The first comparative double-blind trial on efficacy and safety of ergotamine based five-component combination and sumatriptan in migraine without aura.

BACKGROUND: Dihydroergotamine or ergotamine are the most effective preparations for aborting acute attacks of migraine without aura. OBJECTIVE: The aim of our study was to compare the efficacy and safety of ergotamine based five-component drug combination and sumatriptan in the treatment of moderate to severe acute attacks of migraine without aura. METHODS: The study was designed as a randomized, double-blind, double-dummy, placebo-controlled, parallel arm, multi-center clinical trial. The enrolled patients having migraine without aura were randomized to one of the study arms, ergotamine based five-component drug combination or sumatriptan. RESULTS: In total, 201 patients were randomized to one of the treatment arms. Higher percentage of patients was completely free of the headache two hours after dose administration in the ergotamine-based medication group compared to the sumatriptan group, regardless whether all (51.12 % vs 33.70 %) or only repeated attacks were taken into account (50.91 % vs 23.73 %); the salvage therapy (diclofenac) utilization rate was also lower in the ergotamine-based medication group (relative risk 0.61). Photophobia, phonophobia, and osmophobia were reversed more frequently in the ergotamine-based medication group (51.12 % vs 33.70 %), and failure to abort an attack of the migraine without aura occurred more frequently in the group treated with sumatriptan (1.1 % vs 4.9 %). The headache intensity two hours after ingestion of the study medication increased more frequently with sumatriptan, while other adverse events were rare in both groups. CONCLUSIONS: This study demonstrated higher efficacy and similar safety of ergotamine based fixed drug combination in comparison to sumatriptan, when used in the treatment of an acute attack of the migraine. HIPPOKRATIA 2018, 22(1): 17-22.

Double-Barreled Wet Colostomy versus Ileal Conduit and Terminal Colostomy for Urinary and Fecal Diversion: A Single Institution Experience.

BACKGROUND AND AIMS: The aim of this study was to compare the feasibility and early postoperative outcomes between patients undergoing double-barreled wet colostomy and patients undergoing terminal colostomy and ileal conduit for simultaneous urinary and fecal diversion. MATERIAL AND METHODS: Between 1995 and 2012, we had 181 patients in whom it was necessary to make simultaneous urinary and fecal diversion. This is a retrospective study and patients were divided into two groups, depending on the technique applied for the fecal and urinary diversion. The first group consisted of patients undergoing ileal conduit and terminal colostomy and the second group consisted of patients undergoing double-barreled wet colostomy. RESULTS: Ileal conduit and terminal colostomy was performed in 77 (43%) cases, while wet colostomy was performed in 104 (57%) cases. Median length of stay was shorter for double-barreled wet colostomy (13.1 vs 18.1, p < 0.0001). Median operating times for urinary and fecal diversion were shorter for double-barreled wet colostomy (32 vs 64 min, p < 0.0001). The morbidity was lower for double-barreled wet colostomy (11.5% vs 23.4%, p = 0.0432), retrospectively. The mortality was 3.8% for double-barreled wet colostomy and 10.3% for ileal conduit and terminal colostomy group (p = 0.1282). CONCLUSIONS: Double-barreled wet colostomy is a safe, fast, and simple alternative to traditional ileal conduit and terminal colostomy diversion. The technique is relatively easy to learn, and it reduces the time for urinary and fecal diversion, length of stay, and morbidity rate.

Cytoreductive surgery and modified heated intraoperative intraperitoneal chemotherapy (HIPEC) for advanced and recurrent ovarian cancer -- 12-year single center experience.

BACKGROUND: The present study reviews our 12-year results with cytoreductive surgery and HIPEC in patients with advanced primary and recurrent ovarian cancer. METHODS: During the period from January 1995 to December 2007, 56 patients (31 with primary and 25 with recurrent epithelial ovarian cancer) underwent cytoreductive surgery and HIPEC (Doxorubicin intra-operatively, and cisplatin next 1-5 postoperative days) at our department. RESULTS: 52 (92.8%) patients had no gross residual disease after the complete surgical procedure (Sugarbaker completeness of cytoreduction CC, score 0-1), and 4 patients had macroscopic residual disease (CC-2 or CC-3) Average PCI (peritoneal cancer index) was 13.4 (4-28). Mean follow-up was 56 months (range, 1-135). The median operation time was 279min (range 190 + or - 500min). Median total blood loss was 850mL (range 250 + or - 1550mL). The median survival time was 34.1 months for primary, 40.1 for recurrent ovarian cancer without statistically significance difference (p>0.05) and median disease-free survival was 26.2 months. The PCI was equal or less than 12 in 31 patients and their median survival time was statistically significant longer than median survival time of months for the 25 patients with PCI greater then 12 (p<0.01). Morbidity and mortality rate were 17.8% (10/56) and 1.8% (1/56). CONCLUSION: This series indicates that in the majority of patients with primary and recurrent advanced ovarian cancer, cytoreductive surgery combined with HIPEC can lead to a substantial increase in subsequent rates of disease-free and overall survival.

[Influence of tumor size and intestinal wall invasion on development of colorectal liver metastases].

While the general prognostic factors for colorectal carcinoma have been widely researched, the compound relationships between tumor characteristics and development of colorectal liver metastases have not been clearly understood. The aim of this study was to determine which histopathological characteristics of colorectal cancer may be associated with subsequent development of colorectal liver metastases. We performed retrospective and prospective study which included 80 patients operated for colorectal carcinoma on the First Surgical Clinic of Clinical Center of Serbia in Belgrade. Retrospective group consisted of 40 patients operated between 1992. and 1996. while prospective group included 40 patients treated between 1997. and 2001. We analyzed the size of the tumor, depth of invasion through the intestinal wall, extramural spread of the tumor, infiltration of blood vessels and lymphatics, lymph node involvement, tumor maturation and growth, as well circumferential intestinal involvement. Statistical analysis performed showed highly significant (p<0,01) correlation between the tumor size, degree of maturation of the tumor, extramural spread and involvement of the venules with later development of colorectal liver metastases in both groups.

PCR detection of helicobacter pylori genome in colonic mucosa: normal and malignant.

BACKGROUND AND AIMS: The aim of this study was to detect Helicobacter pylori (H. pylori) in colorectal cancer tissue specimens and relate the possible role of this microorganism in the etiology of colorectal cancer. PATIENTS AND METHODS: From February 2002 to April 2003 83 CRC patients (55 male, 28 female) and 40 control patients (19 male, 21 female) entered the prospective study. The biopsy samples of CRC tissue and normal mucosa were obtained during open surgery on CRC patients. In the control patients biopsy samples were taken during colonoscopy. Pathology confirmed adenocarcinoma in all the CRC patients. The existence of genetic material of H. pylori was determined by detection of the ureA gene by nested PCR. K-ras PCR was also performed on all patients. RESULTS: H. pylori PCR was positive in 1 case (1.2%) of CRC in the tumour tissue and in all 5 samples (6.0%) of the normal colonic mucosa in the cancer patients. The control patients were PCR positive to H. pylori in 13 samples (32.5%). According to Chi-square test, there is no statistical correlation between H. pylori infection and CRC (x2 = 2.9395; p > 0.05) but there is a significant prevalence of H. pylori infection in controls compared to CRC (x2 = 15.5625; p < 0.01). The K-ras PCR showed gene mutations in 19 tumour tissues of CRC (31.6%) and in 2 cases (3.4%) of normal colonic mucosa of CRC patients . In controls K-ras PCR showed one gene mutation (3.0%). There is a significant statistical correlation between K-ras mutation and CRC (x2 = 16.0694; p < 0.01). CONCLUSION: Our established PCR for H. pylori is feasible for CRC tissue as well. However, H. pylori is not considered to play an important role in the pathogenesis of CRC. The identification of K-ras mutations in routine PCR analysis correlates with the presence of CRC.

[Plantago ovata].

Plantago ovata is a high fibre bulk forming laxative. It absorbs water and expands to provide increased bulk and moisture content to the stool. The increased bulk encourages normal peristalsis and bowel motility. Clinical Indications: Constipation, Fecal Incontinence, Hemorrhoids, Ulcerative Colitis, Appetite, Hyperlipidemia, Diabetes mellitus.

[Assessment of the degree of maturity in the wall of pancreatic pseudocysts in relation to choice of surgical procedure].

The aim of this study is to present our experience in the diagnosis and treatment of pancreatic pseudocysts. A pancreatic pseudocyst is an incapsulated collection of pancreatic juice, enclosed by nonepithelial elements, containing a high concentration of pancreatic enzymes, bicarbonates and necrotic detritus. It is a common complication of acute pancreatitis and trauma of the pancreas. In the period between 1996 and 2001, 53 surgical procedures were performed for pancreatic pseudocyst at the Institute for Digestive Diseases (First Surgical University Hospital), 35 male patients (67%) and 17 female patients (33%) underwent surgery. In 39 (75%) patients the method of choice was cystojejunostomy by Roux. In 4 cases distal pancreatectomy for pseudocysts localized within the pancreatic tail was performed, complete pseudocyst excision only was performed in one case and complete pseudocyst excision combined with cystojejunostomy was also performed in one case. Cystogastrostomy and drainage in one case and partial cystectomy and drainage also in one case. Surgical internal drainage is the method of choice for the treatment of pancreatic pseudocysts, involving low morbidity and mortality rates.

[PHLEBODIA (diosmine): a role in the management of bleeding nonprolapsed hemorrhoids].

The aim of this study is to describe a role of diosmine in the management of bleeding nonprolapsed hemorrhoids. From November 2003 to January 2004, 60 patients were treated with Phlebodia (diosmine). Total colonoscopy was performed at the discretion of the authors according to the age, symptoms and genetic factors of the patient. Patients were treated with Phlebodia (diosmine, 3x1, 5 days) and in addition a bulk agent (3,26 g plantago ovata sachet, twice daily, for the period of next three months). Hemorrhoidal bleeding stopped after 3,2 days. Diosmine, used with fiber supplements, rapidly and safely stops bleeding from nonprolapsed hemorrhoids.

Treatment of peritoneal carcinomatosis from colorectal cancer by cytoreductive surgery and hyperthermic perioperative intraperitoneal chemotherapy.

PURPOSE: Peritoneal carcinomatosis from colorectal cancer is resistant to standard treatments and median survival time for patients ranges between 6 and 8 months. Aggressive cytoreductive surgery with hyperthermic intraperitoneal perioperative chemotherapy may increase median survival. METHOD: Patients undergoing cytoreductive surgery and perioperative hyperthermic chemotherapy (mitomycin C, intraoperatively; 5-fluorouracil early post-operatively) for peritoneal carcinomatosis from colorectal cancer from 1996 to 2003 were evaluated retrospectively. RESULTS: From 1996 to 2003, 18 cytoreductive procedures were performed. The post-operative morbidity rate was 44.4% with no treatment related mortality. The median total operation time was 5 h 28 min (range: 3 h 20 min to 7 h 10 min). The median follow-up was 21 months. The median survival was 15 months. CONCLUSION: Surgical debulking and perioperative intraperitoneal chemotherapy improved survival with acceptable morbidity and mortality. Completeness of the resection was the most important prognostic indicator.

[Plantago ovata (Laxomucil) after hemorrhoidectomy]. / Plantago ovata (Laxomucil) posle hemoroidektomije.

The aim of this prospective randomized study is to describe the effects of laxative plantago ovata after open hemorrhoidectomy (Milligan-Morgan). Sixty patients divided into 2 equal groups were included in this study. The first group was treated postoperatively with 2 sachets of bulk agent Laxomucil (3.26 g plantago ovata), twice daily, for a period of twenty days, while the control group was treated with glycerin oil. The p.ovata group patients had a statistically significant shorter postoperative length of hospital stay (2.9 v.s. 4.1 days). Pain after stool was statistically significant more tolerable in the p.ovata group. In conclusion, the application of bulk agent plantago ovata after hemorrhoidectomy shortens the mean postoperative hospital stay, expedites digestive function recovery and lessens the pain after stool.

Management of advanced pelvic cancer by exenteration.

AIM: To describe our results in managing locally advanced primary or recurrent pelvic malignancies. METHOD: Investigations included: clinical, laboratory, endoscopic (rectoscopy and colonoscopy) examinations, ultrasound scan, and CT scan or MRI of the abdomen and pelvis, to determine the extent of the pelvic malignancy. A careful explorative laparatomy of abdomen and pelvis was performed, followed by anterior, posterior or total pelvic exenteration. RESULTS: In the period June 1995-Jan 2002, 7 anterior, 2 posterior and 51 total pelvic exenterations were performed in 60 patients, distributed as follows: 28 for rectal cancer (12 primary, 16 recurrent), 20 for cervical cancer (9 primary, 11 recurrent) and 12 for other pelvic malignancies. The median survival time and overall 5-year survival rates were as follows: primary rectal cancer--50 months and 32%; recurrent rectal cancer--31 months and 17%; primary cervical cancer--46.4 months and 41% and recurrent cervical cancer--23.4 months and 16%. During the same period, 559 of our patients were treated for primary or recurrent rectal cancer by different types of straightforward resection. CONCLUSION: Pelvic exenteration is justifiable in cases of locally advanced primary and recurrent malignancies of rectum, cervical cancer and possibly in cases of other pelvic malignancies.

Cytoreductive surgery for ovarian cancer.

AIM: The aim of this study is to describe the technique of managing peritoneal dissemination in patients with ovarian cancer, based on radical surgical excision and, later, perioperative chemotherapy. METHOD: Treatments included complete surgical resection of the peritoneal disease, and intraperitoneal intraoperative and postoperative chemotherapy, using Adriamycin intraoperatively, and Cis-platinol next 1-5 postoperative days. RESULTS: Eleven cytoreductive procedures were performed between 1996 and 2002. Eight patients with primary ovarian cancer underwent total hysterectomy with bilateral adnexectomy, omentectomy and peritonectomy of the pelvic cavity. In 3 cases with recurrent ovarian cancer, peritonectomy alone was performed. Bowel resection was performed in all patients. The median operation time was 279 min (range 190-500min). Median total blood loss was 919 mL (range 450-1330 mL). The median survival time was 22 months. CONCLUSION: Cytoreductive procedure offers satisfactory results in peritoneal carcinomatosis in patients with advanced primary ovarian cancer.

[Lateral lymphadenectomy in the treatment of rectal carcinoma]. / Lateralna limfadenektomija u lecenju karcinoma rektuma.

The aim of this work is to present existence of the lateral lymphatic spread of metastases in patients with Dukes C low rectal carcinoma (60% of all patients), located at or bellow peritoneal reflexion. Prospective clinical investigation analyzed the group of 64 patients (32 underwent lateral lymphadenectomy and 32 didn't), all treated at Ist Surgical Clinic, Clinical Center of Serbia. Lateral lymphatic spread of metastases was proven by frozen section in 8 cases, so extensive lateral lymphadenectomy was performed. In the group of patients who underwent lateral lymphadenectomy, positive lymph nodes were registered in 18 patients (56.2%); in group of patients operated without lateral lymphadenectomy, metastatic lymph nodes were registered in 12 patients (37.5%). According to results of this investigation, method of lateral lymphadenectomy, as well as extensive lateral lymphadenectomy, is significant for exact determination of postoperative stage of the disease. Also, there is a significant increase in number of patients with Dukes C stage of the disease. In those patients, mesorectectomy alone is not sufficient.

[Cytoreductive procedures in advanced primary ovarian carcinoma]. / Citoreduktivna procedura kod uznapredovalog primarnog karcinoma jajnika.

Female patient, 68, hospitalized due to vaginal bleeding, anaemia and defecation disorder. We have done examinations as follows: clinical and laboratory exams, which confirmed severe anaemia. Explorative curretage of uterus--PH findings: malignant tissue. Rectoscopy: extraluminal compression at lo cm from the anal verge. Irigography: spasticity and extraluminal compression to proximal third of rectum and distal sigmoid colon. Ultrasound of abdomen: solid lobular formation 10 x 7 cm in diameter, on the left side of the urinary bladder, surrounded by thin layer of ascites. Ultrasound of liver: without signs of malignant disease. CT-scan of pelvis and abdomen: metastatic lymph nodes, up to 40 mm in diameter, alongside abdominal aorta; solid-lobular tumor, 10 x 7 cm, on the left side of urinary bladder, which fills the central portion of pelvic cavum. Secundary malignant deposits on the pelvic parietal peritoneum with minimal quantity of ascites (peritoneal carcinomatosis). Intraoperative findings confirmed malignant deposits on the right colon serosa, so we performed right hemicolectomy with ileo-colo anastomosis, omentectomy, hysterectomy, bilateral adnexectomy, low anterior resection of the rectum, peritonectomy of pelvis and reconstruction of digestive tubus by colo-rectal anastomosis with circular stapler ILS 33. Duration of operation was 6:45 hours, blood loss was 1100 ml. Intraoperatively was intraperitonealy applicated Adriamycin. One month after the operation, systemic chemotherapy consisting of Endoxan and Karboblastin was administered, for the duration of 6 months, once monthly. Twelve months after the operation NMR showed normal findings, patient was without evidents of recurrent disease.

[Pelvic exenteration]. / Pelvicna egzentereza.

Pelvic exenteresis (total, anterior and posterior) is operative procedure reserved for the local advanced malignancies of the pelvis. In the period 1995-2001, we have treated 54 patients (20 male, 34 female) by this procedures. By anterior pelvic exenteresis we have treated 6 females for: Ca vesicae urinary (4 pts). Ca PVU after irradiation therapy (1 patient), Ca urethrae (1 patient). By posterior pelvic exenteresis we have treated 2 females for primary advanced Ca of the rectum. By total pelvic exenteresis we have treated 46 pts (20 male, 26 female): Ca PVU after irradiation therapy (10 females), recidivant Ca PVU (8 females), primary advanced Ca of the rectum (7 male, 1 female), recidivant Ca of the rectum (10 male, 7 female), recidivant Schwanoma (1 male), recidivant Sa stromae endometrii (1 female), recidivant Ca vesicae urinary (1 female). The median survival time of all 54 patients was 24 months. Early postoperative mortality was 18% (10 pts). Twenty patients died with median survival of 18 months (range 4-48 months). Twenty one patients are alive without evidence of disease with median follow up period of 41 months (range 6-60 months). Three patients were lost from follow up. Exenteresis pelvis is very complicate operative procedure and it should be limited to perform only in couple surgical centers.