Prophylaxis of infection with intravenous immunoglobulins plus antibiotic for patients at risk for sepsis undergoing surgery for colorectal cancer: results of a randomized, multicenter clinical trial.

BACKGROUND: The results of a randomized, multicenter clinical trial with perioperative short-term antibiotic plus intravenous immunoglobulins (IVIG + A) versus antibiotic alone (A) for prevention of postoperative infections in patients at risk for sepsis undergoing surgery for colorectal cancer are presented. METHODS: The patients at risk for sepsis were selected by an original multiparametric test based on delayed-hypersensitivity skin testing and serum protein electrophoretic subfractions. This screening had shown 76% positive predictability in a previous validation assessment. Eighty patients at risk for sepsis were selected prospectively from 210 patients undergoing surgery for colorectal cancer; 43 patients were randomly assigned to the IVIG + A group and 37 to the A group. IVIG was administered on the day before operation, on the first and fifth postoperative days. RESULTS: There was a clear-cut reduction of postoperative infections in the IVIG + A group: 21 infections in 20 patients versus 37 infections in 29 patients in the A group (p less than 0.004). With regard to serum immunoglobulin (Ig) G monitoring, basal IgG levels were significantly lower in patients given IVIG + A who had postsurgical infections (p less than 0.005) compared with patients with a regular outcome, whereas the same was not true in the A group of patients. CONCLUSIONS: A significant decrease (p less than 0.001) of postoperative IgG was evidenced in the A group of patients who had infections as opposed to a significant increase (p less than 0.001) of postoperative IgG in IVIG + A patients with a normal outcome.

Immunoprophylaxis in "septic risk" patients undergoing surgery for gastrointestinal cancer. Results of a randomized, multicenter clinical trial.

The results of a randomized, multicenter clinical trial of immunoprophylaxis of post-operative infections with intravenous Immunoglobulins (IVIG) (Sandoglobulin) in "septic-risk" patients undergoing surgery for gastrointestinal cancer are presented. "Septic-risk" patients were selected by an original multiparametric test based on delayed hypersensitivity skin testing and serum protein electrophoretic sub-fractions. This screening test had shown 76% positive predictivity in a previous validation assessment. In the present study, 159 "septic-risk" patients were selected prospectively from 369 patients undergoing colo-rectal (colon) and other kinds of gastrointestinal (non-colon) oncologic surgery: 80 "septic-risk" patients were included in the colon and 79 in the non-colon group. Immunoprophylaxis with IVIG (15 g on the day prior to operation, on the 1st and 5th postoperative days) was randomly associated with antibiotic prophylaxis (cefoxitin: 2 g one hour prior to, followed by 2 g at the end of operation plus 2 g every six hours for 24 hours) in colon surgery while the prophylactic schedule in non-colon surgery was only based on random administration of IVIG, at the same dosage as in the colon group. There was a clear-cut reduction of post-operative infections both in colon and non-colon "septic-risk" patients who had IVIG prophylaxis; in the colon group, 37 and 21 infections (P < 0.004) in antibiotic (A) versus IVIG plus antibiotic (IVIG + A) subset, respectively; in the non-colon group, 33 and 19 infections (P < 0.01) in control (C) versus (IVIG) subset, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

[Smoking as a risk factor in arteriopathies]. / Il fumo come fattore di rischio nelle arteriopatie.

Tobacco use represents the most powerful chemical addiction, which has been defined as "the inability to discontinue smoking" and it is one of the main cardiovascular risk factors. It produces alterations in platelet activity, blood viscosity and vascular wall and clinical signs related to the different vascular districts. The probability of carotid lesions increases up to 32% for 10 years/smoking and the progression of the disease is proportional to tobacco consumption; on the contrary smoking cessation may be helpful. Furthermore the risk of PAOD increases 2 to 9-fold, irrespective the number of cigarettes and these modify significantly the long-term patency of the femoro-distal reconstructions (57% vs 78% at 2 years). Very impressive indeed the data concerning major amputations (21% vs 2%) and the mortality rate for cardiovascular diseases (83% vs 33%) between smokers and non-smokers. For the abdominal aortic aneurysm too smoking represents the main independent risk factor and the mortality rate rises 6 to 25-fold compared to the normal population. The conclusions are obvious and can be shortly summarized in the following sentence: "Stop smoking and keep walking".

[The Hickman catheter as vascular access in bone marrow transplantation]. / Il catetere di Hickman come accesso vascolare nel trapianto di midollo osseo.

From 1984 to 1995, 522 Hickman catheters were placed in the Institute of Clinica Chirurgica B of the University of Genova to treat malignant haemathologic diseases. Aims and reasons of this choice, surgical technique, advantages and related problems are reported here.

[Results with arteriovenous fistulae in periodic haemodialysis]. / L'impiego della fistola artero-venosa nel trattamento emodialitico periodico.

Personal experience regarding 92 arteriovenous fistuale carried for the application of the artificial kidney in 70 patients is described. The technical technique is explained and haemodynamic considerations in support of a preference for end-to-end anastomosis are illustrated. A critical assessment is made of the reasons for failure and their prognostic significance as far as subsequent operation is concerned.

[Intestinal transit time in bilio-pancreatic bypass]. / Il tempo di transito intestinale nel bypass bilio-pancreatico.

Transit times were evaluated in 23 obese subjects before and 1,4 and 12 months after biliopancreatic by-pass. A modified version of the method of Hinton et al. was used to determine emptying of the stomach and partial and total transit times. Emptying of the stomach was normal preoperatively. After surgery, it was almost immediate, except in two subjects with stomitis. Both transit times were virtually unchanged. Since the segment between the stomach and the ileocaecal valve is only half as long as in the normal subject, the results show that the by-pass leads to a slowing of transit that concerns the small intestine only, is quickly established, and does not change in the course of time. Evaluation of the altered anatomical and functional situation, and the absence of a correlation between the long-term behaviour of transit times on one hand and of lipid malabsorption and weight loss on the other-hand, suggest that a slower transit time must not be regarded as a compensation mechanism, except insofar as it restricts the degree of malabsorption set up immediately after surgery. Preliminary studies of enterohormonal changes following the by-pass indicate that increased glucagon and decreased motiline values are mainly responsible for slower transit times.

[2 cases of death caused by hepatic insufficiency after jejuno-ileal bypass for obesity]. / Su due casi di morte per insufficienza epatica dopo bypass digiuno-ileale per l'obesità.

Reference is made to 2 cases of fatal liver failure following jejuno-ileal by-pass for obesity, in which necropsy shown micronodular and the rarer fragmentary necrosis, in addition to serious steatosis. Liver alterations following by-pass are usually reversible and respond to the infusion of medicaments. The indication for surgical re-establishment of continuity, in which, if timely, leads to normalisation of liver shape and function, must be chosen without hesitation when changes, albeit reversible, appear to threaten life and resist treatment, and in all cases where biopsy points to progression towards irreversible sclerosis.

[Pre-operative identification of patients at risk for septic complications after surgery for neoplasms of the digestive system. A multiphasic multicenter study]. / Identificazione pre-operatoria del paziente "a rischio" di complicanze settiche dopo chirurgia per neoplasia dell'apparato digerente. Studio policentrico multifasico.

One hundred ninety-six patients undergoing surgical treatment for digestive tract cancer were recruited in a polycentric, multistep study to value significant differences of pre-operative nutritional and immunologic parameters between patients with or without post-operative infections. Such parameters might be useful for the identification of "septic risk" patients. Primarily, 63 patients were given a complete anthropometric evaluation, laboratory screening and immunologic assessment (surface marker analysis of peripheral blood mononuclear cells, polymorphonuclears in vitro chemotaxis and phagocytosis). Only a few serologic parameters were significantly reduced in patients with post-operative infections, namely: total serum proteins (p less than 0.02), albumin (p less than 0.02), beta-globulins (p less than 0.01), and C3c (p less than 0.05). These parameters were elaborated with Fisher's linear discriminant function to detect the optimal discriminant threshold able to identify "septic risk" patients. The predictivity of this discriminant function was validated in a second group of patients (n = 49) in which total serum protein with electrophoresis were pre-operatively assayed as well as skin test reactivity to intradermal injection of recall antigens (Multitest skin-testing); discriminant sensitivity was 80%, the specificity 50%, and positive predictivity 62%. This low discriminant power of the equation based only on serum proteins assessment coupled with the significant negative relationship between skin testing and post-operative infections (male, p less than 0.005; female, less than 0.025) suggested a re-elaboration of the discriminant function, including the skin-testing score. The definite assessment of this new discriminant equation was evaluated in the third sample of patients (n = 84) which showed 67% sensitivity, 88% specificity, and 76% positive predictivity, thus suggesting the high reliability of this test for the pre-operative selection of "septic risk" patients.

[Behavior of the serum electrolytes after jejuno-ileal bypass for obesity]. / Comportamento degli elettroliti serici dopo bypass digiuno-ileale per l'obesità.

Serum electrolytes, diarrhoea and absorption of bile salts were examined before and for one year after jejuno-ileal by-pass in 5 obese subjects. Marked decrease in blood potassium, calcium and magnesium was noted post-operatively, with potassium and calcium levels still well below the preoperative levels after 1 yr. Faecal volume increased considerably soon after operation, then fell to about 1 1/day in the first few months and changed little thereafter. Absorption of bile salts was seriously and lastingly compromised. In the light of the relevant literature, these results show that electrolyte imbalance, being closely linked to diarrhoea induced by bile salts, is an inevitable consequence of this operation and cannot be controlled by changing the surgical procedure.

[Distal gastrectomy with Y gastroenteroanastomosis not associated with vagotomy in elective surgical treatment of gastroduodenal ulcer. Clinical and functional long-term results]. / La gastrectomia distale con gastroenteroanastomosi a Y non associata a vagotomia nel trattamento chirurgico di elezione dell'ulcera gastroduodenale. Risultati clinici e funzionali a lungo termine.

During the period 1977-1984, 53 patients with peptic ulcer resistant to H2-blockers (29 gastric and 24 duodenal ulcers) were submitted to distal gastrectomy with Roux-en-Y gastroenteroanastomosis not associated with vagotomy. The indication was used as an alternative to proximal vagotomy in cases with delayed gastric emptying, high acid output, perforation or bleeding. The study plan consisted of serial clinical and instrumental controls including determination of basal (BAO) or maximal (MAO) acid output. Operative mortality was nil. At various times after the operation, 4 patients died for unrelated reasons and 3 were lost to follow-up. Median follow-up was 84 months with an interval of from 4 to 137 months. Fifty-one patients were followed up for at least one year and 49 for at least two. Five patients (2 gastric and 3 duodenal ulcers) developed peptic recurrences (Visick IV, 9.8%) by the end of the first postoperative year and, in all cases but one, healed stably by the second year after medical (3 cases) or surgical (1 case) therapy. In the remaining patients, Visick was grade III in 6 cases (4 gastric and 2 duodenal ulcers), grade II in 6 and grade I in 34. Before operation, mean values (+/- SD) of BAO and MAO were respectively 5.84 +/- 5.03 and 29.6 +/- 18.6 mEq/h. In the immediate postoperative period there was a considerable reduction in BAO (p less than 0.02) and MAO (p less than 0.03) which continued up to the third postoperative year with a tendency to further progressive reduction in MAO. In spite of a considerable individual variability in dimensions and temporal evolution, the phenomenon occurred qualitatively in all cases. No significant difference was observed in the behaviour of BAO and MAO in gastric ulcers by comparison with duodenal ulcers and in cases with recurrence and Visick III compared to those with a favourable clinical result.

[Hyperthermic-antiblastic isolation perfusion for advanced melanoma of the limbs. The technic, immediate results and a review of the literature]. / La perfusione isolata ipertermico-antiblastica per il melanoma avanzato degli arti. Tecnica, risultati immediati e revisione della letteratura.

Hyperthermic antiblastic isolated perfusion is a method largely used for the treatment of locally advanced limb melanoma. The method requires vascular isolation and hyperthermic perfusion of the limb using an extracorporeal circuit and administering the melphalan as antiblastic drug. Twenty-six patients with primary or recurrent melanoma of the limbs have undergone this treatment at our Institute. There were no cases of operative mortality and systemic toxicity was negligible. The local complications were transitory and no patient showed symptoms of nervous toxicity or permanent functional damage. Two cases of deep thrombophlebitis and two of lymphocele were documented a few months after treatment. Four clinically complete responses, 3 partial and 2 cases of stable disease were observed in the 9 patients treated with unexcised lesions. Our data like the totality of the present experience points to the safety of this method in the therapy of locally advanced limb melanoma. Nevertheless further controlled studies are required to define its role in order to improve survival.

[Behavior of serum proteins and lipids after jejuno-ileal bypass for obesity]. / Comportamento delle proteine e dei lipidi serici dopo bypass digiuno-ileale per l'obesità.

Variations in body weight, behaviour of lipidaemic fractions proteinaemia, uricaemia and uricuria, and lipid and protein absorption were studied preoperatively and at varying times following operation in five subjects who had undergone jejuno-ileal bypass for obesity. The results showed high serous NEFA and a definite, early and persistent reduction in all lipidaemic fractions after operation. The post-operative levels of serous proteins, particularly albumin, which were reduced in all subjects, reached pathological levels in two patients where proteic malnutrition following on the operation was associated with serious liver disease. The results agree with reported data. The variations in lipidic and proteic malabsorption proved to be in agreement with weight drop and the serous parameters considered. The reduction in uricaemia encountered in the five patients studied failed to agree with data reported in the Anglo-Saxon literature. This may be explained by alimentary and racial differences between the two populations of patients.

[Success in a case of fulminant hepatitis treated with extracorporeal liver perfusion and exchange transfusion]. / Successo in un caso di epatite fulminante trattato con perfusione di fegato extracorporeo ed exsanguinotrasfusione

Extracorporeal perfusion of pig liver lasting 4 hr, followed by isovolaemic exchange (6 litres in 1 hr) were employed in the management of coma in a case of acute virus hepatitis. Liver perfusion led to temporary regression of coma, whereas transfusion was followed by gradual improvement in the clinical picture; this was apparently not a direct consequence of the procedure adopted. Assessment of the degree of purification obtained with these two methods offers an explanation for the difference in their clinical effectiveness.