Health-related quality of life after interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with stage III ovarian cancer.

INTRODUCTION: The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improves recurrence-free (RFS) and overall survival (OS) in patients with FIGO stage III ovarian cancer. We evaluated the effect of HIPEC on patient's health-related quality of life (HRQoL) in the OVHIPEC trial. MATERIALS AND METHODS: OVHIPEC was a multicentre, open-label, randomized phase III trial for patients with stage III ovarian cancer. Patients were randomly assigned (1:1) to receive interval CRS with or without HIPEC with cisplatin. HRQoL was assessed using the EORTC QLQ-C30, and the ovarian (QLQ-OV28) and colorectal cancer (QLQ-CR38) modules. HRQoL questionnaires were administered at baseline, after surgery, after end of treatment, and every three months thereafter. HRQoL was a secondary endpoint, with the prespecified focus on the QLQ-C30 summary score and symptom scores on fatigue, neuropathy and gastro-intestinal symptoms. HRQoL was analysed using linear and non-linear mixed effect models. RESULTS: In total, 245 patients were randomized. One-hundred-ninety-seven patients (80%) completed at least one questionnaire. No significant difference over time in the QLQ-C30 summary scores was observed between the study arms (p-values for linear and non-linear growth: p > 0.133). The pattern over time for fatigue, neuropathy and gastro-intestinal symptoms did not significantly differ between treatment arms. CONCLUSION: The addition of HIPEC to interval CRS does not negatively impact HRQoL in patients with stage III ovarian cancer who are treated with interval CRS due to the extent of disease. These HRQoL results, together with the improvement in RFS and OS, support the viability of HIPEC as an important treatment option in this patient population. CLINICALTRIALS. GOV NUMBER: NCT00426257. EUDRACT NUMBER: 2006-003466-34.

Echogenicity of puborectalis muscle, cervix and vastus lateralis muscle in pregnancy in relation to mode of delivery.

OBJECTIVES: To confirm our previous observation that levator hiatal dimensions and mean echogenicity of the puborectalis muscle (MEP) are significantly different at 12 weeks' gestation in women who delivered by Cesarean section due to failure to progress compared with those who delivered vaginally. The secondary objective was to assess the association between the echogenicity of the cervix and vastus lateralis muscle and mode of delivery. METHODS: In this prospective multicenter study, 306 nulliparous women with a singleton pregnancy underwent ultrasound assessments of the pelvic floor at rest, on maximum pelvic floor muscle contraction and on maximum Valsalva maneuver, of the cervix and of the vastus lateralis muscle at 12 weeks' gestation. Dimensions of the levator hiatus, MEP and mean echogenicity of the cervix and vastus lateralis muscle were measured and compared according to mode of delivery. RESULTS: Two hundred and forty-nine women were included in the analyses. We were unable to confirm our previous finding that MEP and levator hiatal transverse diameter and area at 12 weeks' gestation are associated significantly with mode of delivery. In addition, we could not demonstrate a significant association between echogenicity of the cervix or vastus lateralis muscle and mode of delivery. Overall, MEP was a mean of 20 points lower in women in the new database as compared with the previous study, despite the use of the same ultrasound equipment. CONCLUSION: In a second, independent multicenter dataset, we were unable to confirm our previous finding that levator hiatal dimensions and MEP on pelvic floor muscle contraction are associated significantly with mode of delivery. We also found no association between echogenicity of the cervix or vastus lateralis and mode of delivery. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice.

BACKGROUND: Despite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness. METHODS: We conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded. RESULTS: We randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients' tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus. CONCLUSION: We conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in Dutch hospitals. TRIAL REGISTRATION: Dutch Trial Register NTR2982.

Systematic lymphadenectomy in patients with clinical stage II endometrial carcinoma: a case report and review of the literature.

OBJECTIVE: The aim of this case report and review of the literature was to evaluate the effect of adding pelvic and/or para-aortic lymphadenectomy to hysterectomy and bilateral salpingo-oophorectomy (BSO) on the five year recurrence-free survival in patients with clinical Stage II endometrial carcinoma. MATERIALS AND METHODS: A Pubmed, Embase, and Cochrane library search was performed to identify relevant articles. After screening, using predetermined exclusion and inclusion criteria, and critical appraisal, a final of four articles remained. RESULTS: This search only revealed studies with a retrospective design. Two articles showed a significant disease-specific survival benefit in patients undergoing systematic lymphadenectomy for Stage II endometrial carcinoma. In multivariate analyses, conducted in both studies, this improvement in survival was also evident (HR 0.75, 95% CI 0.69 - 0.81, p < 0.001 and HR 0.74, 95% CI 0.58 - 0.93, p = 0.0096). The remaining studies revealed a non-significant ten-year recurrence-free survival (77% vs 65%) and five-year overall survival (72% vs 70%) in favour of patients undergoing systematic lymphadenectomy. CONCLUSION: The practise of performing a systematic lymphadenectomy in patients with clinical Stage II endometrial carcinoma as advocated in guidelines, is not based on evidence from randomised clinical trials. However, lymph node dissection seems to improve the five-year disease-specific survival in retrospective studies.

Paraneoplastic hypertrichosis lanuginosa acquisita: uncommon or overlooked?

Acquired hypertrichosis lanugo-type or hypertrichosis lanuginosa acquisita (HLA) is often associated with metabolic and endocrine disorders and use of certain drugs. The occurrence of HLA with malignancy was first noted in 1865, and it has since been described in 56 patients as a paraneoplastic syndrome both in women and in men. Sometimes HLA occurs concurrent with acanthosis nigricans, papillary hypertrophy of the tongue, and glossitis. The predominance of female cases is striking. Malignancy-associated HLA seems to occur especially in the age group 40-70 years. In women with HLA the most frequent malignancy is colorectal cancer, followed in order by lung cancer and breast cancer; in men lung cancer is the malignancy most frequently associated with HLA, followed by colorectal cancer. In 3 years we saw 10 patients with HLA, in whom the malignancy was usually metastasized. Only one patient had local disease; after removal of the primary tumour it took 2 years before the lanugo hair recurred. The aetiology of the syndrome is not clear: no specific hormonal or biochemical abnormalities have been identified as yet. The difference between hirsutism and lanugo-type hypertrichosis is discussed. It is stressed that the appearance of lanugo-type hypertrichosis in body areas previously perceived by patients as 'hairless' is highly indicative of internal malignancy.

[Use of alcohol during conception, pregnancy and lactation]. / Gebruik van alcohol bij conceptie, zwangerschap en lactatie.

Recently, the Dutch Health Council published a report on the risks of the use of alcohol during conception, pregnancy and lactation. Because the medical literature does not prove the safety of the use of small amounts of alcohol, the Health Council recommends using no alcohol whatsoever. One may wonder whether the advice of the Health Council is not too rigid. Since Karl Popper, it is evident that the truth of the hypothesis that the consumption of small amounts of alcohol is safe will never be verified. Because the medical literature also does not prove the harmfulness of the irregular use of small amounts of alcohol, it is not necessary to upset pregnant women who occasionally take an alcoholic beverage. It is preferable to use no alcohol; however, the rare consumption of a single glass does not seem to be harmful.

Infertility in rural Ghana.

OBJECTIVES: This study measured the prevalence of self-reported infertility, as well as the level of knowledge of causes of infertility. Infertility was defined as failure to achieve conception after a minimum of 12 months of exposure. METHODS: Prevalence and knowledge of infertility were assessed in a representative community-based survey using a structured questionnaire in a rural district in Ghana among a random sample of 2,179 men and women from 15 to 49 years. RESULTS: The prevalence of infertility was 11.8% among women and 15.8% among men. The knowledge of causes of infertility was limited; only 46.5% of the respondents reported any cause. Most respondents failed to identify reproductive tract infections as causes of infertility. CONCLUSIONS: Infertility in Ghana and other sub-Saharan countries deserves more recognition as a public health problem. Prevention and treatment of infertility should be incorporated in reproductive health programs, while male participation in reproductive health programs and research needs to be encouraged. Public education about the causes of infertility is recommended.

Abdominal versus vaginal approach for the management of genital prolapse and coexisting stress incontinence.

Patients who undergo surgery because of genital prolapse and coexisting stress incontinence can be treated by a combination of surgical procedures via a unified route. We performed a retrospective study among 47 patients to compare micturition, defecation and prolapse symptoms after surgery, as well as duration of hospital stay and complication rate between patients who underwent a unified vaginal or abdominal surgical correction. All patients were treated between January 1995 and December 1997 in the University Medical Center Utrecht or St Antonius Hospital Nieuwegein, The Netherlands. Abdominal surgery was associated with a higher prevalence of difficulty in bladder emptying (relative risk (RR) 2.3 (95% CI 1.4-8.4)), fecal incontinence (RR 3.4, CI 1.1-10.7) and soiling (OR 2.8, CI 1.2-6.2), as well as with a longer postoperative hospital stay (8.6 vs 7.3 days) and a higher complication rate (25.0% vs. 11.4%) than vaginal surgery. These results suggest that a unified vaginal surgical correction of genital prolapse and coexisting stress incontinence appears to be preferable to a unified abdominal surgical correction.

Malaria prophylaxis and the reduction of anemia at childbirth.

OBJECTIVES: To assess the effect of introducing chloroquine prophylaxis during pregnancy on prevalence of anemia (<10.9 g/dl) at childbirth and perinatal outcome. METHODS: Observational study in a rural district hospital in Ghana, which compared 2803 women who received chloroquine prophylaxis during pregnancy with 3084 historical controls, who had not received prophylaxis during pregnancy. Main outcome measures were hemoglobin level at childbirth, perinatal mortality and birth weight. RESULTS: Mean hemoglobin level before childbirth increased from 10.7 g/dl (S.D.=1.0 g/dl) to 11.0 g/dl (S.D.=0.9 g/dl). Prevalence of anemia decreased from 29.4 to 13.3% (OR=0.4 and 95% CI=0.3-0.4). Prevalence of moderately severe anemia (<9.0 g/dl) decreased from 4.4 to 3.3% (OR=0.7, 95% CI=0.6-0.97). Perinatal mortality and low birth weight (<2500 g) remained unchanged. CONCLUSIONS: Routine chloroquine prophylaxis in pregnancy is useful in reducing anemia at childbirth in malaria-endemic regions. Fetal outcome did not improve with chloroquine prophylaxis in this study.

The effect of immersion on haemodynamic and fetal measures in uncomplicated pregnancies of nulliparous women.

OBJECTIVE: To evaluate the effect of immersion in water on maternal haemodynamic measures and fetal heart rate patterns in healthy nulliparous women. DESIGN: A randomised cross-over study. PARTICIPANTS: Twenty pregnant women were studied between 26-29 weeks and between 34-37 weeks of gestation. METHODS: The women were either immersed in water for 35 minutes or rested on a bed for a similar period of time. Maternal blood pressure, thoracic electrical bioimpedance, urine and blood samples, and fetal heart rate patterns were obtained before and after immersion or bedrest. RESULTS: Compared with bedrest and pre-immersion values, immersion resulted in a significant decrease in blood pressure, which returned to baseline values within 1.5 hour. Urine production increased for a short period after immersion, but 24 hour samples showed no difference compared with bedrest. Sodium, potassium and creatinine levels in urine remained constant. No significant changes were found for the other haemodynamic measures. There were no effects on fetal heart rate nor on its variation. CONCLUSION: In healthy pregnant women immersion for 35 minutes has a clear effect on blood pressure and urine production. However, these effects are short lasting.

A simple strategy to detect significant premenstrual changes.

The prevalence of the ten most prominent premenstrual symptoms (top-ten) was calculated in Dutch women (n = 202), who considered themselves to suffer from complaints related to menstruation. Premenstrual syndrome was diagnosed where the scores of 5 or more of the top-ten symptoms showed an increase of at least 2 points (on a visual analog scale rated from 1 to 10) from day 12 to day 26 during two consecutive cycles. This diagnosis was confirmed in almost all subjects using a 'gold standard' criterion of an increase of at least 30% in complaints from the follicular phase to the luteal phase. In contrast to the latter strategy the 'top-ten' method successfully excluded women who felt free from premenstrual complaints. It is concluded that the 'top-ten' method is a simple and valid strategy to detect significant premenstrual changes.

Is premenstrual syndrome an endocrine disorder?

To both patients and physicians it seems natural to attribute adverse premenstrual phenomena to cyclic fluctuations of hormones produced by the ovary. This seems so plausible that, although the endocrine mechanism that causes premenstrual syndrome remains unknown, the condition itself is often treated with hormonal substances. Psychosocial factors are thus considered to be of only secondary importance. They may play a role as a contributing factor, to the 'real' cause of premenstrual syndrome they are not an essential ingredient. The aim of this review article is to examine how strong the evidence is for the possible existence of an endocrine factor as the causative agent in premenstrual syndrome. Using an epidemiological approach we conclude that the continuing search for the responsible mechanism that causes premenstrual syndrome may very well be an endocrine 'Holy Grail'. Human behavior cannot be understood within a single (hormonal) frame of reference. Cyclical ovarian activity is only one of the etiological factors in premenstrual syndrome. Unravelling the pathogenesis of premenstrual syndrome requires a multidisciplinary approach.

Recurrent abortion and the diagnosis of Wilson disease.

We describe the first patient with Wilson disease and recurrent abortion who was effectively treated with oral zinc for both conditions. Between the ages of 21-26, this patient experienced seven successive unexplained abortions. At age 27, neurologic signs and liver function disturbances appeared. Wilson disease was diagnosed when Kayser-Fleischer rings were detected in the cornea. Decoppering therapy was instituted with zinc sulfate per os. By the age of 31, hepatic and neurologic signs had vanished. The patient conceived, and after an uncomplicated eighth pregnancy she delivered her first healthy child. Two years later, a ninth pregnancy was equally successful. The chance that Wilson disease may be the cause of recurrent abortion is small. However, because the disease is fatal if left untreated and because it is an underdiagnosed disease, we recommend screening for Wilson disease in cases of unexplained recurrent abortion when family history demonstrates consanguinity or neurologic, psychiatric, and/or liver disorders. A strategy to this end is proposed.

Sigmoid volvulus in a West African population.

The incidence, clinical presentation, etiology, and treatment of sigmoid volvulus in a West African population are described. This retrospective study, based on 146 cases in eight years, shows that the incidence of the disorder of 12 new cases per 100,000 population per year is extremely high in the area described. It also shows that good results can be obtained in the treatment of sigmoid volvulus even in suboptimal conditions in rural hospitals when adhering to sound surgical principles.