Impact of a new levonorgestrel intrauterine system, Levosert(®), on heavy menstrual bleeding: results of a one-year randomised controlled trial.

OBJECTIVE: To evaluate a new levonorgestrel-releasing intrauterine system (LNG-IUS) called Levosert(®) for the treatment of heavy menstrual bleeding (HMB) in comparison to the reference product Mirena(®). METHODS: A multicentre, randomised, controlled trial, in non-menopausal women diagnosed with functional HMB (defined as menstrual blood loss [MBL] ≥ 80 mL) randomised to either Levosert(®) or Mirena(®) and followed for up to one year. MBL was evaluated using a validated modified version of the Wyatt pictogram. RESULTS: A total of 280 women were randomised (141 to Levosert(®) and 139 to Mirena(®)). During the one-year treatment period, both Levosert(®) and Mirena(®) dramatically decreased MBL and increased haemoglobin and ferritin levels. There were no statistically significant differences between Levosert(®) and Mirena(®) regarding any of the parameters evaluated during the study. Similar bleeding patterns were observed in both groups. Levosert(®) was inserted with the same ease as Mirena(®). Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group. CONCLUSION: Levosert(®), a new LNG-IUS designed to release the same daily amount of LNG as Mirena(®), is highly effective in the treatment of HMB. No differences were observed between Levosert(®) and Mirena(®) regarding all evaluated outcomes, including safety profile.

Quality of life in women with urinary incontinence.

AIM: To determine the characteristics of urinary incontinence and its impact on the quality of life in adult women with urinary incontinence who presented to a tertiary care clinic of Vojvodina from September 2008 to May 2009 for treatment METHODS: We used a prospective case-control study. Cases were defined as patients (47) with urinary incontinence symptoms. Controls (50) were defined as patients without urinary incontinence who presented to a tertiary care gynecology clinic for other reasons. Both, cases and controls, completed two questionnaires recommended for the evaluation of symptoms, The Urinary Distress Inventory, and quality of life impact The Urinary Impact Questionnaire. RESULTS: There was a significant correlation between aging (r=0.614; p<0.01), body mass index (r=0.357; p<0.01) and menopause (r= -0.572; p<0.01) and urinary incontinence. All patients had symptoms of stress incontinence, 61.7% had urge incontinence symptoms, 21.3% voiding difficulty and 85.1% dysuria. Ninety-four patients believed that urinary incontinence impaired their quality of life: 50% of patients reported an impaired ability to do household activities, 59.1% avoided social activities, 70.4% reported an impaired ability to travel more than 30 minutes by car or bus, 88.6% avoided leisure activities, 45.5% of patients had impaired emotional health and 34% felt frustrated. CONCLUSIONS: The dominant type of urinary incontinence in more than half of the respondents was a mixed type, with moderate to very severe problems. Symptoms of urinary incontinence interfere with the performance of everyday household and social activities, causing the appearance of anxiety, depression and frustration, and in more than 50% of women leads to reduced quality of life.

[Most important etiologic factors in the development of genital prolapse].

INTRODUCTION: The incidence of genital prolapse depends on numerous factors. The contribution of race, gender and genetic factors is significant. However, additional factors of initiation, promotion and decomposition are necessary if a person with the genetic predisposition to genital prolapse begins to suffer from it. At least 50% of parous women are believed to suffer from genital prolapse of various degrees. Moreover, the prevalence of genital prolapse increases with age. The prevalence of genital prolapse is expected to be even higher in the future due to the extension of the lifespan of women worldwide. OBJECTIVE: The aim of this study was to determine the most common etiologic factors in the development of genital prolapse in the population of Serbia. METHODS: The study was conducted as prospective and included 50 women who underwent surgical treatment due to the problems caused by genital prolapse. RESULTS: Mean age of the women was 58.74 years. Twenty percent of the women had the menstrual cycle, while 80% were in menopause. Mean menopause period was 8.88 years. None of the women used hormone replacement therapy. Mean BMI was 27.395 kg/m2. Twenty-eight percent of the women were of normal weight, while 72% of the women were obese (42% were obese and 30% were severely obese). Ninety-eight percent of the women were parous, and mean parity was 2.08. Mean birth weight of neonates was 3682.77 g. Sixty-four percent of the women did physical labour and lifted heavy objects. CONCLUSION: Vaginal childbirth is one of the most important initiating factors. The most significant promoting factor is obesity and heavy labour. Ageing and entering menopause are the most important factors of decomposition as well as the occurrence of clinical manifestations of the pelvic floor dysfunction.

[Medico-legal aspects of hysterectomy].

INTRODUCTION: Understanding the lawful implementations of surgical procedures, such as hysterectomy, raises practical questions concerning legal relations between a doctor and his patient, and consequences of this relationship, which may be legally relevant. The modern legal theory and practice consider doctors and patients to be partners. CONSENT AND INFORMATION: Medical practitioners performing surgical procedures are obliged to obtain informed consent. They are also required to inform their patients about indications, course of the operative procedure, postoperative treatment, possible complications during and after the procedure, and quality of life after the operation. Informed conversation should take into account the age, mental status and patient's intellectual abilities. Legal consequences ofsurgical procedures Malpractice litigation mostly concers medical error and negligence. Medical errors should not be confused with ineffective outcome, or complicated postoperative course. Even if the surgical procedure was followed correctly and uneventful outcome took place, there might be some problems. CONCLUSION: A patient has a right to receive complete information from a physician about the specific nature of a proposed treatment. A physician has an obligation to elucidate and justify, treatment he proposes. Certain codification of all operative procedures may facilitate this task. Codification instructions about procedures, in this case hysterectomy, must include indications for a certain type of hysterectomy (subtotal, total, radical), as well as for the operative technique (abdominal, vaginal, laparoscopic). Patient information brochures should be available in print, and include information about indications and potential risks associated with the proposed surgical procedure. In this way, it is possible to prevent the inconveniences which may arise from insufficient knowledge and information about surgical procedures.

[The concept and importance of medical law].

INTRODUCTION: Medical law is a scientific discipline which has not been affirmed in our country, but at law schools in many developed countries it has gained the status of a separate scientific discipline and today it is studied with multidisciplinary cooperation of Schools of Medicine, Schools of Dentistry and Schools of Pharmacy. Generally speaking, medical law concerns the rights and duties of the medical profession. ETHICS AND LEGAL QUESTIONS OF MEDICAL LAW: The progress of scientific research and of new technology used in diagnostics and treatment, opens new fields in terms of responsibility. Most European countries have legal institutions in the field of health care. These include laws and legal acts, as well as codification of professional norms. LAW CONCERNING PHYSISIANS: Apart from the national law, there is also an international law concerning physisians. The World Health Organization and the World Association of Medical Doctors brought the following declarations: Declaration on Promotion of Patients' Rights, the Revised Lisbon Declaration on Patients' Rights, the Revised Helsinki Declaration on Biomedical Research Involving Human Subjects and the Council of Europe's Convention on Human Rights and Biomedicine. CONCLUSION: There is no national order of physicians in Serbia and Montenegro, because chambers of physicians with legal authority and mandatory membership have not been formed. The foundation of Chambers of Physicians of Vojvodina and Montenegro is the first step to goal achieving.

[Accuracy of ultrasonic fetal weight estimation using head and abdominal circumference and femur length].

INTRODUCTION: Former investigations have shown that the accuracy of fetal weight estimation is significantly higher if several ultrasonic fetal parameters are measured, because the total body mass depends on the size of fetal head, abdominal circumference and femur length. The aim of this investigation was to establish the best regression model, that is a number of combinations of fetal parameters providing the most accurate fetal weight estimation in utero in our population. MATERIAL AND METHODS: This prospective study was carried out at the Gynecology and Obstetrics Clinic of the Clinical Center Novi Sad. It included 270 pregnant women with singleton pregnancies within 72 hours of delivery who underwent ultrasound measurements of the biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL). RESULTS: In regard to fetal weight estimation formulas, the deviation was lowest using regression models that simultaneously analyzed four fetal parameters (0. 55%) with SD +/- 7.61%. In these models the estimates of fetal weights were within +/- 5% of actual birth weight in 48.89%, and within +/- 10% of actual birth weight in 81.48%. Good results were also obtained using AC, FL measurements (0.92% +/- 8.20) as well as using AC, HC, FL measurements (-1.45% +/- 7.81). In our sample the combination of AC and FL model gave better results in fetal weight estimation (0.92 +/- 8.20%) than the one using BPD and AC (2.97 +/- 8.83%). Furthermore, the model using parameters AC, HC and FL showed a lower error in accuracy (-1.45 +/- 7.81%) than the model using BPD, AC and FL (2.51 +/- 7.82%). CONCLUSION: This investigation has confirmed that the accuracy of fetal weight estimation increases with the number of measured ultrasonic fetal parameters. In our population the greatest accuracy was obtained using BPD, HC, AC and FL model. In cases when fast estimation of fetal weight is needed, AC, HC, FL model may be appropriate, but if fetal head circumference cannot be measured (amnion rupture and/or fetal head already in the pelvis) the AC, FL model should be used.

Block dissection of inguinofemoral lymph nodes using separate "S" incision in surgical treatment of vulvar carcinoma.

Vulvar carcinomas account for almost 3-5% of all malignant tumors of the female genital organs. The primary therapeutic approach is surgical in all cases. Since 1994, we have used a separate "S" incision for inguinofemoral lymphadenectomy in the treatment of invasive vulvar carcinoma. In the period from 1985 to 2003, 46 patients with invasive forms of vulvar carcinoma were operated at the Department of Obstetrics and Gynecology in Novi Sad. Inguinofemoral lymphadenectomy was performed in 37 (84.4%) patients. During 1994, a wide "block" dissection of the vulva, mons pubis and inguinal area of a "butterfly" shape was performed, whereas during the following period, the operative area was reduced by application of separate inguinal "S" incisions leaving a tissue bridge in between. There were 5 patients with stage I, 1 with stage II and 4 with stage III carcinoma. By applying the technique of two separate inguinal "S" incisions we achieved shortening the intrahospital postoperative period to 14 days and reduction of the risk of wound dehiscence and postoperative complications in the period following 1994.

[Endometrial carcinoma--what are the protocols for?]. / Karcinom tela materice--cemu sluze protokoli?

INTRODUCTION: Endometrial cancer accounts for 10% of all malignant diseases affecting women in Western Europe. Women suffering from colonic, breast and ovarian cancer are at higher risk for developing endometrial carcinoma, which points to the fact that some women have a genetic predisposition for developing endometrial cancer. Precancerous conditions, adenomatous hyperplasias, are rarely diagnosed in our institutions. Treatment of endometrial cancer is individual, but surgeons are required to follow some treatment protocols. The aim of this study was to analyze how well treatment protocols are known and used MATERIAL AND METHODS: This study analyzed parameters of treatment of patients with endometrial cancer treated in two institutions treating oncologic patients in Novi Sad during a ten-year period (1991-2000). Results were obtained from patient records, specialist reports, surgery reports and history of disease. RESULTS: The investigation included 450 patients undergoing surgery for endometrial cancer. The average age was 62.5 years. Most patients underwent surgery in stage one (69.1%), two (14.57%), three (9.38%), zero (3.95%) and stage four (2.96%). Surgeries were performed by 16 surgeons, but none of them performed a standard treatment protocol completely. During the last 10 years 10% of patients did not undergo postoperative radiotherapy, due to outworn facilities and follow up of these patients by control of tumor markers was particularly important. DISCUSSION: The stage distribution of cancers is corresponding to that stated in literature. In regard to surgical approach and using treatment protocols, our surgeons stand behind their foreign colleagues. According to treatment standards of oncologic patients in developed countries, only specialised gynecologists and surgeons oncologists can perform operative treatment of oncologic patients. In regard to criteria in the leading countries of the world, 18 surgical gynecologists oncologists (23 the maximum) are sufficient for the territory of Serbia. CONCLUSION: Inadequate primary surgical treatment significantly increases the cost of therapy by late reoperations or additional postoperative treatment and has a negative effect on survival. In order to group patients and provide a well-educated staff with full work-time and adequate facilities, two (maximum three) institutions are sufficient at the territory of Vojvodina.