Measurement of liver function using hepatobiliary scintigraphy improves risk assessment in patients undergoing major liver resection.

BACKGROUND: (99m)Tc-mebrofenin-hepatobiliary-scintigraphy (HBS) enables measurement of future remnant liver (FRL)-function and was implemented in our preoperative routine after calculation of the cut-off value for prediction of postoperative liver failure (LF). This study evaluates our results since the implementation of HBS. Additionally, CT-volumetric methods of FRL-assessment, standardized liver volumetry and FRL/body-weight ratio (FRL-BWR), were evaluated. METHODS: 163 patients who underwent major liver resection were included. Insufficient FRL-volume and/or FRL-function <2.7%/min/m(2) were indications for portal vein embolization (PVE). Non-PVE patients were compared with a historical cohort (n = 55). Primary endpoints were postoperative LF and LF related mortality. Secondary endpoint was preoperative identification of patients at risk for LF using the CT-volumetric methods. RESULTS: 29/163 patients underwent PVE; 8/29 patients because of insufficient FRL-function despite sufficient FRL-volume. According to FRL-BWR and standardized liver volumetry, 16/29 and 11/29 patients, respectively, would not have undergone PVE. LF and LF related mortality were significantly reduced compared to the historical cohort. HBS appeared superior in the identification of patients with increased surgical risk compared to the CT-volumetric methods. DISCUSSION: Implementation of HBS in the preoperative work-up led to a function oriented use of PVE and was associated with a significant decrease in postoperative LF and LF related mortality.

Preoperative computed tomography assessment of skeletal muscle mass is valuable in predicting outcomes following hepatectomy for perihilar cholangiocarcinoma.

BACKGROUND: Liver surgery for perihilar cholangiocarcinoma (PHC) is associated with high rates of morbidity and mortality. OBJECTIVES: This study investigated the impact of low skeletal muscle mass on short- and longterm outcomes following hepatectomy for PHC. METHODS: Patients included underwent liver surgery for PHC between 1998 and 2013. Total skeletal muscle mass was measured at the level of the third lumbar vertebra using available preoperative computed tomography images. Sex-specific cut-offs for low skeletal muscle mass were determined by optimal stratification. RESULTS: In 100 patients, low skeletal muscle mass was present in 42 (42.0%) subjects. The rate of postoperative complications (Clavien-Dindo Grade III and higher) was greater in patients with low skeletal muscle mass (66.7% versus 48.3%; multivariable adjusted P = 0.070). Incidences of sepsis (28.6% versus 5.2%) and liver failure (35.7% versus 15.5%) were increased in patients with low skeletal muscle mass. In addition, 90-day mortality was associated with low skeletal muscle mass in univariate analysis (28.6% versus 8.6%; P = 0.009). Median overall survival was shorter in patients with low muscle mass (22.8 months versus 47.5 months; P = 0.014). On multivariable analysis, low skeletal muscle mass remained a significant prognostic factor (hazard ratio 2.02; P = 0.020). CONCLUSIONS: Low skeletal muscle mass has a negative impact on postoperative mortality and overall survival following resection of PHC and should therefore be considered in preoperative risk assessment.

Quantifying the demand for hospital care services: a time and motion study.

BACKGROUND: The actual amount of care hospitalised patients need is unclear. A model to quantify the demand for hospital care services among various clinical specialties would avail healthcare professionals and managers to anticipate the demand and costs for clinical care. METHODS: Three medical specialties in a Dutch university hospital participated in this prospective time and motion study. To include a representative sample of patients admitted to clinical wards, the most common admission diagnoses were selected from the most recent update of the national medical registry (LMR) of ICD-10 admission diagnoses. The investigators recorded the time spent by physicians and nurses on patient care. Also the costs involved in medical and nursing care, (surgical) interventions, and diagnostic procedures as an estimate of the demand for hospital care services per hospitalised patient were calculated and cumulated. Linear regression analysis was applied to determine significant factors including patient and healthcare outcome characteristics. RESULTS: Fifty patients on the Surgery (19), Pediatrics (17), and Obstetrics & Gynecology (14) wards were monitored during their hospitalization. Characteristics significantly associated with the demand for healthcare were: polypharmacy during hospitalization, complication severity level, and whether a surgical intervention was performed. CONCLUSIONS: A set of predictors of the demand for hospital care services was found applicable to different clinical specialties. These factors can all be identified during hospitalization and be used as a managerial tool to monitor the patients' demand for hospital care services and to detect trends in time.

Trial-based cost-effectiveness analysis comparing surgical and endoscopic drainage in patients with obstructive chronic pancreatitis.

OBJECTIVE: Published evidence indicates that surgical drainage of the pancreatic duct was more effective than endoscopic drainage for patients with chronic pancreatitis. This analysis assessed the cost-effectiveness of surgical versus endoscopic drainage in obstructive chronic pancreatitis. DESIGN: This trial-based cost-utility analysis (ISRCTN04572410) was conducted from a UK National Health Service (NHS) perspective and during a 79-month time horizon. During the trial the details of the diagnostic and therapeutic procedures, and pancreatic insufficiency were collected. The resource use was varied in the sensitivity analysis based on a review of the literature. The health outcome was the Quality-Adjusted Life Year (QALY), generated using EQ-5D data collected during the trial. There were no pancreas-related deaths in the trial. All-cause mortality from the trial was incorporated into the QALY estimates in the sensitivity analysis. SETTING: Hospital. PARTICIPANTS: Patients with obstructive chronic pancreatitis. PRIMARY AND SECONDARY OUTCOME MEASURES: Costs, QALYs and cost-effectiveness. RESULTS: The result of the base-case analysis was that surgical drainage dominated endoscopic drainage, being both more effective and less costly. The sensitivity analysis varied mortality and resource use and showed that the surgical option remained dominant in all scenarios. The probability of cost-effectiveness for surgical drainage was 100% for the base case and 82% in the assessed most conservative case scenario. CONCLUSIONS: In obstructive chronic pancreatitis, surgical drainage is highly cost-effective compared with endoscopic drainage from a UK NHS perspective.

Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial.

BACKGROUND: In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis. METHODS/DESIGN: The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least 15 points on the Izbicki pain score during follow-up. To detect this difference a total of 88 patients will be randomized (alpha 0.05, power 90%, drop-out 10%). DISCUSSION: The ESCAPE trial will investigate whether early surgery in chronic pancreatitis is beneficial in terms of pain relief, pancreatic function and quality of life, compared with current step-up practice. TRIAL REGISTRATION: ISRCTN: ISRCTN45877994.

[Reliability of the registration of data on complex patients: effects on the hospital standardised mortality ratio (HSMR) in the Netherlands]. / Betrouwbaarheid dataregistratie van complexe patiënten: invloed op het gestandaardiseerde ziekenhuissterftecijfer (HSMR).

OBJECTIVE: To evaluate the reliability of data registration in calculating the hospital standardised mortality ratio (HSMR). DESIGN: Retrospective, descriptive. METHOD: Data were collected from a research database on all patients who had undergone a partial pancreatoduodenectomy for pancreatic cancer in 2009 and 2010 at our hospital. These data were compared with information about these same patients recorded in the Dutch National Medical Registry (LMR), obtained from the medical administration department of our hospital. The differences between these 2 databases were evaluated on the basis of 3 variables: mortality, main diagnosis and secondary diagnoses (differentiated into complications and co-morbidities). Using the Charlson index, the co-morbidity score from both registries was calculated per patient. RESULTS: A total of 118 patients had been registered in the research database. Of these patients, 103 appeared in the LMR data; 15 had not been registered in this database. There were no differences in patient characteristics or mortality (2.5%) between the registries. In the LMR, the main diagnosis of 5 patients had been incorrectly recorded. This database contained information on 136 complications and 51 co-morbidities, of which 35 comorbities had been correctly recorded. The research database contained information on 188 complications and 99 comorbidities on these same patients. In the research database, comorbidity comprised 34% of all secondary diagnoses; in the LMR, 19% (p < 0.001). The median score on the Charlson index was 0 for all patients in the LMR and 3 in the research database (p < 0.001). CONCLUSION: Comorbidities in patients with pancreatic carcinoma who undergo a resection are being inadequately recorded in the LMR. This results in insufficient correction in the case mix and a low score on the Charlson index, which could result in an incorrect HSMR.

[The centralisation of highly complex operations]. / Centralisatie van hoogcomplexe chirurgie.

The relationship between hospital volume and outcome of care after pancreatic surgery, particularly mortality, has been described extensively in the past. Today, this relationship is frequently being used by healthcare providers and/or insurance companies to select hospitals for various surgical procedures. This concept, however, has many limitations. The conceptual model concerning the relationship between how hospital facilities are arranged and the different aspects of the process of providing healthcare is discussed in three case histories describing complicated postoperative courses after pancreatic resections. The conclusion is that, besides hospital volume, the manner in which the various facilities in hospitals are arranged as well as the process of care giving, particularly the effectiveness of multidisciplinary meetings, are of crucial importance to the quality of care. Data per illness, with adequate correction for case mix, are of crucial importance for comparing the differences in quality of care between hospitals.

New diagnostic criteria and severity assessment of acute cholecystitis in revised Tokyo Guidelines.

BACKGROUND: The Tokyo Guidelines for the management of acute cholangitis and cholecystitis (TG07) were published in 2007 as the world's first guidelines for acute cholangitis and cholecystitis. The diagnostic criteria and severity assessment of acute cholecystitis have since been widely used all over the world. A validation study of TG07 has shown that the diagnostic criteria for acute cholecystitis are highly reliable but that the definition of definite diagnosis is ambiguous. In addition, considerable new evidence referring to acute cholecystitis as well as evaluations of TG07 have been published. Consequently, we organized the Tokyo Guidelines Revision Committee to evaluate TG07, recognize new evidence, and conduct a multi-center analysis to revise the guidelines (TG13). METHODS AND MATERIALS: We retrospectively analyzed 451 patients with acute cholecystitis from multiple tertiary care centers in Japan. All 451 patients were first evaluated using the criteria in TG07. The "gold standard" for acute cholecystitis in this study was a diagnosis by pathology. The validity of TG07 diagnostic criteria was investigated by comparing clinical with pathological diagnosis. RESULTS: Of 451 patients evaluated, a total of 227 patients were given a diagnosis of acute cholecystitis by pathological examination (prevalence 50.3 %). TG07 criteria provided a definite diagnosis of acute cholecystitis in 224 patients. The sensitivity of TG07 diagnostic criteria for acute cholecystitis was 92.1 %, and the specificity was 93.3 %. Based on the preliminary results, new diagnostic criteria for acute cholecystitis were proposed. Using the new criteria, the sensitivity of definite diagnosis was 91.2 %, and the specificity was 96.9 %. The accuracy rate was improved from 92.7 to 94.0 %. In regard to severity grading among 227 patients, 111 patients were classified as Mild (Grade I), 104 as Moderate (Grade II), and 12 as Severe (Grade III). CONCLUSION: The proposed new diagnostic criteria achieved better performance than the diagnostic criteria in TG07. Therefore, the proposed criteria have been adopted as new diagnostic criteria for acute cholecystitis and are referred to as the 2013 Tokyo Guidelines (TG13). Regarding severity assessment, no new evidence was found to suggest that the criteria in TG07 needed major adjustment. As a result, TG07 severity assessment criteria have been adopted in TG13 with minor changes.

New diagnostic criteria and severity assessment of acute cholangitis in revised Tokyo Guidelines.

BACKGROUND: The Tokyo Guidelines for the management of acute cholangitis and cholecystitis were published in 2007 (TG07) and have been widely cited in the world literature. Because of new information that has been published since 2007, we organized the Tokyo Guidelines Revision Committee to conduct a multicenter analysis to develop the updated Tokyo Guidelines (TG13). METHODS/MATERIALS: We retrospectively analyzed 1,432 biliary disease cases where acute cholangitis was suspected. The cases were collected from multiple tertiary care centers in Japan. The 'gold standard' for acute cholangitis in this study was that one of the three following conditions was present: (1) purulent bile was observed; (2) clinical remission following bile duct drainage; or (3) remission was achieved by antibacterial therapy alone, in patients in whom the only site of infection was the biliary tree. Comparisons were made for the validity of each diagnostic criterion among TG13, TG07 and Charcot's triad. RESULTS: The major changes in diagnostic criteria of TG07 were re-arrangement of the diagnostic items and exclusion of abdominal pain from the diagnostic list. The sensitivity improved from 82.8 % (TG07) to 91.8 % (TG13). While the specificity was similar to TG07, the false positive rate in cases of acute cholecystitis was reduced from 15.5 to 5.9 %. The sensitivity of Charcot's triad was only 26.4 % but the specificity was 95.6 %. However, the false positive rate in cases of acute cholecystitis was 11.9 % and not negligible. As for severity grading, Grade II (moderate) acute cholangitis is defined as being associated with any two of the significant prognostic factors which were derived from evidence presented recently in the literature. The factors chosen allow severity assessment to be performed soon after diagnosis of acute cholangitis. CONCLUSION: TG13 present a new standard for the diagnosis, severity grading, and management of acute cholangitis.

Nature and timing of incidents intercepted by the SURPASS checklist in surgical patients.

INTRODUCTION: More than half of in-hospital adverse events can be attributed to a surgical discipline. Checklists can effectively decrease errors and adverse events. However, the mechanisms by which checklists lead to increased safety are unclear. This study aimed to assess the number, nature and timing of incidents intercepted by use of the Surgical Patient Safety System (SURPASS) checklist, a patient-specific multidisciplinary checklist that covers the entire surgical patient pathway. METHODS: The checklist was implemented in two academic hospitals and four teaching hospitals in the Netherlands. Users of the checklist had three options for each item that was checked: 'not applicable', 'yes' and 'intercepted by checklist'. In each hospital, the first 1000 completed checklists were entered into an online central database. RESULTS: In six participating hospitals, 6313 checklists were collected. One or more incidents were intercepted in 2562 checklists (40.6%). In total, 6312 incidents were intercepted. After correction for the number of items and the extent of adherence in each part of the checklist, the number of intercepted incidents was highest in the preoperative and postoperative stages. CONCLUSIONS: The checklist intercepts many potentially harmful incidents across all stages of the surgical patient pathway. The majority of incidents were intercepted in the preoperative and postoperative stages of the pathway. The degree to which these incidents would have been intercepted by a single checklist in the operating room only, compared with a checklist for the entire surgical pathway, remains a subject for future study.

Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. METHODS/DESIGN: The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. DISCUSSION: The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2666.

Long-term outcomes of endoscopic vs surgical drainage of the pancreatic duct in patients with chronic pancreatitis.

BACKGROUND & AIMS: A randomized trial that compared endoscopic and surgical drainage of the pancreatic duct in patients with advanced chronic pancreatitis reported a significant benefit of surgery after a 2-year follow-up period. We evaluated the long-term outcome of these patients after 5 years. METHODS: Between 2000 and 2004, 39 symptomatic patients were randomly assigned to groups that underwent endoscopic drainage or operative pancreaticojejunostomy. In 2009, information was collected regarding pain, quality of life, morbidity, mortality, length of hospital stay, number of procedures undergone, changes in pancreatic function, and costs. Analysis was performed according to an intention-to-treat principle. RESULTS: During the 79-month follow-up period, one patient was lost and 7 died from unrelated causes. Of the patients treated by endoscopy, 68% required additional drainage compared with 5% in the surgery group (P = .001). Hospital stay and costs were comparable, but overall, patients assigned to endoscopy underwent more procedures (median, 12 vs 4; P = .001). Moreover, 47% of the patients in the endoscopy group eventually underwent surgery. Although the mean difference in Izbicki pain scores was no longer significant (39 vs 22; P = .12), surgery was still superior in terms of pain relief (80% vs 38%; P = .042). Levels of quality of life and pancreatic function were comparable. CONCLUSIONS: In the long term, symptomatic patients with advanced chronic pancreatitis who underwent surgery as the initial treatment for pancreatic duct obstruction had more relief from pain, with fewer procedures, than patients who were treated endoscopically. Importantly, almost half of the patients who were treated with endoscopy eventually underwent surgery.

Prevention of surgical malpractice claims by use of a surgical safety checklist.

OBJECTIVE: To assess what proportion of surgical malpractice claims might be prevented by the use of a surgical safety checklist. BACKGROUND: Surgical disciplines are overrepresented in the distribution of adverse events. The recently described multidisciplinary SURgical PAtient Safety System (SURPASS) checklist covers the entire surgical pathway from admission to discharge and is being validated in various ways. Malpractice claims constitute an important source of information on adverse events. In this study, surgical malpractice claims were evaluated in detail to assess the proportion and nature of claims that might have been prevented if the SURPASS checklist had been used. METHODS: A retrospective claim record review was performed using the database of the largest Dutch insurance company for medical liability. All accepted or settled closed surgical malpractice claims filed as a consequence of an incident that occurred between January 1, 2004 and December 31, 2005 were included. Data on the type and outcome of the incident and contributing factors were extracted. All contributing factors were compared to the SURPASS checklist to assess which incidents the checklist might have prevented. RESULTS: We included 294 claims. Failure in diagnosis and peroperative damage were the most common types of incident; cognitive contributing factors were present in two-thirds of claims. Of a total of 412 contributing factors, 29% might have been intercepted by the SURPASS checklist. The checklist might have prevented 40% of deaths and 29% of incidents leading to permanent damage. CONCLUSION: Nearly one-third of all contributing factors in accepted surgical malpractice claims of patients that had undergone surgery might have been intercepted by using a comprehensive surgical safety checklist. A considerable amount of damage, both physical and financial, is likely to be prevented by using the SURPASS checklist.

Costs of relaparotomy on-demand versus planned relaparotomy in patients with severe peritonitis: an economic evaluation within a randomized controlled trial.

INTRODUCTION: Results of the first randomized trial comparing on-demand versus planned-relaparotomy strategy in patients with severe peritonitis (RELAP trial) indicated no clear differences in primary outcomes. We now report the full economic evaluation for this trial, including detailed methods, nonmedical costs, further differentiated cost calculations, and robustness of different assumptions in sensitivity analyses. METHODS: An economic evaluation was conducted from a societal perspective alongside a randomized controlled trial in 229 patients with severe secondary peritonitis and an acute physiology and chronic health evaluation (APACHE)-II score >or=11 from two academic and five regional teaching hospitals in the Netherlands. After the index laparotomy, patients were randomly allocated to an on-demand or a planned-relaparotomy strategy. Primary resource-utilization data were used to estimate mean total costs per patient during the index admission and after discharge until 1 year after the index operation. Overall differences in costs between the on-demand relaparotomy strategy and the planned strategy, as well as relative differences across several clinical subgroups, were evaluated. RESULTS: Costs were substantially lower in the on-demand group (mean, 65,768 euro versus 83,450 euro per patient in the planned group; mean absolute difference, 17,682 euro; 95% CI, 5,062 euro to e29,004 euro). Relative differences in mean total costs per patient (approximately 21%) were robust to various alternative assumptions. Planned relaparotomy consistently generated more costs across the whole range of different courses of disease (quick recovery and few resources used on one end of the spectrum; slow recovery and many resources used on the other end). This difference in costs between the two surgical strategies also did not vary significantly across several clinical subgroups. CONCLUSIONS: The reduction in societal costs renders the on-demand strategy a more-efficient relaparotomy strategy in patients with severe peritonitis. These differences were found across the full range of healthcare resources as well as across patients with different courses of disease. TRIAL REGISTRATION: ISRCTN51729393.

Assessment of future remnant liver function using hepatobiliary scintigraphy in patients undergoing major liver resection.

BACKGROUND: (99m)Tc-mebrofenin hepatobiliary scintigraphy (HBS) was used as a quantitative method to evaluate liver function. The aim of this study was to compare future remnant liver function assessed by (99m)Tc-mebrofenin hepatobiliary scintigraphy with future remnant liver volume in the prediction of liver failure after major liver resection. METHODS: Computed tomography (CT) volumetry and (99m)Tc-mebrofenin hepatobiliary scintigraphy were performed prior to major resection in 55 high-risk patients, including 30 patients with parenchymal liver disease. Liver volume was expressed as percentage of total liver volume or as standardized future remnant liver volume. Receiver operating characteristic (ROC) curve analysis was performed to identify a cutoff value for future remnant liver function in predicting postoperative liver failure. RESULTS: Postoperative liver failure occurred in nine patients. A liver function cutoff value of 2.69%/min/m(2) was calculated by ROC curve analysis. (99m)Tc-mebrofenin hepatobiliary scintigraphy demonstrated better sensitivity, specificity, and positive and negative predictive value compared to future remnant liver volume. Using 99mTc-mebrofenin hepatobiliary scintigraphy, one cutoff value suffices in both compromised and noncompromised patients. CONCLUSION: Preoperative (99m)Tc-mebrofenin hepatobiliary scintigraphy is a valuable technique to estimate the risk of postoperative liver failure. Especially in patients with uncertain quality of the liver parenchyma, (99m)Tc-mebrofenin HBS proved of more value than CT volumetry.

Litigation after laparoscopic cholecystectomy: an evaluation of the Dutch arbitration system for medical malpractice.

BACKGROUND: Medical liability is a great concern in current surgical practice. The medical liability system in the US is under discussion in surgical literature, as the system is associated with high costs and expensive liability premiums. The aim of this study was to evaluate the Dutch arbitration system for claims filed after bile duct injury (BDI). STUDY DESIGN: Data were extracted from the largest Dutch insurance company for medical liability. Outcomes of the claim and factors associated with awarded financial compensation were determined. RESULTS: BDI litigation after laparoscopic cholecystectomy occurred in 0.08% (+/- 0.02% SD) without a substantial increase. Currently, 88 of 133 claims are closed after a median duration of 2 years (range 5 months to 6.5 years). In 61 of 88 cases (69%) liability was rejected, and in 16 cases (18%) liability was acknowledged. Median compensation (in Euros) was euro 9.826,07 (range euro 15,88 to euro 55.301,06). Rejection of liability increased from 50% in the period 1994 to 1998 versus 72% in 2004 to 2006 (p = 0.023). Factors associated with recognition were patient employment (p = 0.005) and patient death (p = 0.01). Factors associated with an increase in financial compensation are delay in imaging (p = 0.033), delay in diagnosis (p = 0.009), and relaparotomy with repair in the initial hospital (p = 0.028). CONCLUSIONS: The Dutch arbitration system for medical liability after BDI is associated with a short time to resolution and high rejection rates, and payments to BDI patients are low.

Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial.

CONTEXT: In patients with severe secondary peritonitis, there are 2 surgical treatment strategies following an initial emergency laparotomy: planned relaparotomy and relaparotomy only when the patient's condition demands it ("on-demand"). The on-demand strategy may reduce mortality, morbidity, health care utilization, and costs. However, randomized trials have not been performed. OBJECTIVE: To compare patient outcome, health care utilization, and costs of on-demand and planned relaparotomy. DESIGN, SETTING, AND PATIENTS: Randomized, nonblinded clinical trial at 2 academic and 5 regional teaching hospitals in the Netherlands from November 2001 through February 2005. Patients had severe secondary peritonitis and an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 11 or greater. INTERVENTION: Random allocation to on-demand or planned relaparotomy strategy. MAIN OUTCOME MEASURES: The primary end point was death and/or peritonitis-related morbidity within a 12-month follow-up period. Secondary end points included health care utilization and costs. RESULTS: A total of 232 patients (116 on-demand and 116 planned) were randomized. One patient in the on-demand group was excluded due to an operative diagnosis of pancreatitis and 3 in each group withdrew or were lost to follow-up. There was no significant difference in primary end point (57% on-demand [n = 64] vs 65% planned [n = 73]; P = .25) or in mortality alone (29% on-demand [n = 32] vs 36% planned [n = 41]; P = .22) or morbidity alone (40% on-demand [n = 32] vs 44% planned [n = 32]; P = .58). A total of 42% of the on-demand patients had a relaparotomy vs 94% of the planned relaparotomy group. A total of 31% of first relaparotomies were negative in the on-demand group vs 66% in the planned group (P <.001). Patients in the on-demand group had shorter median intensive care unit stays (7 vs 11 days; P = .001) and shorter median hospital stays (27 vs 35 days; P = .008). Direct medical costs per patient were reduced by 23% using the on-demand strategy. CONCLUSION: Patients in the on-demand relaparotomy group did not have a significantly lower rate of death or major peritonitis-related morbidity compared with the planned relaparotomy group but did have a substantial reduction in relaparotomies, health care utilization, and medical costs. TRIAL REGISTRATION: http://isrctn.org Identifier: ISRCTN51729393.

Risk assessment of posthepatectomy liver failure using hepatobiliary scintigraphy and CT volumetry.

UNLABELLED: A major part of morbidity and mortality after liver resections is caused by inadequate remnant liver function leading to liver failure. It is therefore important to develop accurate diagnostic tools that can predict the risk of liver resection-related morbidity and mortality. In this study, preoperative hepatobiliary scintigraphy of the future remnant liver and CT volumetric measurement of the future remnant liver were performed on patients who were to undergo liver resection. The accuracy of risk assessment for postoperative morbidity, liver failure, and mortality was evaluated. METHODS: Forty-six patients who were scheduled for liver resection because of hepatobiliary tumors, including 17 patients with parenchymal disease (37%) and 13 patients with hilar cholangiocarcinoma (28%), were assessed preoperatively. Hepatobiliary scintigraphy was performed by drawing regions of interest around the future remnant to calculate (99m)Tc-mebrofenin uptake in it. CT volumetry was used to measure the volume of the total liver, the tumors, and the future remnant. Receiver-operating-characteristic analysis was performed to assess cutoff values for risk assessment of morbidity, liver failure, and mortality. Furthermore, univariate and multivariate analyses were performed to determine factors related to morbidity and mortality. RESULTS: Morbidity and mortality rates were 61% and 11%, respectively. Liver failure occurred in 6 patients (13%). Significantly decreased uptake in the future remnant was found in patients in whom liver failure and liver failure-related mortality developed (P=0.003 and 0.02, respectively). The volume of the future remnant was not significantly associated with any of the outcome parameters. In receiver-operating-characteristic analysis, uptake cutoff values for liver failure and liver failure-related mortality were 2.5%/min/body surface area and 2.2%/min/body surface area, respectively. In multivariate analysis, uptake was the only significant factor associated with liver failure. CONCLUSION: Preoperative measurement of (99m)Tc-mebrofenin uptake in the future remnant liver on hepatobiliary scintigraphy proved more valuable than measurement of the volume of the future remnant on CT in assessing the risk of liver failure and liver failure-related mortality after partial liver resection.

Medical liability insurance claims on entry-related complications in laparoscopy.

BACKGROUND: Installation of the pneumoperitoneum is an essential part of laparoscopic surgery. Creation can be performed by either the open or a closed technique. The aim of this study was to assess the number of and contributing factors to entry-related complications in medical liability insurance claims in The Netherlands. METHODS: A retrospective chart review was performed, including all malpractice claims filed at MediRisk, which is presently the largest medical liability mutual insurance company for institutions, mainly hospitals, in healthcare in The Netherlands. RESULTS: From January 1993 to December 2005, 41 claims were identified as entry-related complications which comprised 18% of all laparoscopy-related complications leading to claims. Most were young (median age = 35 years) female patients who had routine, nonadvanced, laparoscopic procedures planned as short-stay or day-care procedures. The claims were equally divided between general surgery (n = 20) and gynecology (n = 21). A total of 51 structures were injured. There were 18 vascular structure injuries, 30 bowel injuries, and three other injuries. An open entry technique was used in only two (5%) patients. Vascular injury was exclusively associated with closed entry. In only 19 (46%) patients the entry-related complication was diagnosed peroperatively, consisting of 70% of the vascular and 25% of the bowel injuries. Twenty-six patients (64%) were admitted to the intensive care unit for a median of five days. There was no mortality. Besides conversion, the majority of the patients filed a claim to compensate for a longer hospital stay and related costs. A payment was made in 17 (57%) of the 30 settled claims. CONCLUSIONS: Medical liability claims concerning laparoscopic entry-related complications comprised a fifth of all laparoscopy-related claims. Claims concerning entry-related complications occurred in young patients who had routine, nonadvanced procedures. In the investigated cases most claims involved the closed-entry technique.