PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a randomized controlled trial.

BACKGROUND: The PROtocolized Care to Reduce HYpotension after Spinal Anaesthesia (ProCRHYSA trial) is an unblinded, randomized, monocentric, prospective, three-arm, parallel-group trial aimed at assessing the role of a controlled volemic repletion in reducing both clinically significant hypotension rate and total amount of fluid administered in patients undergoing spinal anaesthesia. METHODS/DESIGN: Aim of the study is assessing the effectiveness of a non-invasive tests to guide a titrated volemic repletion before spinal anesthesia in order to reduce post-spinal hypotension rate. After local ethical committee approval of the study (Comitato Etico Cantonale Ref. N. CE2796), we will randomize patients undergoing elective surgery under spinal anesthesia into two parallel groups: in the first vena cava ultrasound will be used in order to assess adequacy of patients' volemic status and consequently guide the administration of crystalloids boluses; in the second passive legs raising test will be used instead of ultrasound for the same purpose. DISCUSSION: The hypothesis we want to test is that the using of these two experimental methods before spinal anaesthesia, compared to the standard method (empirical fluid administration) can reduce the impact of systemic hypotension through an adequate titrated volemic repletion, avoiding both hypotension and fluid overload. The final purpose is to ensure that spinal anaesthesia is performed in the safest way possible. CONCLUSIONS: The study will offer a new insight on the possible role of vena cava ultrasound and passive legs raising test as screening tools to prevent hypotension after spinal anesthesia. These tests were already validated in a critical environment, but to the best of our knowledge this is the first time they are applied to an elective surgical population. TRIAL REGISTRATION: The trial was registered on May 2014 on www.clinicalstrial.gov with the number NCT02070276.

Efficacy and safety of dabigatran in a "real-life" population at high thromboembolic and hemorrhagic risk: data from MonaldiCare registry.

OBJECTIVE: Dabigatran is a novel target specific oral anticoagulant for stroke prevention in non valvular atrial fibrillation. Little is still known about its real-world effectiveness and safety in the italian population. Aim of our study was to evaluate the efficacy and safety of dabigatran in a large single-center cohort of "real-life" italian population with non-valvular AF and to compare the results with those obtained from the RE-LY trial and the Medicare study. PATIENTS AND METHODS: We studied a prospective cohort of 2108 patients (1119 male; mean age 69.4 ± 9.4 years) who started the oral anticoagulant treatment with dabigatran 110 mg twice-daily (DAB 110; N = 1075; 51%) or 150 mg twice-daily (DAB 150; N = 1033; 49%). Follow-up data were obtained trough outpatients visits each 3-6 months for assessing the clinical status, adherence to treatment, occurrence of side effects and major cardiovascular complications. RESULTS: In DAB 150 group the mean age was 64.9 ± 8.8 years, 56.8% of patients was male. CHA2DS2Vasc Score was ≥ 3 in 94.3% and HAS-BLED was ≥ 3 in 59.7%. In DAB 110 group (N = 1075) the mean age was 73.9 ± 7.5 years; 49.5% of patients was male. CHA2DS2Vasc Score was ≥ 3 in 73.4% and HAS-BLED was ≥ 3 in 87.4% of DAB 110 patients. One patient taking Dabigatran 110 mg bid had ischemic stroke without significantly neurological sequelae. In both groups, no patient experienced hemorrhagic stroke during the follow-up period. 147 patients (6.9%) of MonaldiCare population reported adverse effects from treatment with dabigatran, of whom 121 patients (5.7%) discontinued therapy. We reported one case of subarachnoid hemorrhage (0.05%) in a patient with high thrombo-embolic and high hemorrhagic risk score who was taking dabigatran 150 mg bid and one case (0.05%) of bladder bleeding in a patient who was taking dabigatran 110 mg bid. No major gastrointestinal bleeding was observed in the MonaldiCare population. CONCLUSIONS: MonaldiCare registry showed a safety profile of both dosages of dabigatran regarding major of fatal bleeding in a "real life" single center italian population at high thromboembolic and hemorrhagic risk. The majority of MonaldiCare patients tolerated dabigatran treatment without significant side effects. The efficacy of dabigatran was demonstrated by very low prevalence of ictus/TIA, also when patients underwent electrical AF cardioversion independently of the transesophageal examination.

[Endoscopic excisional biopsy with laser CO2 for the diagnosis and treatment of glottic carcinoma (T1-selected T2)]. / Endoscopic excisional biopsy with laser CO2 for the diagnosis and treatment of glottic carcinoma (T1-selected T2).

UNLABELLED: AIMS AND BACKGROUNDS: In T1-T2a glottic carcinoma before considering which type of treatment is the best option a biopsy is necessary. A peculiar aspect of this type of lesions is the fact that in the same specimen it is possible to find different grade of dysplasia even carcinoma in situ or microinvasive or invasive. An incisional biopsy could mislead the diagnosis. The aim of this study was to report the oncological results of the excisional biopsy for T1-T2a glottic cancer. MATERIALS AND METHODS: From November 1999 to December 2001, 18 patients (13 T1, 5 T2a) with carcinoma of the vocal cord underwent excisional biopsy of the lesion. In the case of negative margins no further treatment was done. The average follow-up was 2 years and 3 months. RESULTS: Local control was achieved in 100% for T1, 80% for T2. Radiotherapy was added in 2 cases. CONCLUSION: In our experience "excisional biopsy" for unadvanced glottic tumors is an ideal surgical technique for a one stage procedure of diagnosis and therapy.

[The stapler in total laryngectomy with closed technique]. / The stapler in total laryngectomy with closed technique.

UNLABELLED: AIMS AND BACKGROUNDS: The use of the stapler in total laryngectomy with closed technique is described by the authors. MATERIALS AND METHODS: From October 1999 to December 2002, 27 total laryngectomy were performed, 15 with a stapler and 5 cases had a primary tracheoesophageal puncture. RESULTS: Only one patient developed a pharyngocutaneous fistula, no other patients experienced post-operative complications. All cases in this study had negative surgical margins. CONCLUSION: The correct indication for the use of the stapler is a tumor that needs a total laryngectomy, but completely endolaryngeal. The technique allows to remove the nso-gastric tube at the end of the first week after the operation, to avoid soiling the surgical field, to reduce the time in theatre. This technique seems to be safe as the traditional suture.

[Treatment of the facial nerve and the neck in malignant parotid gland tumors]. / Il trattamento del nervo facciale e del collo nei tumori maligni della ghiandola parotide.

In the surgery of malignancies of the parotid gland the management of the facial nerve and of the neck is very important. In fact, many authors declared as the surgery of parotid gland can be considered as the surgery of facial nerve and others underlined the role of the neck management in a complete treatment of these neoplasms. The features of 47 cases of parotid gland neoplasms observed at the National Cancer Institut of Naples (Naples, Italy) are reported. In all cases a total parotidectomy was performed with neck dissection in case of neck metastases or electively in selected cases and resection of the facial nerve only in case of macroscopic tumor involvement. Radiotherapy was administrated in case of involvement of the facial nerve, and/or of the skin and/or of multiple neck metastases. The results of our experience emphasize as the neoplasms of the parotid gland can be treated sparing the facial nerve when it is clearly not involved without making worse prognosis; on the other side planing a neck dissection should be mandatory in case of high degree malignancies, and/or of tumors larger than T2, and/or of involvement of the facial nerve, and/or of the skin and/or cervical lymph nodes.

Behavioral and neurochemical effects of dopaminergic drugs in models of brain injury.

The dopaminergic drugs, ropinirole and dihydroergocryptine (DHECP) were injected subcutaneously (s.c.) at doses of 0.5 and 1 mg/kg/day for 7 days into male rats of the Sprague-Dawley strain. The drug pretreatment reverted amnesia induced in rats by hypobaric hypopxia and tested in active and passive avoidance tasks. Furthermore, a partial restoration of memory retention was found in animals with a 2-month brain occlusive ischemia induced by manipulation of the four major arteries of the brain. No major changes were found in spontaneous motor activity, but drug treatment increased ambulation of animals subjected to acute or chronic experimental manipulation. In a model of kainate-induced epilepsy, ropinirole or DHECP did not affect seizure parameters, but reduced mortality rate. At the end of behavioral procedures, in all animals subjected to hypobaric hypoxia or to brain occlusive ischemia glutathione redox index (glutathione reduced/glutathione oxidized ratio) was measured in the frontal cortex, striatum and hippocampus. It was found that experimental models of brain injury were followed by a decrease of reduced glutathione content in all brain areas. The glutathione redox index was augmented by ropinirole or DHECP treatment in all brain areas. These behavioral and neurochemical findings suggest that ropinirole and DHECP may exert either protective activity (as found in animals pretreated with these drugs and exposed to hypobaric hypoxia) or reversal of brain injury (as found in animals treated after two-month occlusive brain ischemia). Thus, both drugs may be studied as therapeutic agents in brain injuries of various origin.

Prosthetic infections.

BACKGROUND: The authors report the up to date trends regarding the etiopathology, diagnosis and treatment of vascular-graft infections. This paper concerns the responsible micro-organisms; the reference to the formation of anastomotic pseudo-aneurysm for the infections involving the lines of suture and the reference to the aortoenteric fistula. METHODS: A case study which refers to the period between 1990 and 1999 presents 19 cases of prosthetic infections out of 520 operations of implants of prosthetic materials. RESULTS: 11 successful, 7 amputations, 1 decrease. CONCLUSIONS: In the past years the results of the treatment have improved thanks to a more refined and codified therapeutical conduct and to the employment of prosthetic materials which are more resistant to infection, or to a greater attention paid to asepsis, before, during and after surgery to antibiotic prophylaxis before, during and after the operation. But, nevertheless graft infection still remains a dreadful complication for vascular surgery operations. The therapeutical approach is substantially aggressive and the removal of the infected prosthesis is essential. Nevertheless we believe that we should not underestimate open local treatment, which in localized and superficial infections and infections not involving anastomosis allows us to preserve prosthesis and make it root.

[Popliteal aneurysms. Personal experience]. / Gli aneurismi poplitei. Nostra esperienza.

BACKGROUND: The 70% of peripheral aneurysms are localized at the popliteal artery; approximately one third of patients are asymptomatic, but the occurrence of complications (acute ischemia, rupture) endangers the survival of the leg. The purpose of this paper is to demonstrate the validity of elective surgery for popliteal aneurysms, also for asymptomatic lesions. METHODS: Twenty-seven popliteal aneurysms were observed in 20 patients; only 7 of these were affected by a unilateral lesion, other 7 patients by a bilateral lesion and the remainder 6 patients by a polydistrict association; 3 patients refused the surgical therapy which was proposed. Prosthetic grafting with exclusion or resection of the aneurysm has been practiced in 16 cases; one time only a Dacron graft was employed, while the autologous saphenous vein was employed in 15 cases. A locoregional thrombolysis has been performed in 3 patients, in presence of an acute peripheral ischemia. In 5 cases a conservative approach has been chosen; these were asymptomatic aneurysms with a <2 cm diameter. RESULTS: In 87,5% of patients operated (14/16) a good immediate result was obtained. In a mean 2 years follow-up the 75% of these patients maintained the clinical result. The fibrinolytic therapy was resolutive in 2 cases of acute peripheral ischemia; a lumbar sympathectomy was necessary in one case. CONCLUSIONS: In consideration of the complications that the aneurysmatic disease can give, among which the acute peripheral ischemia is the most dreadful, a surgical approach is widely justified, also in the light of the good results described.