P = 0.005). CONCLUSION: It is feasible, safe and effective for 600 micrograms misoprostol to be self-administered vaginally 2-4 hours pre-operatively for cervical priming prior to manual vacuum aspiration. Further research is needed to establish optimal use in the first trimester and to determine patient acceptance.

Screening for cervical neoplasia in Mamelodi--lessons from an unscreened population.

AIM: To determine the prevalence of abnormal cervical cytological findings in an unscreened population; to assess patients' awareness of cervical cancer and the importance of early diagnosis; and to evaluate the accuracy of visual inspection of the cervix as a screening method for asymptomatic cervical cancer. STUDY STRUCTURE: Descriptive. SETTING: Mamelodi Hospital, a community day hospital east of Pretoria, serving a black urbanised population that had never been exposed to a routine cervical cytological screening programme. METHODS: One thousand and ninety-five women of reproductive age, who presented with a non-gynaecological complaint, were offered cervical cytological testing and were asked to complete a questionnaire. Visual appreciation of the cervical condition was noted and compared with the cytology report. RESULTS: The prevalence of abnormal cervical cytological findings (low- and high-grade squamous cervical intra-epithelial neoplasia (CIN), excluding human papillomavirus-induced cell changes only) was 54/1,000. Only 2% of the patients had a good knowledge of cervical cancer and cervical screening. Visual inspection of the cervix detected 4 out of 5 cervical cancers in this group, but failed to identify those patients with high-grade CIN. CONCLUSION: This study shows a high prevalence of abnormal cervical cytological findings in a population ignorant about cervical cancer. Recommendations on how to improve this situation are made.

Audit on nuchal translucency thickness measurements in Flanders, Belgium: a plea for methodological standardization.

OBJECTIVES: To audit nuchal translucency thickness (NT) measurements for fetal aneuploidy screening in Flanders, and to estimate the impact of small variations in NT measurement on the screening result of two first-trimester screening algorithms: maternal age + NT (Algorithm A), and maternal age + NT + pregnancy associated plasma protein-A + free beta-human chorionic gonadotropin (Algorithm B). METHODS: We used the database of first-trimester combined screening, as collected by the General Medical Laboratory AML in Antwerp, Belgium, between 1 January 2001 and 1 April 2004. Audit was performed by establishing a delta-NT distribution curve for one trainee of The Fetal Medicine Foundation (FMF) and for a group of 263 other sonographers, in comparison with the FMF reference values. Risks for fetal aneuploidy were calculated at a cut-off value of 1 : 300 for Algorithm A and 1 : 150 for Algorithm B. These risks were recalculated in both algorithms after a modeled increase of all NT values by 0.1 or 0.2 mm. RESULTS: In a total of 592 measurements performed by the FMF trainee, the 5th, 50th and 95th percentiles of delta-NT measurements were at -0.41, +0.03 and +0.68 mm, respectively. These values were close to the FMF reference values. The screen-positive rate for this set of data was 4.4% (26/592) in both algorithms. For the 12 555 measurements of the 263 other sonographers, the 5th, 50th and 95th percentiles of delta-NT were at -0.81, -0.14 and +0.73 mm, respectively, which clearly indicates underestimation of NT in the lower range. In this set of data the screen-positive rate was 3.5% for both algorithms (439/12 555 for Algorithm A and 436/12 555 for Algorithm B). Also in this group, 5% (59/1186) of negative screening results at maternal age > or = 35 years in Algorithm A became positive after a modeled 0.1-mm increase in NT, whereas this was only in 1.2% (134/11 369) of tests at maternal age < 35 years (P < 0.0001). The overall increase of screen-positive rate in Algorithm A after an NT modification of +0.1 mm was 1.2% (152/12 555), significantly more than in Algorithm B (86/12 555; 0.7%) (P < 0.0001). CONCLUSION: In Flanders, there is a systematic underestimation of NT in comparison with the FMF reference range. Attempts to change these measurements according to the FMF criteria are crucial. This will mainly influence the screening results of women at advanced maternal age and of NT-based algorithms without the use of other parameters.