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  1. Article: Adrenal Cysts: To Operate or Not to Operate?

    Bozic Antic, Ivana / Djurisic, Igor / Nikolic, Srdjan

    Journal of clinical medicine

    2024  Volume 13, Issue 3

    Abstract: Adrenal cysts are uncommon and usually asymptomatic, and therefore are usually incidentally discovered adrenal lesions. They have a broad pathohistological spectrum that includes pseudocysts and endothelial (vascular), parasitic, and epithelial ( ... ...

    Abstract Adrenal cysts are uncommon and usually asymptomatic, and therefore are usually incidentally discovered adrenal lesions. They have a broad pathohistological spectrum that includes pseudocysts and endothelial (vascular), parasitic, and epithelial (mesothelial) cysts. Although most adrenal cysts are benign and hormonally non-functional lesions, some can have ambiguous imaging appearances and mimic malignant adrenal neoplasms. On the other hand, the actual malignant neoplasms could undergo cystic transformation. Additionally, immune cell infiltrations, thrombosis, or haemorrhage seen in sepsis can frequently cause adrenal cyst development, raising a question about the possible connection between severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) and adrenal cystic lesions. Due to the disease's rarity, the likelihood of malignancy, and the lack of specific guidelines, the management of adrenal cysts is always challenging especially in a young person. This review discusses the important diagnostic and the current treatment possibilities for adrenal cystic lesions. Aiming to emphasize clinical dilemmas and help clinicians navigate the challenges when encountering a patient with an adrenal cyst in everyday practice, we based our review on a practical question-answer framework centred around the case of a young woman with an incidentally discovered large adrenal cyst.
    Language English
    Publishing date 2024-02-01
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm13030846
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  2. Article: The impact of different infusion solutions on postoperative recovery following colorectal surgery.

    Cvetkovic, Ana / Kalezic, Nevena / Milicic, Biljana / Nikolic, Srdjan / Zegarac, Milan / Gavrilovic, Dusica / Stojiljkovic, Dejan

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2018  Volume 23, Issue 5, Page(s) 1369–1379

    Abstract: Purpose: The purpose of this study was to compare two groups in postoperative recovery, whether there were any complications and whether the length of their hospital stay differed. One group received intraoperatively a combination of crystalloids and a ... ...

    Abstract Purpose: The purpose of this study was to compare two groups in postoperative recovery, whether there were any complications and whether the length of their hospital stay differed. One group received intraoperatively a combination of crystalloids and a small colloid dose, while the other group received only the crystalloids intraoperatively.
    Methods: This randomized prospective study included 80 patients with colorectal cancer prepared for major elective colorectal surgery. The patients were randomly assigned to either the control group (CG) which received only crystalloid solutions intraoperatively or to the research group (RG) which received a combination of colloid and crystalloid solutions. Regional and general endotracheal anesthesia techniques were combined in all patients. Goal-directed fluid therapy was administered to patients in both groups. After extubation, patients were transferred in the Intensive Care Unit (ICU). We measured the administered fluids, fluid balance, the volume of received red packed cells (RPC) and fresh frozen plasma (FFP). Recorded were the first bowel movement, the first flatus, the tolerance on oral food, complications by Clavian-Dindo classification, days of patient's recovery delay in the ICU, Surgery Department (SD) and the total length of hospital stay (LOS).
    Results: Statistically significant differences were present in all parameters of postoperative recovery. RG patients showed better results relative to the CG patients. RG patients were faster in restoring bowel movement and peristalsis, get the first postoperative stool and re-acquire oral food tolerance. According to the Clavian-Dindo classification of complications, no significant difference between these two groups was noted.
    Conclusions: Goal-directed colloid-crystalloid therapy significantly improved postoperative recovery.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Colorectal Neoplasms/surgery ; Colorectal Surgery/methods ; Female ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Postoperative Complications/etiology ; Postoperative Complications/pathology ; Prospective Studies ; Young Adult
    Language English
    Publishing date 2018-12-20
    Publishing country Greece
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  3. Article: Prognostic factors and outcomes of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy in patients with advanced ovarian cancer - A single tertiary institution experience.

    Kocic, Milan / Nikolic, Srdjan / Zegarac, Milan / Djurisic, Igor / Soldatovic, Ivan / Milenkovic, Petar / Kocic, Jovana

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2016  Volume 21, Issue 5, Page(s) 1176–1183

    Abstract: Purpose: Ovarian cancer (OC) ranks fifth in mortality among females cancer patients. Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) have radically changed the treatment of OC. The aim of this study was to evaluate ... ...

    Abstract Purpose: Ovarian cancer (OC) ranks fifth in mortality among females cancer patients. Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) have radically changed the treatment of OC. The aim of this study was to evaluate overall survival (OS) and disease-free survival (DFS) in our patient population after the application of combined CRS and HIPEC treatment.
    Methods: The study included patients who met defined inclusion and exclusion criteria and had undergone CRS of peritoneal carcinomatosis from 2006 to 2011. Tumor extension was intraoperatively calculated using peritoneal cancer index (PCI). After CRS had been performed, selected patients underwent closed HIPEC. Assessment of successful surgery was estimated with the completeness of cytoreduction score.
    Results: The study involved 31 patients. The median DFS was 19 months. The DFS for 1 and 2-year period were 69.2 and 35.2%, respectively. The mean OS was 51 months. The 1-, 2- and 5-year OS was 85.4, 63.3 and 56.3%, respectively. PCI ranged from 1 to 24 and the majority (77.4%) of the patients had PCI score below 13. The most frequent carcinomatosis was observed in the omentum (80.6%), followed by adnexae (61.3%), uterus (58.1%), colon (58.1%). spleen (25.8%), diaphragm (25.8%), small intestine (19.4%), bursa omentalis 19.4, liver (9.7%), and pancreas (3.2%).
    Conclusion: The results of the current study are in concordance with the literature which clearly favors combined the CRS and HIPEC treatment. The reported data suggest that this method could be successfully applied in our region and outline the necessity of future multicentric studies that will involve major regional hospitals.
    MeSH term(s) Adult ; Aged ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Chemotherapy, Adjuvant ; Cytoreduction Surgical Procedures/adverse effects ; Cytoreduction Surgical Procedures/mortality ; Databases, Factual ; Disease-Free Survival ; Female ; Humans ; Hypothermia, Induced/adverse effects ; Hypothermia, Induced/mortality ; Kaplan-Meier Estimate ; Middle Aged ; Ovarian Neoplasms/mortality ; Ovarian Neoplasms/pathology ; Ovarian Neoplasms/therapy ; Peritoneal Neoplasms/mortality ; Peritoneal Neoplasms/secondary ; Peritoneal Neoplasms/therapy ; Proportional Hazards Models ; Risk Factors ; Serbia ; Time Factors ; Treatment Outcome
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2016-09
    Publishing country Greece
    Document type Journal Article
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  4. Article: Treatment outcome in patients with breast conserving surgery after neoadjuvant therapy for breast carcinoma - a single institution experience.

    Martinovic, Aleksandar / Santrac, Nada / Bozovic-Spasojevic, Ivana / Nikolic, Srdjan / Markovic, Ivan / Lukic, Branko / Gavrilovic, Dusica / Granic, Miroslav / Dzodic, Radan

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2018  Volume 23, Issue 4, Page(s) 883–890

    Abstract: Purpose: The aim of this study was to analyze outcomes of breast conserving surgery (BCS) after neoadjuvant treatment (NAT) in comparison to radical mastectomy (RM) after NAT in terms of disease-free survival (DFS), overall survival (OS) and patients' ... ...

    Abstract Purpose: The aim of this study was to analyze outcomes of breast conserving surgery (BCS) after neoadjuvant treatment (NAT) in comparison to radical mastectomy (RM) after NAT in terms of disease-free survival (DFS), overall survival (OS) and patients' satisfaction with the esthetic outcomes of surgery.
    Methods: This prospective study was conducted at the National Cancer Research Center of Serbia, Belgrade, from January 1st 2011 to December 31st 2015, on breast carcinoma patients receiving NAT. Treatment outcome was assessed by MDAPI (MD Anderson Prognostic Index). Female patients (n=52) with satisfactory clinical response to NAT and MDAPI scores 0 or 1 were included into the treatment group (NAT-BCS group). The control group (NAT-RM group) consisted of patients (n=52) with poorer clinical response and MDAPI scores 2 to 4. On check-ups, local or distant relapses were noted and both groups were asked to value their satisfaction with the esthetic outcomes of surgery using the Likert scale.
    Results: OS was 100% in both groups. DFS was 96.1% in NAT-BCS group and 100% in NAT-RM group. Local recurrences were observed in two patients from the age group ≥60 years, with initial disease stage IIIA and "clear" resection margins on frozen section study. Patients in the NAT-BCS group were more satisfied with the esthetic outcome of surgery than the control group.
    Conclusions: BCS after NAT provides good esthetic outcome and is oncologically safe if adequate clinical response is achieved after NAT and if established criteria for patient selection are followed.
    MeSH term(s) Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Breast Neoplasms/surgery ; Female ; Humans ; Middle Aged ; Neoadjuvant Therapy/methods ; Prospective Studies ; Treatment Outcome
    Language English
    Publishing date 2018-10-24
    Publishing country Greece
    Document type Journal Article
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  5. Article: Goblet cell carcinoid of the appendix. Review of the literature a propos of a rare case of endometrial metastases.

    Zegarac, Milan / Nikolic, Srdjan / Kolarevic, Daniela / Kocic, Milan / Djurisic, Igor / Inic, Zorka / Buta, Marko / Cvetkovic, Ana / Markovic, Ivan

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2018  Volume 23, Issue 4, Page(s) 867–871

    Abstract: Background: Carcinoid tumors are rare tumors most commonly found in the gastrointestinal tract. They represent the most common malignancies of the appendix. As a distinct entity from both adenocarcinomas and carcinoids, Goblet cell carcinoid (GCC) was ... ...

    Abstract Background: Carcinoid tumors are rare tumors most commonly found in the gastrointestinal tract. They represent the most common malignancies of the appendix. As a distinct entity from both adenocarcinomas and carcinoids, Goblet cell carcinoid (GCC) was initially described in the literature in 1969. The GCC is almost exclusive to the appendix, but rarely can be found in rectum, ileum and colon. More than 50% of the patients at the time of diagnosis already have advancedstage disease. The most common metastatic sites are the peritoneal surfaces of the pelvis and abdominal cavity, and ovaries in women. Surgery is the main form of treatment in patients with GCC.
    Case presentation: A 49-year-old woman was treated at the Institute of Oncology and Radiology of Serbia with histopathological findings of GCC. In a 8-year period the patient was treated with initial appendectomy and three more operations because of locoregional disease progression. The last operation was performed in March 2016 because of endometrial metastases. Since then the patient is on regular follow up without disease progression.
    Conclusion: GCC is a very rare entity. Multidisciplinary approach is necessary for adequate patient treatment.
    MeSH term(s) Adult ; Appendiceal Neoplasms/complications ; Appendiceal Neoplasms/mortality ; Appendiceal Neoplasms/pathology ; Carcinoid Tumor/complications ; Carcinoid Tumor/mortality ; Carcinoid Tumor/pathology ; Endometrial Neoplasms/mortality ; Endometrial Neoplasms/pathology ; Endometrial Neoplasms/secondary ; Female ; Humans ; Prognosis ; Survival Analysis
    Language English
    Publishing date 2018-10-24
    Publishing country Greece
    Document type Case Reports ; Journal Article ; Review
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  6. Article: Hemodynamic stability achievement by application of goal directed fluid therapy with different infusion solutions in colorectal surgery.

    Cvetkovic, Ana / Kalezic, Nevena / Milicic, Biljana / Nikolic, Srdjan / Zegarac, Milan / Stojiljkovic, Dejan / Goran, Merima / Stojanovic, Marina

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2018  Volume 23, Issue 2, Page(s) 329–339

    Abstract: Purpose: To determine whether there was a correlation between the type of administered infusion solutions intraoperatively with the quantity of administered infusion solutions, differences in values of cardiac output (CO) and cardiac index (CI) and need ...

    Abstract Purpose: To determine whether there was a correlation between the type of administered infusion solutions intraoperatively with the quantity of administered infusion solutions, differences in values of cardiac output (CO) and cardiac index (CI) and need to use vasopressors and inotropes, between control and research groups.
    Methods: This randomized prospective study included 55 patients with colorectal cancer. Subjects in the control group received only crystalloid solutions intraoperatively and postoperatively. The patients in the research group received a combination of colloid in dosage of 10mg/kg and crystalloid solutions. Patients in both groups were given goal directed fluid therapy.
    Results: The control group received a significantly larger amount of crystalloid solution per kg of body weight during the entire surgical operation, in comparison with the volume of crystalloids in the research group (mean±SD 50.78±28.13 vs. 31.63±25.60 respectively, p=0.01). During the first hour of the surgery, the control group received a larger quantity of fluid in comparison with the research group (mean±SD 31.14±9.78 vs. 22.17±9.92 respectively, p=0.001). From the beginning of anesthesia until 6th postoperative hr the values of CI were significantly higher in the research group in comparison with the control group.
    Conclusions: Goal directed fluid therapy with colloids, followed by crystalloids during surgery, decreased the total intraoperative fluid volumes, and provided higher values of CI intraoperatively which were also maintained postoperatively.
    MeSH term(s) Aged ; Anesthesia ; Colloids/administration & dosage ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/pathology ; Colorectal Neoplasms/surgery ; Colorectal Surgery ; Crystalloid Solutions/administration & dosage ; Female ; Fluid Therapy ; Hemodynamics/drug effects ; Humans ; Intraoperative Care ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome
    Chemical Substances Colloids ; Crystalloid Solutions
    Language English
    Publishing date 2018-05-09
    Publishing country Greece
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  7. Article: Immunohistochemical study of cyclin A and p16 expression in patients with renal cell carcinoma.

    Latic, Dragana / Radojevic-Skodric, Sanja / Nikolic, Srdjan / Prvanovic, Mirjana / Lazic, Miodrag / Dzamic, Zoran / Bogdanovic, Ljiljana / Radunovic, Milena / Vukovic, Marina

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2017  Volume 22, Issue 5, Page(s) 1322–1327

    Abstract: Purpose: Renal cell carcinoma (RCC) is the most common malignant kidney tumor in adults. Dysregulation of the cell cycle can lead to cancer development. In this study, the mitosis-associated cyclin A and p16, a negative controller, were investigated as ... ...

    Abstract Purpose: Renal cell carcinoma (RCC) is the most common malignant kidney tumor in adults. Dysregulation of the cell cycle can lead to cancer development. In this study, the mitosis-associated cyclin A and p16, a negative controller, were investigated as potential key points in the RCC development.
    Methods: This retrospective study included 74 patients with RCC. The expression of cyclin A and p16 and their correlation to histopathological parameters (TNM stage, histological subtype, nuclear grade, tumor size), gender, age, and clinical outcome were studied and analyzed.
    Results: The highest median value for cyclin A (40%; range 0-70)) and for p16 (57.5%); range 35-80) were found in the papillary histological subtype. Survival analysis showed that in the group of patients that had died before September 2015, the median value for cyclin A was 20% (range 0-60), which was significantly higher than 5% (range 0-70), found in the group of patients that survived (p=0.019).
    Conclusions: In relation to the histological subtype, the papillary type of RCC was associated with a significantly higher expression of cyclin A and p16 compared to other subtypes of RCC. High expression of cyclin A indicated worse prognosis, therefore cyclin A could be considered to be a significant prognostic marker.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Carcinoma, Renal Cell/genetics ; Carcinoma, Renal Cell/mortality ; Carcinoma, Renal Cell/pathology ; Cyclin A/metabolism ; Female ; Genes, p16/physiology ; Humans ; Immunohistochemistry/methods ; Kidney Neoplasms/genetics ; Kidney Neoplasms/mortality ; Kidney Neoplasms/pathology ; Male ; Middle Aged ; Retrospective Studies ; Survival Analysis
    Chemical Substances Cyclin A
    Language English
    Publishing date 2017-11-13
    Publishing country Greece
    Document type Journal Article
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  8. Article: Hyperthermic intrathoracic chemotherapy (HITHOC) in ovarian carcinoma - a propos of a case.

    Stojiljkovic, Dejan / Nikolic, Srdjan / Cvetkovic, Ana / Jokic, Vladimir / Spurnic, Igor / Jokic, Stevan / Goran, Merima / Kocic, Milan / Miletic, Nebojsa / Filipovic, Jovan / Stojiljkovic, Tanja / Lukac, Branislav

    Journal of B.U.ON. : official journal of the Balkan Union of Oncology

    2019  Volume 23, Issue 7, Page(s) 153–155

    Abstract: A female patient aged 42, started chemotherapy for advanced ovarian carcinoma in June 2016. Considering intraoperative findings, cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) were performed, followed by adjuvant ... ...

    Abstract A female patient aged 42, started chemotherapy for advanced ovarian carcinoma in June 2016. Considering intraoperative findings, cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) were performed, followed by adjuvant chemotherapy. In March 2018, computed tomography (CT) examination showed disease progression in the form of pleural carcinomatosis with increased levels of tumor markers. In April 2018, total parietal pleurectomy, partial visceral pleurectomy, and then hyperthermic intrathoracic chemotherapy (HITHOC) with cisplatin were performed. The procedure was uneventful, as was the postoperative course. The patient was discharged on the 13th postoperative day with no major postoperative complications. Three months after surgery, CT showed no signs of disease relapse. Since this is a relatively new method of treating pleural carcinomatosis, real results are to be expected with larger series of patients and longer postoperative follow-up.
    MeSH term(s) Adult ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Chemotherapy, Cancer, Regional Perfusion/methods ; Combined Modality Therapy ; Female ; Humans ; Hyperthermia, Induced/methods ; Ovarian Neoplasms/pathology ; Ovarian Neoplasms/therapy ; Peritoneal Neoplasms/secondary ; Peritoneal Neoplasms/therapy ; Prognosis
    Language English
    Publishing date 2019-02-02
    Publishing country Greece
    Document type Case Reports ; Journal Article
    ZDB-ID 2040386-0
    ISSN 2241-6293 ; 1107-0625
    ISSN (online) 2241-6293
    ISSN 1107-0625
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  9. Article ; Online: Diabetes mellitus and coronary microvascular function in asymptomatic patients with severe aortic stenosis and nonobstructed coronary arteries.

    Banovic, Marko / Brkovic, Voin / Nedeljkovic, Ivana / Nedeljkovic, Milan / Popovic, Dejana / Djordjevic-Dikic, Ana / Ristic, Arsen / Nikolic, Srdjan / Beleslin, Branko

    Diabetes & vascular disease research

    2016  Volume 13, Issue 3, Page(s) 220–227

    Abstract: Background and aim: Coronary flow reserve is impaired in asymptomatic patients with aortic stenosis and has a prognostic value. We investigated whether the type II diabetes mellitus additionally impairs microvascular circulation assessed by coronary ... ...

    Abstract Background and aim: Coronary flow reserve is impaired in asymptomatic patients with aortic stenosis and has a prognostic value. We investigated whether the type II diabetes mellitus additionally impairs microvascular circulation assessed by coronary flow reserve in patients with asymptomatic severe aortic stenosis, normal left ventricular ejection fraction and nonobstructed coronary arteries.
    Methods: A total of 128 patients, mean age of 66.35 ± 10.51 (58.6% males), with severe aortic stenosis and normal left ventricular ejection fraction were enrolled in this study. Patients with diabetes mellitus, those who were treated for diabetes mellitus or had documentation confirming the diagnosis of diabetes mellitus, were considered. All patients underwent coronary angiography and had no obstructive coronary disease (defined as having no stenosis >50% in diameter), standard transthoracic Doppler-echocardiographic study and adenosine stress transthoracic echocardiography for coronary flow reserve measurement.
    Results: Diabetes mellitus was present in 26 patients (20.31%). There was no significant difference in aortic stenosis severity between diabetic and non-diabetic patients [aortic valve area (0.81 ± 0.18 vs 0.85 ± 0.15 cm(2)) and Vmax (4.20 ± 0.57 vs 4.21 ± 0.48 m/s)]. Mean coronary flow reserve in diabetic patients was 1.98 ± 0.48, while mean coronary flow reserve in non-diabetic patients was 2.64 ± 0.54 (p < 0.01). Diabetes mellitus was independent predictor of coronary flow reserve [B = -0.636, 95% confidence interval (-0.916 to -0.368), p < 0.001].
    Conclusion: Diabetes mellitus additionally impairs coronary microvascular function in asymptomatic patients with severe aortic stenosis and nonobstructed coronary arteries.
    MeSH term(s) Adenosine/administration & dosage ; Aged ; Aortic Valve Stenosis/complications ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/physiopathology ; Asymptomatic Diseases ; Case-Control Studies ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/etiology ; Coronary Artery Disease/physiopathology ; Coronary Circulation ; Coronary Vessels/diagnostic imaging ; Coronary Vessels/physiopathology ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/diagnosis ; Diabetic Angiopathies/diagnostic imaging ; Diabetic Angiopathies/etiology ; Diabetic Angiopathies/physiopathology ; Echocardiography, Doppler ; Echocardiography, Stress/methods ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Microcirculation ; Microvessels/diagnostic imaging ; Microvessels/physiopathology ; Middle Aged ; Prognosis ; Risk Factors ; Severity of Illness Index ; Stroke Volume ; Time Factors ; Vasodilator Agents/administration & dosage ; Ventricular Function, Left
    Chemical Substances Vasodilator Agents ; Adenosine (K72T3FS567)
    Language English
    Publishing date 2016
    Publishing country England
    Document type Journal Article
    ZDB-ID 2250793-0
    ISSN 1752-8984 ; 1479-1641
    ISSN (online) 1752-8984
    ISSN 1479-1641
    DOI 10.1177/1479164115627107
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  10. Article ; Online: A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections.

    Bjelović, Miloš / Ayguasanosa, Jaume / Kim, Robin D / Stojanović, Miroslav / Vereczkei, András / Nikolić, Srdjan / Winslow, Emily / Emre, Sukru / Xiao, Gary / Navarro-Puerto, Jordi / Courtney, Kecia / Barrera, Gladis

    Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract

    2018  Volume 22, Issue 11, Page(s) 1939–1949

    Abstract: Background: Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.: Methods: In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with ... ...

    Abstract Background: Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.
    Methods: In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T
    Results: The rate of hemostasis by T
    Conclusions: FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.
    MeSH term(s) Adult ; Aged ; Blood Loss, Surgical/prevention & control ; Cellulose, Oxidized/adverse effects ; Cellulose, Oxidized/therapeutic use ; Female ; Fibrin Tissue Adhesive/adverse effects ; Fibrin Tissue Adhesive/therapeutic use ; Hemostasis, Surgical/methods ; Hemostatics/adverse effects ; Hemostatics/therapeutic use ; Hepatectomy/adverse effects ; Humans ; Hypotension/etiology ; Male ; Middle Aged ; Nausea/etiology ; Pain, Procedural/etiology ; Prospective Studies ; Time Factors
    Chemical Substances Cellulose, Oxidized ; Fibrin Tissue Adhesive ; Hemostatics ; Surgicel (82347-53-3)
    Language English
    Publishing date 2018-07-02
    Publishing country United States
    Document type Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2012365-6
    ISSN 1873-4626 ; 1934-3213 ; 1091-255X
    ISSN (online) 1873-4626 ; 1934-3213
    ISSN 1091-255X
    DOI 10.1007/s11605-018-3852-4
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