Strategic Encounters in Innovation and Regulation: Healthcare Transformation in the Era of Digital Connectivity Comment on "What Managers Find Important for Implementation of Innovations in the Healthcare Sector - Practice Through Six Management Perspectives".

Healthcare innovations emerge and develop in institutionally dense selective environments. New projects and propositions in healthcare sectoral ecosystems can be understood as product-service compacts, that is, complex solutions that dynamically integrate tangible and intangible elements in close interaction with users' needs and the evolving regulatory context under uncertainty and ambiguity. We advance the concept of "strategic encounters" to encapsulate, capitalise and extend the contribution by Palm and Fischier's on the key enabling managerial factors for healthcare innovation implementation under conditions of imperfect foresight. We intertwine creative assemblages that shape the formation of knowledge-intensive activities at the operators' level with scope of sectoral level interventions to underscore how the opportunities and constraints can enhance innovation for the common good. We use the case of digital data health regulatory agendas as illustration. We argue that this broader perspective on healthcare transformation is theoretically pertinent and practically useful, for management and policy.

[Therapy of asymptomatic gallstones: indications and limits]. / La terapia della calcolosi della colecisti asintomatica. Indicazioni e limiti.

Gallstone disease is one of the most common health problems world-wide. It is also one of the main causes of medical expenditure in Western countries. Asymptomatic gallstones are defined as stones that have not given rise to biliary cholic or other biliary symptoms. A number of epidemiological cross-sectional screening studies have shown that as many as 66 to 77% of patients with gallstones are asymptomatic. Opinion regarding the development of the disease in the asymptomatic patients has changed in the course of time. In 1992 Friedman, in his review of literature, established that only 1-2% of asymptomatic patients developed severe symptoms or complications early, with fewer complications developing in later years than in the years soon after discovery of the gallstones. Recent prospective epidemiological studies have established that no particular factor has any effect on the natural course of the disease. Laparoscopic cholecystectomy is the gold standard for symptomatic gallstones, but the management of patients with asymptomatic stones remains controversial. This problem is related to the incidence of biliary lesions which has remained substantially unchanged over the past few years. It has recently been demonstrated that the risk of iatrogenic lesions is not entirely dependent upon the surgeon's experience. There is a substantial consensus of agreement that surgical treatment has an unfavourable cost:benefit ratio in asymptomatic patients. The Authors conclude that, because of the condition's benign natural history, a wait-and-see policy is to be recommended in all asymptomatic patients, except for only a few selected cases.

[Laparoscopy in abdominal emergencies. Indications and limitations]. / La laparoscopia nelle urgenze addominali. Indicazioni e limiti.

Laparoscopy, which has been well known as a diagnostic procedure for more than a century, has recently established itself as an important therapeutic procedure in several branches of surgery. In the present study the authors report on 221 patients over a 10-year period (1991-2001), admitted to hospital with a diagnosis of acute abdomen or abdominal trauma. All patients were submitted to emergency laparoscopic surgery; 128 patients (57%) presented acute appendicitis, 40 (18%) acute cholecystitis, 13 (6%) occlusive ileus, 10 (5%) adnexal pathologies, 9 (4%) perforation of abdominal viscera, 3 (1.4%) acute diverticulitis, 3 (1.4%) subdiaphragmatic abscesses, 3 (1.4%) intestinal infarction, 2 (0.8%) other diseases and 10 (5%) abdominal trauma. The operation was completed laparoscopically in 192 cases (87%), while conversion to laparotomy proved necessary in 29 cases (13%). The morbidity of the cases completed laparoscopically was 3%, the mortality 0.5%, and the mean hospital stay 4 days. Advantages of laparoscopy (shorter hospital stay, rapid postoperative recovery and faster return to social activities) emerge from the present study and are confirmed by the literature. The possibility of combining a diagnostic procedure with curative therapy suggests that laparoscopy may have an important role in emergency surgery, demonstrating its efficacy also in acute abdominal syndromes. Nevertheless, emergency laparoscopic surgery is still a technically difficult procedure that needs to be performed by an expert surgical team.

["Sequential" treatment: is it the best alternative in cholecysto-choledochal lithiasis?]. / Il trattamento "sequenziale": la migliore delle alternative nella litiasi colecisto-coledocica?

Laparoscopic cholecystectomy has become the treatment of choice for patients with symptomatic cholelithiasis. About 10-20% of patients with gallbladder stones may also present associated common bile duct stones. The management of the latter remains controversial because many different surgical strategies are available: laparoscopic treatment (laparoscopic common bile duct exploration), sequential endoscopic and laparoscopic treatment (endoscopic retrograde cholangiopancreatography/endoscopic sphincterotomy [ERCP/ES] prior to laparoscopic cholecystectomy), inverted sequential endoscopic-laparoscopic treatment (laparoscopic cholecystectomy followed by ERCP/ES), and combined endoscopic-laparoscopic treatment (laparoscopic cholecystectomy with intraoperative ERCP/ES). The aim of this study was to evaluate the efficacy and safety of sequential endoscopic-laparoscopic treatment in patients with cholecystocholedocholithiasis. We retrospectively analyzed the clinical, biochemical and radiological features of 552 patients operated on for cholelithiasis from 1991 to 2001. Common bile duct stones were suspected on the basis of increased serum levels of bilirubin, GOT, GPT, GGT, alkaline phosphatase; presence of jaundice; history of pancreatitis or cholangitis; dilated common bile duct (diameter > 8 mm) or common bile duct stones at hepatobiliary ultrasonography; presence of common bile duct stones at MR-cholangiography or at i.v. cholangiography. In patients with suspected common bile duct stones, preoperative ERCP was performed; if common bile duct stones were confirmed, ES was performed. When common bile duct stones were not suspected preoperatively, laparoscopic cholecystectomy was performed directly. Overall morbidity, mortality and conversion rates in the two groups were evaluated. Of 552 patients admitted for cholelithiasis, 62 (11.3%) underwent preoperative ERCP for suspected common bile duct stones. In 41 patients (66.1%) common bile duct stones were identified and ES with common bile duct stone extraction was performed in 40 patients (clearance: 97.5%). The overall morbidity was 16% (10 cases of post-ERCP acute pancreatitis); no mortality occurred. The conversion rate during subsequent laparoscopic cholecystectomy was 4.8%. In the group of patients with no suspicion of common bile duct stones, the conversion rate was 4.9%. Sequential treatment cannot be considered the best approach for patients with cholecystocholedocholithiasis because of its morbidity rate and the high rate of negative preoperative ERCP findings. Combined endoscopic-laparoscopic treatment seems to present more advantages, especially in term of morbidity, hospital stay and patient compliance and may, in future, be considered the treatment of choice for patients with cholecystocholedocholithiasis.