Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial.

Background: There are several methods used to extract common bile duct (CBD) stones encountered during cholecystectomy. Intraoperative cholangiotomy, cholangioscopy, and laparoscopic CBD exploration (LCBDE) are techniques that allow removal of stones from the CBD during the index procedure. However, bile leakage following CBD exploration is a common problem. The aim of this study was to assess whether fibrin sealant applied to the duct incision is safe. Methods: Patients planned for laparoscopic gallstone surgery at the Department of Surgery, Enköping Hospital, were included in the study. In cases where perioperative cholangiography showed CBD stones, LCBDE was performed through a longitudinal incision in the CBD. Randomization between closure of the incision with polyglactin sutures or with fibrin sealant was performed. After all the stones had been removed and the incision closed according to the allocation, an abdominal drain was placed close to the incision. A T tube was placed in the CBD or a straight tube into cystic duct for eventual postoperative cholangiogram. The patient and the surgeon assessing the postoperative course were blinded to the randomized allocation. Results: Altogether 51 patients were included from December 2012 to July 2016. Mean operative time was 188 minutes in the fibrin sealant group and 214 minutes in the suture group (P = .159). There was no significant difference between groups in bile flow in the abdominal drainage tube or in the CBD drain during the three first postoperative days. The time to removal of the abdominal drain did not differ significantly between groups. Conclusion: Although the present study lacks the statistical power to prove a benefit from fibrin sealant, it indicates that closure of the incision may be an option to reduce the risk for leakage. Further studies are required to confirm this. The study was retrospectively registered on clinicaltrials.gov September 5, 2015 (NCT02545153).

Management of Common Bile Duct Stones Encountered During Cholecystectomy in Patients With Previous Gastric Bypass.

Background: Rapid weight loss following gastric bypass (GBP) predisposes to the development of gallstones, and in those who develop gallstone disease there is a high prevalence of common bile duct stones (CBDS). Furthermore, in these patients, CBDS are difficult to extract due to the altered upper gastrointestinal anatomy following GBP. The aim of the present study was to assess outcome after various management methods applied in the counties of Stockholm and Uppsala, Sweden. Methods: Data from the Swedish Register for Gallstone Surgery and ERCP (GallRiks) and the Swedish Obesity Surgery Register (SoReg) were crossmatched to identify all patients who had undergone gallstone surgery after GBP, where CBDS were found at intraoperative cholangiography, in the Stockholm and Uppsala counties 2009-2013. A retrospective review of patient records was performed for all patients identified. Results: In all, 55 patients were identified. These were managed as follows: expectancy (N = 11); transgastric ERCP (N = 2); laparoscopic choledochotomy (N = 3); open choledochotomy (N = 5); transcystic stone extraction (N = 12); and other approach (N = 13). In nine cases, data on management could not be found. There were nine cases of minor postoperative complication. No retained stones were registered. The operation time was longer for transgastric ERCP (p = 0.002), and the postoperative stay was longer following open and laparoscopic choledochotomy (p < 0.001). There was no statistically significant difference between any of the methods regarding the incidence of postoperative complications (p = 0.098). Discussion: Further development of techniques for managing CBDS discovered in patients undergoing cholecystectomy after previous GBP are needed, as well as more comparative studies with greater statistical power.

Disparities in the regional, hospital and individual levels of antibiotic use in gallstone surgery in Sweden.

BACKGROUND: Antimicrobial resistance may be promoted by divergent routines and lack of conformity in antibiotic treatment, especially regarding the practice of antibiotic prophylaxis. The aim of the present study was to assess differences in gallstone surgery regarding antibiotic use in Sweden. METHODS: The study was based on data from the Swedish Register for Gallstone Surgery and ERCP (GallRiks) 2005-2015. Funnel plots were used to test impact of grouping factors, including, hospital and surgeon and to identify units that deviated from the rest of the population. RESULTS: After adjusting for cofounders including age, gender, ASA classification, indication for surgery, operation time, gallbladder perforation and emergency status, there were 0/21 (0%) at the regional level, 18/76 (24%) at the hospital level and 128/1038 (12%) at the surgeon level outside the 99.9% confidence interval (CI). The estimated median odds ratios were 1.13 (95% CI 1.00-1.31) at the regional level, 1.93 (95% CI 1.70-2.19) at the hospital level and 2.38 (95% CI 2.26-2.50) at the surgeon level. CONCLUSION: There are significant differences between hospitals and surgeons, but little or no differences between regions. These deviations confirm the lack of standardization in regards to prescription of antibiotic prophylaxis and the need more uniform routines regarding antibiotic usage. Randomized controlled trials and large population-based studies are necessary to assess assessing the effectiveness and safety of antibiotic prophylaxis in gallstone surgery.

Laparoscopic Common Bile Duct Exploration: 9 Years Experience from a Single Center.

INTRODUCTION: The aim of the study was to evaluate the safety and feasibility of laparoscopic common bile duct exploration (LCBDE) through cholangiotomy with T-tube placement in one séance for common bile duct stones (CBDS). METHODS: Between January 2005 and December 2010, a total of 99 patients with CBDS stones undergoing LCBDE with T-tube insertion at Enköping Hospital, Sweden, were registered prospectively. All patients were followed up by review of the patient records according to a standardized protocol. RESULTS: No severe intraoperative complications were registered. Four procedures required conversion to open cholecystectomy due to impacted stones or technical difficulty. The mean operative time was 194 min [(SD) 57 min]. The mean postoperative hospital stay was 4.8 days, SD 2.4 days. At secondary cholangiography, 2 (2%) retained stones were found. Two (2%) patients had minor bile leakage, which resolved spontaneously. None of the patients experienced biliary peritonitis, biliary fistula, pancreatitis, or cholangitis. No death within 30 days after surgery was seen. No patient was readmitted with clinical signs of stricture. CONCLUSION: If performed by a surgeon familiar with the technique, LCBDE is a safe and feasible alternative for managing CBDS. The advantages are most pronounced in the case of multiple and large CBDS. The risk for retained stones and stricture is low.

Best practice in placement of percutaneous endoscopic gastrostomy with jejunal extension tube for continuous infusion of levodopa carbidopa intestinal gel in the treatment of selected patients with Parkinson's disease in the Nordic region.

OBJECTIVE: Continuous infusion of levodopa carbidopa intestinal gel (LCIG) is associated with a significant improvement in the symptoms and quality of life of selected patients with advanced Parkinson's disease. Percutaneous endoscopic gastrostomy with jejunal extension (PEG/J) was first described in 1998 and has become the most common and standard technique for fixing the tubing in place for LCIG infusion. MATERIAL AND METHODS: A workshop was held in Stockholm, Sweden, to discuss the PEG/J placement for the delivery of LCIG in Parkinson's disease patients with the primary goal of providing guidance on best practice for the Nordic countries. RESULTS: Suggested procedures for preparation of patients for PEG/J placement, aftercare, troubleshooting and redo-procedures for use in the Nordic region are described and discussed. CONCLUSIONS: LCIG treatment administered through PEG/J-tubes gives a significant increase in quality of life for selected patients with advanced Parkinson's disease. Although minor complications are common, serious complications are infrequent, and the tube insertion procedures have a good safety record. Further development of delivery systems and evaluation of approaches designed to reduce the demand for redo endoscopy are required.

Level-adjusted funnel plots based on predicted marginal expectations: an application to prophylactic antibiotics in gallstone surgery.

Funnel plots are widely used to visualize grouped data, for example, in institutional comparison. This paper extends the concept to a multi-level setting, displaying one level at a time, adjusted for the other levels, as well as for covariates at all levels. These level-adjusted funnel plots are based on a Markov chain Monte Carlo fit of a random effects model, translating the estimated model parameters to predicted marginal expectations. Working within the estimation framework, we accommodate outlying institutions using heavy-tailed random effects distributions. We also develop computer-efficient methods to compute predicted probabilities in the case of dichotomous outcome data and various random effect distributions. We apply the method to a data set on prophylactic antibiotics in gallstone surgery.

Biliary microflora in patients undergoing cholecystectomy.

BACKGROUND: The management of acute cholecystitis requires a sound knowledge of the biliary microflora. METHODS: Bile samples were taken for culture according to a standard routine during all cholecystectomies performed from April 2007 to February 2009 in the Department of Surgery at Enköping Hospital. The use of antibiotics within the 3-mo period before surgery, indication for surgery, prophylactic antibiotics, and post-operative complications were recorded prospectively. RESULTS: Altogether, 246 procedures were performed during the study period, of which 149 (62%) were done on women. The mean (±SD) age of the study subjects was 49±16 y. Bacterial growth was seen in cultures from 34 (14%) of the subjects. The mean age of subjects with positive cultures was 64 y and that of subjects with negative cultures was 47 y (p<0.001). Positive culture was seen in 16 (31%) of the 51 patients who underwent operations for acute cholecystitis, whereas positive cultures were obtained in 18 of 195 patients without acute cholecystitis (9%) (p<0.001). Resistance to ampicillin was recorded in three of 34 (9%) of the cultures with bacterial growth, to co-trimoxazole in one of the 34 (3%) cultures, to fluoroquinolones in one of the 34 (3%) cultures, and to cephalosporins in one of the 34 (3%) cultures. Resistance to piperacillin-tazobactam was not observed in any of the cultures. In multivariable logistic regression analysis, a positive culture was the only factor significantly associated with risk for post-operative infectious complications (p<0.05). DISCUSSION: Bacterial growth in the bile is observed more often in patients undergoing surgery for acute cholecystitis. The microflora of the bile is probably important for the outcome of surgery, but further studies are required for assessing the effectiveness of measures for preventing infectious post-operative complications.

Effectiveness of antibiotic prophylaxis in cholecystectomy: a prospective population-based study of 1171 cholecystectomies.

BACKGROUND: The aim of this study was to assess the benefit from antibiotic prophylaxis (AP) during cholecystectomy in a population-based cohort study. METHODS: All cholecystectomies performed in Uppsala County, 2003-2005, were registered prospectively according to a standardized protocol. High-risk procedures (HP) were defined as operations for acute cholecystitis and procedures including exploration of the common bile duct. Infections requiring surgical or percutaneous drainage and non-surgical infections that prolonged hospital stay were defined as major infectious complications (IC). RESULTS: Altogether 1171 patients underwent cholecystectomy. AP was given to 130 of 867 (15%) of the patients undergoing low-risk procedures (LP) and 205 of 304 (67%) of those undergoing H-R P. Major IC were seen in 6 of 205 (3%) of the patients undergoing H-R P with AP and 1 of 99 of the patients undergoing H-R P without AP. No major IC was seen after L-R P. Minor IC were seen after 5 of 205 (2%) HP with AP, 1 of 99 (1%) HP without AP, 0 of 130 (0%) LP with AP, and 2 of 737 (0.3%) LP without AP. In univariate logistic analysis, the overall risk for IC was found to be higher with AP (p < 0.05), but the increase did not remain significant if adjusting for age, gender, ASA class, H-R P/L-R P and surgical approach or limiting the analysis to major IC. CONCLUSION: There is no benefit from AP in uncomplicated procedures. The effectiveness of antibiotic prophylaxis in complicated cholecystectomy must be evaluated in randomized controlled trials.

Validation of Gastrointestinal Quality of Life Index in Swedish for assessing the impact of gallstones on health-related quality of life.

OBJECTIVE: The aim of the present study was to validate a Swedish translation of the Gastrointestinal Quality of Life Index (GIQLI) questionnaire in patients with gallstone disease. METHODS: Sensitivity to change, internal consistency, and test-retest stability were tested in 187 consecutive patients who underwent planned cholecystectomy. Construct validity was assessed by comparing the GIQLI score with the bodily pain scale of SF-36 and four single-item questions in a separate group of 104 patients. RESULTS: A significant increase in all five domains as well as in the overall GIQLI score 6 months after surgery (all P < 0.05) was seen. All five domains correlated significantly with other measures of gallstone-related symptoms except one single-item question. Intraclass correlations ranged from 0.62 to 0.87. Cronbach's alpha ranged from 0.77 to 0.89. CONCLUSION: The Swedish translation of GIQLI has a high validity and reliability for assessing the impact of gallstones on quality of life.