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PubMed2004

Type of anaesthesia and patient acceptance in groin hernia repair: a multicentre randomised trial.

BACKGROUND: Groin hernia repair can be performed under general (GA), regional (RA), or local (LA) anaesthesia. This multicentre randomised trial evaluates patient acceptance, satisfaction, and quality of life with these three anaesthetic alternatives in hernia surgery. METHODS: One hundred and thirty-eight patients at three hospitals were randomised to one of three groups, GA, RA, or LA. Upon discharge, they were asked to complete a specially designed questionnaire with items focusing on pain, discomfort, recovery, and overall satisfaction with the anaesthetic method used. The global quality-of-life instrument EuroQol was used for estimation of health perceived. RESULTS: Significantly more patients in the LA group than in the RA group felt pain during surgery ( P<0.001). This pain was characterised as light or moderate and for the majority of LA patients was felt during infiltration of the anaesthetic agent. Postoperatively, patients in the LA group first felt pain significantly later than patients in the other two groups ( P=0.012) and significantly fewer LA patients consumed analgesics more than three times during the first postoperative day ( P=0.002). The results concerning nausea, vomiting, and time to first meal all favour LA. No difference was found among the three groups concerning overall satisfaction and quality of life. CONCLUSION: In a general surgical setting, we found LA to be well tolerated and associated with significant advantages compared to GA and RA.

Adult↗

PubMed2006

Open, preperitoneal hernia repair with the Kugel patch: a prospective, multicentre study of 450 repairs.

BACKGROUND: The Kugel patch inguinal hernia repair is a relatively new, open, minimally invasive procedure using a preperitoneal approach. METHOD: Prospective multicentre case series of 450 consecutive Kugel patch repairs. Recurrence rates and persistent inguinal pain after at least 1 year as well as short-term outcomes were studied. RESULTS: After a follow-up of 18 months, eight recurrences (1.9%) were found, and persisting inguinal pain was reported in 15 patients (3.5%). The mean operation time and hospital stay were 20 +/- 9 min and 19 +/- 1.3 h respectively. Less than 1% of patients planned for an ambulatory treatment needed prolonged hospitalisation. Analgesics were used for 3 +/- 2 days. Paracetamol was the only painkiller used in 69% of patients, and 13% did not take any painkiller at all. Half of all patients returned to their daily activities after 9 days and half of the employed patients returned to work after 14 days. CONCLUSION: The Kugel patch repair is a quick technique with a low recurrence rate and good patient comfort. It offers the advantages of a preperitoneal inguinal hernia repair without the need for general anaesthesia or expensive laparoscopic equipment.

Adult↗

PubMed2003

A double-blind, multicentre, randomised clinical trial comparing the efficacy and tolerability of aceclofenac with diclofenac resinate in patients with acute low back pain.

The efficacy and tolerability of aceclofenac was compared with diclofenac resinate in a double-blind, multicentre randomised study in patients with acute low back pain suffering from degenerative spinal disorders. The study included 227 patients randomised to receive either aceclofenac 2 x 100 mg daily or diclofenac resinate 2 x 75 mg daily for up to 10 days. The primary objective was to demonstrate the clinical non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate, as assessed by changes from baseline in the visual analogue scale (0-100 mm) pain score, at rest and at visit 3 (final visit on day's 8-10). Secondary objectives included the time to early cure (resolution of pain) and global assessment of tolerability. Mean change in pain score at rest, and as visit 3, compared with baseline, was 61.6 mm (SD 24.5) for the aceclofenac group ( n = 100) and 57.3 mm (SD 22.8) for the diclofenac resinate group ( n = 105) in the per-protocol population. Similar changes were observed in the intention-to-treat population. Between-group differences of 4.5 mm and 5.5 mm for the per-protocol and intention-to-treat populations, respectively, demonstrated clinical non-inferiority of aceclofenac compared with diclofenac resinate. Furthermore, there was evidence for superiority of aceclofenac over diclofenac resinate in terms of statistical significance, as the one-sided 97.5% confidence interval was above -10 mm and 0 mm. In the intention-to treat population, a total of six aceclofenac-treated patients discontinued their medication owing to early cure, compared with only one patient receiving diclofenac resinate. Seventeen aceclofenac- (14.9%), and 18 diclofenac resinate-treated patients (15.9%) reported at least one adverse event. However, the total number of adverse events reported was lower in patients receiving aceclofenac (22 versus 31 in the diclofenac resinate group). In conclusion, non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate was demonstrated in patients with localised, uncomplicated acute lumbosacral pain. For the reduction in pain levels from baseline there was also evidence for superiority of aceclofenac compared with diclofenac resinate in terms of statistical significance, although this difference was not considered clinically relevant. The results also showed a trend towards a better safety and tolerability profile of aceclofenac over diclofenac resinate from a clinical point of view.

Acute Disease↗

PubMed2003

Systemic juvenile idiopathic arthritis mimics multicentric Castleman's disease.

An 11-year-old girl presented with fever and a large cervical lymphadenopathy. Indicators of inflammation were remarkable: she had extremely high levels of serum interleukin-6 (IL-6) (398 pg/ml) in addition to hypergammaglobulinemia and hypoalbuminemia. Computed tomography (CT) revealed swollen systemic lymph nodes. Two weeks after the onset of symptoms she developed polyarthralgia. Biopsy of the cervical lymph node revealed massive infiltration of plasma cells without hyaline vascular changes. She was diagnosed with systemic juvenile idiopathic arthritis (JIA). The patient's symptoms and hypercytokinemia disappeared soon after corticosteroid treatment was started. This case demonstrates that overproduction of IL-6 is common to systemic JIA and multicentric Castleman's disease.

Arthritis, Juvenile↗

PubMed2006

Durable remission of HIV-negative, Kaposi's sarcoma herpes virus-associated multicentric Castleman disease in patient with rheumatoid arthritis treated with methotrexate.

Multicentric Castleman disease (MCD) is a nonneoplastic lymphoproliferative disorder that has a poor prognosis. Optimal treatment is unknown. There are a few reported cases of MCD and rheumatoid arthritis. In this study, we report a patient with rheumatoid arthritis diagnosed with Kaposi's sarcoma herpesvirus-(KSHV, human herpesvirus-8) associated MCD that showed expression of viral IL-6. Treatment with methotrexate (MTX) resulted in a complete remission of her disease lasting for 54+ months. Multiple studies have suggested that MCD and rheumatoid arthritis are associated with overexpression of the growth-promoting cytokine interleukin-6 (IL-6), and that MTX downregulates the production of this cytokine in vivo. As such, we suggest that the dramatic improvement in this patient's disease is due to the immunomodulatory properties of MTX.

Aged↗

PubMed2004

The role of neuroimaging in the diagnosis of headache in childhood and adolescence: a multicentre study.

Following the diagnostic indications of the Guidelines for the diagnosis and therapy of juvenile headache, we present the results of a prospective, multicentre study of headache patients aimed at evaluating the utility of neuroradiologic testing in the diagnosis of headache. A total of 6535 subjects up to age 18 were studied, and 1485 underwent neuroimaging testing based on the indications of the diagnostic Flow-Chart. Abnormal results were observed in 273 (18.5%) subjects. Incidental findings were observed in 138 (9.3%) subjects, not correlated with the headache pathology, whereas alterations that led to the diagnosis of secondary headache were observed in 135 (9.1%) subjects. In conclusion, our data support a greater incidence of positive neuroimaging examinations among patients who underwent testing based on suspicion of a secondary headache pathology when compared with the low percentages observed in study populations.

Adolescent↗

PubMed2004

Does headache represent a clinical marker in early diagnosis of cerebral venous thrombosis? A prospective multicentric study.

The main aim of this study is to look for early clinical markers of cerebral venous thrombosis (CVT). As headache represents the major clinical manifestation at presentation we focused our attention on this symptom. We present the preliminary results of a prospective multicentric study that includes cases diagnosed as CVT in the participating centres. We have so far studied 35 patients (5 males and 30 females) from the ages of 18 to 78. The most frequent manifestation was headache (77.1%). It was more frequently localised (66.7%) and continuous (77.8%). The onset of pain was mostly acute-subacute (38.5%-50.0%) and the intensity moderate-severe (37.0%-51.9%). On univariate analysis, we found a positive correlation between CVT, acute headache onset (p=0.001) and severe headache (p=0.004). These preliminary results seem in accordance with our previous findings in the retrospective study, suggesting that CVT is more often associated with acute-onset headache of severe intensity.

Acute Disease↗

PubMed2005

A multicentre prospective collection of newly diagnosed glioblastoma patients in Lombardia, Italy.

The objective was to set the basis for a prospective, multicentre data collection on newly diagnosed adult glioblastoma patients diagnosed in Lombardia by means of a common database used by neurological and neurosurgical units of various hospitals, providing epidemiological, therapy and follow-up data. All adult patients with a newly diagnosed glioblastoma in 9 Lombardia hospitals from 31 March 2003 to 31 March 2004 were followed prospectively by a form elaborated by the Lombardia Neuro-oncology Group. Demographic data were recorded, as well as symptoms at onset, entity of tumour resection, post-surgical Karnofsky Performance Score, radio- and chemotherapy, presence/absence of venous thrombosis, type of antiepileptic treatment, time to tumour progression and survival time (ST). One hundred and thirty-four newly diagnosed glioblastoma patients were enrolled during the first year of the study. Male/female ratio was 1.6:1. Median age was 61 years. The most common single sign/symptom at disease onset included seizures, followed by mood/cognition changes and headache. In 71 patients, the tumour involved 1 brain lobe at diagnosis. Twenty-five patients underwent biopsy, 51 partial removal and 51 grossly total removal. At analysis of predictive value on ST, grossly total resection and chemotherapy were significantly associated with a longer ST. Age younger than 50 showed a trend to predictive value. A very high proportion of patients were treated with antiepileptic drugs, even in the absence of seizures. Median ST was 12 months in our cohort. Data in newly diagnosed glioblastoma patients in Lombardia are in line with other case series reported in other populations.

Adult↗

PubMed2006

Tumour-associated epilepsy: clinical impact and the role of referring centres in a cohort of glioblastoma patients. A multicentre study from the Lombardia Neurooncology Group.

Epilepsy in high-grade glioma patients is a major concern, mainly as regards indications to treatment and best choice; toxicities, and pharmocokinetic and pharmacodynamic interactions of drugs. All these generally unsolved problems complicate patients' quality of life and interfere with the evaluation of response criteria in clinical trials. A prospective, multicentre data collection on 132 adult newly diagnosed, histologically proven glioblastomas from 9 Lombardy hospitals collected in the same database during a one-year period was recently published. From this database we report epidemiological and clinical characteristics in epilepsy-symptomatic (31%) glioblastoma patients vs. the group with other presenting symptoms (69%). We analyse demographic and clinico-radiological features, timing of onset and the course of seizures, and modalities of treatment in the two groups of patients. No statistically significant differences were observed between the two groups as regards age, site of lesion(s), extent of surgery and survival in relation to anticonvulsant treatment status or pharmacokinetic properties of drugs.

Adult↗

PubMed2006

Variables influencing quality of life and disability in Charcot Marie Tooth (CMT) patients: Italian multicentre study.

The purpose of this study was to assess the variables that influence quality of life (QoL) and disability in patients with Charcot-Marie-Tooth disease (CMT). We performed a prospective multicentre study using validated clinical disability and QoL measurements. Multivariate analysis was performed using QoL as a dependent variable and duration of symptoms, age, gender and CMT type, depression and disability measurements as independent variables. We enrolled 211 patients. QoL was highly significantly deteriorated with respect to the Italian normative sample. The physical aspect of QoL was mainly related to disability but it does not increase with the age, probably because of an adaptation between expectation and reality. The mental QoL is influenced by depression (hence we have to consider this aspect approaching CMT patients). Moreover, we observed that women complained of more severe symptoms than men. Finally, some CMT subtypes are related to more severe bodily pain symptoms than others. Multiperspective assessment of CMT showed new aspects of this disease, mainly regarding (1) differences between men and women and (2) the crucial role of pain and depression.

Adolescent↗

PubMed1999

Italian multicentre study of carpal tunnel syndrome: clinical-neurophysiological picture and diagnostic pathway in 461 patients and differences between the populations enrolled in the northern, central and southern centres. Italian CTS Study Group.

The economic trend in our country, as in other countries, now requires us to pay more attention to the social and economic aspects of health. Therefore, it is important to evaluate the diagnostic pathway and the socioeconomic aspects of pathologies. The Italian CTS Study Group performed a wide multicentre and multidimensional study (through a patient-, physician- and neurophysiologically oriented evaluation) on 461 idiopathic CTS patients to evaluate the clinical-neurophysiological picture and the diagnostic pathway. The whole population and the differences between the populations enrolled in the neurophysiological centres of the northern, central and southern parts of Italy were analysed. This study provided new and interesting information. As concerns the whole population, we observed different diagnostic pathways in relation to the level of schooling. As concerns the comparison of the populations, the southern centres have a population of CTS patients with higher frequency of hand stress and more severe nerve impairment.

Adult↗

PubMed2000

Guillain-Barré syndrome: an Italian multicentre case-control study. Guillain-Barré Syndrome Study Group.

Various diseases are described as antecedents of Guillain-Barré syndrome (GBS), particularly gastroenteritis and respiratory infectious diseases, but epidemiological surveys are rare. This paper details a multicentre matched case-control study carried out within a well-defined Italian population. For each GBS case fulfilling the Asbury and Cornblath criteria, one control was recruited from a neurological (NC) ward and another from a non-neurological (NNC) ward, matched for age, sex, season of disease onset and area of residence. All cases and controls were administered a semistructured questionnaire. The OR was calculated according to the Mantel-Haenszel equation for triplets. Between 1 October 1996 and 30 September 1998, 75 triplets were included in the case-control study. The OR for flu-like syndrome was 7.14 (CI 95%, 3.28-15.52) and for gastroenteritis 3.57 (CI 95%, 1.31-9.72); no other factor reached significance. Our results, based on the clinical and anamnestic features of triplets of patients, support the possible role as risk factors for GBS of infectious diseases, particularly flu-like syndrome and gastroenteritis.

Adolescent↗

PubMed2026

Evolution of Candidaemia and azole resistance in Italy: A multicentre retrospective study.

PURPOSE: Candidaemia is the most common healthcare-associated invasive fungal infection. The evolution of the epidemiology of candidaemia in Italy has not been assessed, except at the local level. The primary objective of this study is monitoring changes in the epidemiology of candidaemia and in the susceptibility profiles of Candida isolates between 2015 and 2023. METHODS: This retrospective multicentre study (2015-2023), involved 11 tertiary-care hospital microbiology laboratories across the Italian country. The confirmed candidaemia episodes were included and demographic data, hospital ward, species identification, and antifungal susceptibility profiles (Sensititre Yeast One) were collected. RESULTS: 6,927 candidaemia cases were identified; incidence increased from 1.1/1000 hospitalisations in 2017 to 2.3/1000 in 2020-2021, peaking during the COVID-19 pandemic, and declined in 2023 while remaining above prepandemic levels. Patients older than 65 years accounted for most infections. Medical wards represented the main setting of occurrence, followed by intensive care units, especially during pandemic years. C. albicans remained the most common species (45.4%), followed by C. parapsilosis (24.7%), C. glabrata (11.8%), and C. tropicalis (11.4%). Echinocandin resistance remained low (< 2% for C. albicans and C. glabrata), whereas azole resistance increased markedly, particularly in C. parapsilosis, reaching fluconazole resistance rates of 25.6% in 2022. CONCLUSIONS: Candidaemia increased during the 9-year study period in Italy, particularly in the COVID-19 pandemic, in medical wards and ICU. Emerged a growing azole resistance, underscoring the need for enhanced surveillance and informed empirical treatment strategies.

Candida species etiology↗

PubMed2026

Moraxella species isolated from blood cultures in Europe (MORAXEu): a multicentre study of epidemiology and antimicrobial susceptibility with complementary phylogenomic analysis of publicly available genomes.

INTRODUCTION: Moraxella species are fastidious Gram-negative bacteria capable of causing opportunistic infections, including bloodstream infections, especially in immunocompromised patients. Data on their epidemiology, antimicrobial susceptibility, and phylogenomics in Europe remains limited. METHODS: We conducted a multicentre, retrospective, observational study across 56 European hospital centres between January 1st 2020 and December 31st 2024. All Moraxella species isolated from blood cultures (BCs) were included. Species distribution and antimicrobial susceptibility profiles were analysed. We also performed a phylogenomic analysis of Moraxella genomes deposited in GenBank. RESULTS: A total of 709 Moraxella isolates were included. Moraxella osloensis (61.1%; n = 433/709) and Moraxella catarrhalis (20.4%; n = 145/709) were the most frequently identified species, followed by Moraxella nonliquefaciens (6.5%; n = 46/709) and Moraxella atlantae (4.8%; n = 34/709). Species distribution differed by age. M. catarrhalis was predominant in paediatric patients, whereas M. atlantae was more common in adults. Most isolates showed > 90% susceptibility to amoxicillin/clavulanate, cefotaxime, fluoroquinolones, and trimethoprim/sulfamethoxazole. Cefotaxime resistance in M. osloensis was more frequent in adults than in children (49% vs. 8%, p = 0.009). Phylogenomic analysis demonstrated the distinction of a core Moraxella group from the divergent Faucicola lineage, with M. osloensis and M. atlantae clustering within the latter. CONCLUSIONS: The epidemiology of Moraxella species from BCs in Europe showed age-group-specific differences in species distribution and generally favourable antimicrobial susceptibility patterns. Phylogenomic data corroborated recent taxonomic revisions, highlighting the need for improved diagnostics, harmonized nomenclature and sustained surveillance to inform management and stewardship of Moraxella bacteraemia.

Faucicola↗

PubMed2001

European multicentre survey of in vitro antimicrobial resistance in Helicobacter pylori.

A multicentre in vitro survey was carried out in 1998 in 22 European centres in order to assess the variation in the prevalence of Helicobacter pylori resistance. The susceptibility of 1,274 isolates to metronidazole, clarithromycin and amoxicillin was determined by the E test. The mean rate of resistance to metronidazole was 33.1% (95% CI, 7.5-58.9), to clarithromycin 9.9% (95% CI, 0-28.1) and to amoxicillin 0.8% (95% CI, 0-8.9). Resistance to metronidazole was significantly higher in females (P<0.001), while resistance to clarithromycin was significantly higher in children and teens (P<0.05). Resistance to both agents also tended to be higher in strains isolated from patients from southern European countries than in those isolated from patients from central or northern Europe. Overall, these results emphasize the need for further surveys of Helicobacter pylori sensitivity to antibiotics at a national and regional level.

Amoxicillin↗

PubMed2003

Efficacy of low-level laser therapy in the management of stage III decubitus ulcers: a prospective, observer-blinded multicentre randomised clinical trial.

Low-level laser therapy (LLLT) has been suggested as a promising treatment option for open wounds. In view of the absence of randomised studies with sufficiently large sample sizes, we assessed the efficacy of LLLT in the treatment of stage III decubitus ulcers. We performed a prospective, observer-blinded multicentre randomised clinical trial to assess the effect of LLLT as adjuvant to standard decubitus care. A total of 86 patients were enrolled into the study. Treatment was the prevailing consensus decubitus treatment (n=47); one group (n=39) had LLLT in addition, five times a week over a period of 6 weeks. The primary outcome measure was the absolute (mm2) and relative (%) wound size reduction at 6 weeks compared to baseline. Secondary outcome measures were the number of patients developing a stage IV ulcer during the study period, and the median change in Norton scores at 6 weeks compared to baseline. Based on the intention-to-treat principle, using last-observation-carried-forward analyses, Mann-Whitney U tests showed that the differences between the two groups in terms of absolute improvement (p=0.23) and relative improvement (p=0.42) were not significant. Because the wound size areas were non-normally distributed, we also analysed the data after logarithmic transformation of the wound size measurements. No significant difference in log(e) improvement scores between groups could be demonstrated (unpaired t-test: p=0.59). During the treatment period 11% of the patients in the control group and 8% of the patients in the LLLT group developed a stage IV decubitus ulcer (Fisher's exact test: p=0.72). The patients' Norton scores did not change during the treatment period. In this trial we found no evidence that justifies using low-level laser therapy as an adjuvant to the consensus decubitus ulcer treatment.

Aged↗

PubMed2004

Complications in laparoscopic colorectal surgery: results of a multicentre trial.

BACKGROUND: We present a prospective observational multicentre study of 4834 consecutive cases undergoing laparoscopic colorectal procedures. METHODS: The study was initiated on 1 August 1995, with centres from Germany, Austria and Switzerland participating. All patients undergoing laparoscopic colorectal surgery were included, and no selection criteria were applied. RESULTS: Between August 1995 and April 2004, the participating centres treated 4834 patients. Three thousand, one hundred and sixty-six operations were performed for benign indications, and 1668 for cancer, with most operations being done for diverticulitis (2019, 41.8%). The conversion rate was 5.6%, and the overall morbidity was 20.1%. Intra-operative complications occurred in 5.9%, postoperative complications in 14.0%, and the overall anastomotic leak rate was 3.1% (colon 2.6%, rectum 11.9%). The 30-day mortality rate was 1.3%. CONCLUSIONS: It has been our experience that laparoscopic surgery for colorectal disease is safe. Morbidity and mortality are comparable to those of conventional colorectal surgery.

Adolescent↗

PubMed2001

Which surgical approach for rectocele? A multicentric report from Italian coloproctologists.

The most effective surgical technique for rectocele has not yet been clearly established. A retrospective multicentric study was carried out to compare the long-term results of 3 endorectal techniques (Block, Sarles and stapled) and the perineal levatorplasty, alone and in association, in a series of patients with symptomatic rectocele. From January 1992 to December 1999, 2212 patients with defecation disorders were referred to 5 Italian coloproctology units. An anterior rectocele was clinically diagnosed in 1045 patients and confirmed with defecography. On the basis of clinical and radiological parameters, 317 patients (312 women; mean age, 52.4+/-20.1 years) were selected for surgery. Group 1 consisted of 141 patients (136 women; mean age, 50.4+/-18.8 years) who were submitted to endorectal operations. Group 2 consisted of 126 women (mean age, 52.5+/-19.7 years) who received perineal levatorplasty. Finally, 50 women (mean age, 54.3+/-21.9 years) in Group 3 received endorectal operations associated with perineal levatorplasty. A total of 269 patients were followed postoperatively (mean period, 24.2+/-3.1 months, 27.5+/-5.4 months and, 22.8+/-2.8 months, respectively) with the same questionnaire and clinical examination. Three months after surgery, a defecography examination and anorectal manometry were performed in 136 and 132 patients, respectively. Operative time, hospital stay and time to return to work were significantly higher in Group 3 (p<0.001). There was one death in Group 3 due to severe sepsis. Main postoperative complications were: in Group 1, hemorrhage (7.8%, all Sarles), dehiscence of the endorectal suture (5.0%, all Block), distal rectal stenosis (2.1%, 1 stapled, 2 block), and rectovaginal fistula (1.4%, all Sarles); in Group 2, delayed healing of the perineal wound (16.4%); in Group 3 delayed healing of the perineal wound (22.0%), hemorrhage (6%, all Sarles), dehiscence (4.0%), stenosis (2.0%). 17.3% of patients of Group 2 and 22.5% of Group 3 complained of dyspareunia. Postoperative defecography showed a complete absence of the rectocele in 44.1% of patients and reduction of size in the others, without significant differences among the three groups. Manometric pattern was not significantly modified by surgery. Significant symptoms recurred in 5.9% of the patients in Group 1, 6.4% in Group 2, and 5.0% in Group 3. Perineal levatorplasty did not significantly improve obstructed defecation, as it did not allow to excise the rectal mucosal prolapse, and was followed by an high incidence of delayed healing of the perineal wound and dyspareunia. Sarles procedure achieved better control of mucosal prolapse but carried a higher complication rate compared to the others. The association of the perineal levatorplasty with an endorectal technique required significantly longer operative time, and led to a longer hospital stay and time to return to work. In conclusion, the investigated techniques showed different patterns of postoperative complications: bleeding after Sarles, dehiscence after Block, dyspareunia after perineoplasty and fatal gangrene after stapled, but non of them showed a clear superiority over the others in term of clinical or functional results 2 years after surgery.

Adult↗