Symptoms and General Pathology

All Conditions

Necrosis

Hernia

Hernia, Inguinal

Pathological Conditions, Anatomical

Hernia, Abdominal

Patients operated laparoscopically - PIRS technique

Patients operated by open modified Marcy technique

Operation by its known design for PIRS group

Operation - PIRS

Operation by its known design for MARCY group

Operation - MARCY

Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. Investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.

Inguinal hernia represents the protrusion of the abdominal cavity contents through the inguinal canal. Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare two standard methods that are regularly performed at the University hospital of Split at department of pediatric surgery. These are the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. The choice of operating technique depends solely on the choice of a chosen pediatric surgeon. Given the fact that the child is indicated for an operation, regardless of participation in the study, there are no significant risks of participating in this study, except for possible but rare complications resulting from the peripheral venous blood draw (haematoma, soreness and pain). To carry out this study, the child should be taken (drawn) 3 peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after surgery) from which the laboratory parameters are taken and counted (Leukocytes, C - Reactive Protein, Interleukin 6 and Tumor necrosis factor α).

Lab results would be compared between both groups to find out witch one does the lesser inflammatory stress response on the organism.

Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair

Just investigators have insight in patient data, no such data (names and private data) would be written in the study for publishing

measurement of IL6 in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below

measurement of C - reactive protein in mg/L, change of the value in three time frames like mentioned below

measurement of Tumor necrosis factor alpha in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below

measurement of white blood cell count in 10\^9/L, change of the value in three time frames like mentioned below

University Hospital of Split

M.D.

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Metabolic Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Androgens

Testosterone

Women with polycystic ovaries, oligo or anovulation and hyperandrogenism.

Women with polycystic ovaries and oligo or anovulation without hyperandrogenism

Women with normal ovaries, oligo or anovulation and hyperandrogenism

Total testosterone, bioavailable testosterone, Free androgen index, Total cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, insulinemia, OGTT, HOMA index, Adiponectin, C Reactive Protein

Blood samples, transvaginal ultrasound

Paula S Mereshian, MD

Carolina Fux Otta, MD

Marta Fiol de Cuneo, MD

Polycystic ovary syndrome (PCOS) is a very frequent endocrine disease of women in reproductive age, with an estimated prevalence of 5 to 10 % according to the studied population. In 2003 a committee of experts joined in Rotterdam under the auspice of the American Society for Reproductive Medicine and the European Society for Human Reproduction and Embryology, defined diagnostic criteria. It should include unless two of the following: menstrual irregularities; excess of male hormones (clinic or biochemical) and polycystic ovaries under ultrasound examination; giving rise to four subgroups or phenotypes:

1- Women with polycystic ovaries, hyperandrogenism and oligoamenorrhea . 2. Women with normal ovaries, hyperandrogenism and oligoamenorrhea. 3- Women with polycystic ovaries, oligoamenorrhea without hyperandrogenism. 4- Women with polycystic ovaries, hyperandrogenism with normal menses. PCOS shares components of Metabolic Syndrome for the high prevalence of insulin resistance (abdominal obesity, impaired glucose tolerance, type 2 diabetes, hypertension, endothelial dysfunction, impaired lipid profile and probably cardiovascular disease). All these findings lead us to assume that women with PCOS could have an increased risk of developing cardiovascular disease. Nevertheless it is premature to assume that every PCOS phenotype has the same cardiac and metabolic risk factors. So, it is important to evaluate the endocrine and metabolic characteristic in different phenotypes of PCOS to prevent the co morbidities that predispose to cardiovascular disease. And of course to avoid unnecessary measures in groups that could not show increased risk.

Polycystic ovary syndrome (PCOS) is a very frequent endocrine disease of women in reproductive age, with an estimated prevalence of 5 to 10 % according to the studied population.

Its cause remains not fully understood. PCOS is characterized by hyperandrogenism, chronic anovulation and / or polycystic ovaries. Patients, in a high percentage of cases show obesity, hirsutism, acne, menstrual irregularities and infertility. Clinically and biologically PCOS is a heterogeneous disorder with a not yet clear pathogenesis. Therefore, discussions on its definition and diagnosis still subsist. Seventy years ago Stein and Leventhal published their findings in 7 women with amenorrhea, hirsutism, acne, obesity and polycystic appearance of their ovaries. Since then, diagnostic criteria for PCOS suffered multiple modifications.

In 1990 a group of experts under the auspices of the National Institutes of Health (NIH) considered affected by PCOS every woman with hyperandrogenism and chronic anovulation; after having excluded other specific diseases that mimic that clinic like Cushing's syndrome, androgen secreting tumors and congenital adrenal hyperplasia (NIH criteria). The presence of polycystic ovaries under ultrasound exploration was considered controversial criteria and was not included for diagnosis. In May 2003 a new committee of experts joined in Rotterdam under the auspice of the American Society for Reproductive Medicine (ASRM) and the European Society for Human Reproduction and Embryology (ESHRE), included polycystic ovaries by ultrasound to the physiologic abnormalities for diagnosis. Thus, diagnosis should include unless two of the following: oligo or anovulation; hyperandrogenism (clinic or biochemical) and polycystic ovaries under ultrasound examination.

Rotterdam consensus widened the definition already proposed by NIH in 1990 giving rise to four subgroups or phenotypes:

1- Women with polycystic ovaries, hyperandrogenism and oligoamenorrhea. 2. Women with normal ovaries, hyperandrogenism and oligoamenorrhea. 3- Women with polycystic ovaries, oligoamenorrhea without hyperandrogenism. 4- Women with polycystic ovaries, hyperandrogenism with normal menses. This new criteria increase de prevalence, diversity and also controversy about PCOS. Some authors like Franks accept that the new consensus gave significant advances in the etiological knowledge of the syndrome. Others, like Azziz, proposed that is premature to include ovulating women and the ones with no clear evidence of androgens excess. In the last subgroups is no clear if they have an increased risk of cardiovascular and / or metabolic diseases.

The clinical heterogeneity of the syndrome is the product of a multifaceted process; where converge genetic and environmental influences. Many hypotheses try to explain the primary defect; but insulin resistance (IR) seems the most suitable according to most of studies. IR is present in 60 to 70 % of patients independently of obesity. Compensatory hyperinsulinism has a fundamental role in the pathology of PCOS. In vitro insulin stimulates androgen synthesis in ovary theca cells, acting on its own receptor and inhibits hepatic synthesis of sex hormone binding globulin (SHBG), increasing free testosterone. It also leads to the amplification of LH induced expression of cytochrome P450c 17 alfa (a limiting enzyme in androgen synthesis).

PCOS shares components of Metabolic Syndrome for the high prevalence of IR (abdominal obesity, impaired glucose tolerance, type 2 diabetes, hypertension, endothelial dysfunction, impaired lipid profile and probably cardiovascular disease). Dunaif and Sam using NIH criteria for PCOS diagnosis suggested a sole entity called XX syndrome. Central adiposity seems to play an important role in the development of this metabolic phenotype trough the production of many cytokines and adipocytes derived proteins, known as "adipocytokines". Failures on its regulation could contribute to the development of IR. The late one for itself or trough metabolic disturbances is associated with endothelial dysfunction and atherosclerosis.

Adiponectin is exclusively secreted in adipose tissue and could inhibit the expression of vascular endothelial adhesion molecules induced by TNF-alfa. So, it could be an anti atherogenic effect of adiponectin. In obese subjects and those with type 2 diabetes and IR (whom has a high incidence of coronary atherosclerosis) it was found low plasma levels of adiponectin. Recent studies propose low serum levels of adiponectin as an early marker for metabolic risk in women with PCOS.

C Reactive Protein (CRP), a low grade inflammation marker, has been suggested as an independent predictor of cardiovascular event in women; even more relevant than LDL cholesterol. Those facts have been reassured in the recent publication of Reynolds risk score which adds to the classical ATP III´s Framingham score; the usage of CRP in women, increasing its prognostic value. Higher levels of CRP have been described in women with PCOS compared with normal controls.

All these findings lead us to assume that women with PCOS have an increased risk of developing cardiovascular disease. As there is no universally accepted definition for PCOS, studies that show an association between PCOS and cardiovascular disease are of relative value. Legro stated that "It is premature to assume that every PCOS phenotype has the same cardiac and metabolic risk factors".

So, it is important to evaluate the endocrine and metabolic characteristic in different phenotypes of PCOS to prevent the co morbidities that predispose to cardiovascular disease. And of course to avoid unnecessary measures in groups that could not show increased risk.

Evaluation of Endocrine and Metabolic Parameters in the New Diagnostic Phenotypes of Polycystic Ovary Syndrome

Descriptive, Transversal Study of Evaluation of Cardiovascular Risks Factors and Prevalence of Metabolic Syndrome in the Different Phenotypes of Women With Polycystic Ovary Syndrome

Fundación Florencio Fiorini

Universidad Nacional de Córdoba

Carolina Fux Otta

Infections

Communicable Diseases

Disease Attributes

This group consist of cancer patients with a bacterial infection

This is a group of cancer patients without infection

anders mellemgaard, MD PhD

ole larsen, MD PhD

Infections pose a serious threat to cancer patients in chemotherapy. Prompt diagnosis and treatment is of paramount importance as infections may be life-threatening in immune-compromised individuals. Traditionally, the C-reactive protein (CRP) has been used as a marker of infection. However, the CRP is also often elevated in cancer patients and as a marker CRP may be unreliable in cancer patients. Other markers for infection includes procalcitonin which has been showed to be of some value for the diagnose of bacterial infections.

This study examines procalcitonin as a potential marker of bacterial infection in cancer patients.

Purpose of the study:

Is pro calcitonin a marker for bacterial infection in cancer patients? Is pro calcitonin better than C-reactive-protein to identify cancer patients with a bacterial infection?

Background:

Infections, in particular bacterial, pose a major threat to cancer patients as treatment related immuno-suppression and general weakness increase risk and severity of infections. Prompt identification of patients with a bacterial infection is necessary. Traditionally, fever, leucocytosis and elevated c-reactive protein (CRP) have been used in the evaluation in patients with suspected infection. How-ever, fever may be reduced by analgesics and steroids, leucocytes may be decreased due to anticancer therapy and CRP is in some cases elevated by the cancer disease as such. The diagnosis of bacterial infection is thus more difficult in cancer patients. Recently, pro-calcitonin (PCT) (her dækker maja's godt)

Design of the study:

Two groups will be included in this study:

Group I includes patients in anti-cancer therapy including chemo and radiotherapy, targeted treatment and radiotherapy but not hormone treatment, and without any sign of infection defined as temperature \< 38 C and no focal symptoms of infections. Vital signs are noted and blood tests for haematology, CPR and PCT are drawn. Details about cancer type, stage, treatment history of infections less than 1 month prior and co-morbidity are registered. Data from this cohort will be used to assess median CRP and PCT among non-infected cancer patients. Forty patients will be included.

Group II includes patients in anti-cancer therapy including chemo and radiotherapy, targeted treatment and radiotherapy but not hormone treatment, who is hospitalized with suspected infection (temp\> 38 last 24 hours). At the time of hospitalization, vital signs are noted and blood tests for haematology, CPR and PCT are drawn. Details about cancer type, stage, treatment history of infections less than 1 month prior and co-morbidity are registered. All hospitals records are reviewed after discharge to determine if a certain diagnosis of infection (positive bacteriology), probable infection (negative bacteriology but clinical course consistent with bacterial infection) or non infection was made. Data from this cohort will be used to assess the role of CRP and PCT in prediction of bacterial infection. Forty patients will be included in this study.

Blood will be drawn for CRP and procalcitonin analysis

Procalcitonin as a Marker of Infection in Cancer Patients

The mean procalcitonin value will be compared between two groups of cancer patients with and with-out infections respectively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Inflammatory Stress Response in Pediatric Inguinal Hernia Repair	NCT03203343	Inguinal Hernia... Children, Only Inflammatory Re... Surgery Interleukin-6 Tumor Necrosis ... C Reactive Prot... White Blood Cel...	Operation - PIR... Operation - MAR...	3 Years - 7 Years	University Hospital of Split
Evaluation of Endocrine and Metabolic Parameters in the New Diagnostic Phenotypes of Polycystic Ovary Syndrome	NCT00784615	Polycystic Ovar...	Blood samples, ...	18 Years - 35 Years	Universidad Nacional de Córdoba
Procalcitonin as a Marker of Infection in Cancer Patients	NCT01227109	Infections Cancer Procalcitonin C Reactive Prot...		-	Herlev Hospital
Inflammatory Stress Response in Pediatric Inguinal Hernia Repair	NCT03203343	Inguinal Hernia... Children, Only Inflammatory Re... Surgery Interleukin-6 Tumor Necrosis ... C Reactive Prot... White Blood Cel...	Operation - PIR... Operation - MAR...	3 Years - 7 Years	University Hospital of Split

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