The prevalence of non-accidental trauma among children with polytrauma: A nationwide level-I trauma centre study.

OBJECTIVE: We aimed to investigate the prevalence and characteristics of non-accidental trauma (NAT) in children with polytrauma treated at level-I trauma centres (TC). SUMMARY OF BACKGROUND: Data 6-10% Of children who present at the emergency department with injuries, sustain polytrauma. Polytrauma may result from either accidental (AT) or NAT, i.e. inflicted or neglect. The prevalence of NAT among children with polytrauma is currently unclear. METHODS: This is a retrospective study that included children (0-18 years) with an Injury Severity Score >15, who presented at one of the 11 Level-I trauma centers (TC) in the Netherlands between January 1, 2010 and January 1, 2016. Outcomes were classified based on the conclusions of the Child Abuse and Neglect-team. Cases in which conclusions were unavailable and there was no clear accidental cause of injuries were reviewed by an expert panel. RESULTS: The study included 1623 children, 1452 (89%) were classified as AT, 171 (11%) as NAT; 39 (2,4%) inflicted and 132 (8,1%) neglect. Of pre-school aged children (<5 years) 41% sustained NAT (OR26.73, 95%CI 17.70-40.35), 35/342 (10%) inflicted and 104/342 (31%) neglect. Admission due to 'cardiopulmonary arrest' was the result of inflicted trauma (30% vs 0%,p < 0.001). NAT had a higher mortality rate (16% vs 10%, p = 0.006). Indicators of NAT were: (near-)drowning (OR10.74, 95%CI 5.94-19.41), burn (OR8.62, 95%CI 4.08-18.19) and fall from height (OR2.18, 95%CI 1.56-3.02). CONCLUSIONS: NAT was the cause of polytrauma in 11% of children in our nationwide level-I TC study; 41% of these polytrauma were the result of NAT experienced by preschool-aged children. Our data show the importance of awareness for NAT.

Prevalence of inflicted and neglectful femur shaft fractures in young children in national level I trauma centers.

BACKGROUND: The prevalence of inflicted femur fractures in young children varies (1.5-35.2%), but these data are based on small retrospective studies with high heterogeneity. Age and mobility of the child seem to be indicators of inflicted trauma. OBJECTIVE: This study describes other factors associated with inflicted and neglectful trauma that can be used to distinguish inflicted and neglectful from accidental femur fractures. MATERIALS AND METHODS: This retrospective study included children (0-6 years) who presented with an isolated femur fracture at 1 of the 11 level I trauma centers in the Netherlands between January 2010 and January 2016. Outcomes were classified based on the conclusions of the Child Abuse and Neglect teams or the court. Cases in which conclusions were unavailable and there was no clear accidental cause were reviewed by an expert panel. RESULTS: The study included 328 children; 295 (89.9%) cases were classified as accidental trauma. Inflicted trauma was found in 14 (4.3%), while 19 (5.8%) were cases of neglect. Indicators of inflicted trauma were age 0-5 months (29%, positive likelihood ratio [LR +] 8.35), 6-12 months (18%, LR + 5.98) and 18-23 months (14%, LR + 3.74). Indicators of neglect were age 6-11 months (18%, LR + 4.41) and age 18-23 months (8%, LR + 1.65). There was no difference in fracture morphology among groups. CONCLUSION: It is unlikely that an isolated femur fracture in ambulatory children age > 24 months is caused by inflicted trauma/neglect. Caution is advised in children younger than 24 months because that age is the main factor associated with inflicted trauma/neglect and inflicted femur fractures.

Severe isolated injuries have a high impact on resource use and mortality: a Dutch nationwide observational study.

PURPOSE: The Berlin poly-trauma definition (BPD) has proven to be a valuable way of identifying patients with at least a 20% risk of mortality, by combining anatomical injury characteristics with the presence of physiological risk factors (PRFs). Severe isolated injuries (SII) are excluded from the BPD. This study describes the characteristics, resource use and outcomes of patients with SII according to their injured body region, and compares them with those included in the BPD. METHODS: Data were extracted from the Dutch National Trauma Registry between 2015 and 2019. SII patients were defined as those with an injury with an Abbreviated Injury Scale (AIS) score ≥ 4 in one body region, with at most minor additional injuries (AIS ≤ 2). We performed an SII subgroup analysis per AIS region of injury. Multivariable linear and logistic regression models were used to calculate odds ratios (ORs) for SII subgroup patient outcomes, and resource needs. RESULTS: A total of 10.344 SII patients were included; 47.8% were ICU admitted, and the overall mortality was 19.5%. The adjusted risk of death was highest for external (2.5, CI 1.9-3.2) and for head SII (2.0, CI 1.7-2.2). Patients with SII to the abdomen (2.3, CI 1.9-2.8) and thorax (1.8, CI 1.6-2.0) had a significantly higher risk of ICU admission. The highest adjusted risk of disability was recorded for spine injuries (10.3, CI 8.3-12.8). The presence of ≥ 1 PRFs was associated with higher mortality rates compared to their poly-trauma counterparts, displaying rates of at least 15% for thoracic, 17% for spine, 22% for head and 49% for external SII. CONCLUSION: A severe isolated injury is a high-risk entity and should be recognized and treated as such. The addition of PRFs to the isolated anatomical injury criteria contributes to the identification of patients with SII at risk of worse outcomes.

The Detrimental Impact of the COVID-19 Pandemic on Major Trauma Outcomes in the Netherlands: A Comprehensive Nationwide Study.

OBJECTIVE: To evaluate the impact of the COVID-19 pandemic on the outcome of major trauma patients in the Netherlands. SUMMARY BACKGROUND DATA: Major trauma patients highly rely on immediate access to specialized services, including ICUs, shortages caused by the impact of the COVID-19 pandemic may influence their outcome. METHODS: A multi-center observational cohort study, based on the Dutch National Trauma Registry was performed. Characteristics, resource usage, and outcome of major trauma patients (injury severity score ≥16) treated at all trauma-receiving hospitals during the first COVID-19 peak (March 23 through May 10) were compared with those treated from the same period in 2018 and 2019 (reference period). RESULTS: During the peak period, 520 major trauma patients were admitted, versus 570 on average in the pre-COVID-19 years. Significantly fewer patients were admitted to ICU facilities during the peak than during the reference period (49.6% vs 55.8%; P=0.016). Patients with less severe traumatic brain injuries in particular were less often admitted to the ICU during the peak (40.5% vs 52.5%; P=0.005). Moreover, this subgroup showed an increased mortality compared to the reference period (13.5% vs 7.7%; P=0.044). These results were confirmed using multivariable logistic regression analyses. In addition, a significant increase in observed versus predicted mortality was recorded for patients who had a priori predicted mortality of 50% to 75% (P=0.012). CONCLUSIONS: The COVID-19 peak had an adverse effect on trauma care as major trauma patients were less often admitted to ICU and specifically those with minor through moderate brain injury had higher mortality rates.

The impact of regionalized trauma care on the distribution of severely injured patients in the Netherlands.

BACKGROUND: Twenty years ago, an inclusive trauma system was implemented in the Netherlands. The goal of this study was to evaluate the impact of structured trauma care on the concentration of severely injured patients over time. METHODS: All severely injured patients (Injury Severity Score [ISS] ≥ 16) documented in the Dutch Trauma Registry (DTR) in the calendar period 2008-2018 were included for analysis. We compared severely injured patients, with and without severe neurotrauma, directly brought to trauma centers (TC) and non-trauma centers (NTC). The proportion of patients being directly transported to a trauma center was determined, as was the total Abbreviated Injury Score (AIS), and ISS. RESULTS: The documented number of severely injured patients increased from 2350 in 2008 to 4694 in 2018. During this period, on average, 70% of these patients were directly admitted to a TC (range 63-74%). Patients without severe neurotrauma had a lower chance of being brought to a TC compared to those with severe neurotrauma. Patients directly presented to a TC were more severely injured, reflected by a higher total AIS and ISS, than those directly transported to a NTC. CONCLUSION: Since the introduction of a well-organized trauma system in the Netherlands, trauma care has become progressively centralized, with more severely injured patients being directly presented to a TC. However, still 30% of these patients is initially brought to a NTC. Future research should focus on improving pre-hospital triage to facilitate swift transfer of the right patient to the right hospital.

High prevalence of non-accidental trauma among deceased children presenting at Level I trauma centers in the Netherlands.

PURPOSE: Between 0.1-3% of injured children who present at a hospital emergency department ultimately die as a result of their injuries. These events are typically reported as unnatural causes of death and may result from either accidental or non-accidental trauma (NAT). Examples of the latter include trauma that is inflicted directly or resulting from neglect. Although consultation with a forensic physician is mandatory for all deceased children, the prevalence of fatal inflicted trauma or neglect among children is currently unclear. METHODS: This is a retrospective study that included children (0-18 years) who presented and died at one of the 11 Level I trauma centers in the Netherlands between January 1, 2014, and January 1, 2019. Outcomes were classified based on the conclusions of the Child Abuse and Neglect team or those of forensic pathologists and/or the court in cases referred for legally mandated autopsies. Cases in which conclusions were unavailable and there was no clear accidental cause of death were reviewed by an expert panel. RESULTS: The study included 175 cases of childhood death. Seventeen (9.7%) of these children died due to inflicted trauma (9.7%), 18 (10.3%) due to neglect, and 140 (80%) due to accidents. Preschool children (< 5 years old) were significantly more likely to present with injuries due to inflicted trauma and neglect compared to older children (44% versus 6%, p < 0.001, odds ratio [OR] 5.80, 95% confidence interval [CI] 2.66-12.65). Drowning accounted for 14 of the 18 (78%) pediatric deaths due to neglect, representing 8% of the total cases. Postmortem radiological studies and autopsies were performed on 37 (21%) of all cases of childhood death. CONCLUSION: One of every five pediatric deaths in our nationwide Level I trauma center study was attributed to NAT; 44% of these deaths were the result of trauma experienced by preschool-aged children. A remarkable number of fatal drownings were due to neglect. Postmortem radiological studies and autopsies were performed in only one-fifth of all deceased children. The limited use of postmortem investigations may have resulted in missed cases of NAT, which will result in an overall underestimation of fatal NAT experienced by children.

Dutch trauma system performance: Are injured patients treated at the right place?

BACKGROUND: The goal of trauma systems is to match patient care needs to the capabilities of the receiving centre. Severely injured patients have shown better outcomes if treated in a major trauma centre (MTC). We aimed to evaluate patient distribution in the Dutch trauma system. Furthermore, we sought to identify factors associated with the undertriage and transport of severely injured patients (Injury Severity Score (ISS) >15) to the MTC by emergency medical services (EMS). METHODS: Data on all acute trauma admissions in the Netherlands (2015-2016) were extracted from the Dutch national trauma registry. An ambulance driving time model was applied to calculate MTC transport times and transport times of ISS >15 patients to the closest MTC and non-MTC. A multivariable logistic regression analysis was performed to identify factors associated with ISS >15 patients' EMS undertriage to an MTC. RESULTS: Of the annual average of 78,123 acute trauma admissions, 4.9% had an ISS >15. The nonseverely injured patients were predominantly treated at non-MTCs (79.2%), and 65.4% of patients with an ISS >15 received primary MTC care. This rate varied across the eleven Dutch trauma networks (36.8%-88.4%) and was correlated with the transport times to an MTC (Pearson correlation -0.753, p=0.007). The trauma networks also differed in the rates of secondary transfers of ISS >15 patients to MTC hospitals (7.8% - 59.3%) and definitive MTC care (43.6% - 93.2%). Factors associated with EMS undertriage of ISS >15 patients to the MTC were female sex, older age, severe thoracic and abdominal injury, and longer additional EMS transport times. CONCLUSIONS: Approximately one-third of all severely injured patients in the Netherlands are not initially treated at an MTC. Special attention needs to be directed to identifying patient groups with a high risk of undertriage. Furthermore, resources to overcome longer transport times to an MTC, including the availability of ambulance and helicopter services, may improve direct MTC care and result in a decrease in the variation of the undertriage of severely injured patients to MTCs among the Dutch trauma networks. Furthermore, attention needs to be directed to improving primary triage guidelines and instituting uniform interfacility transfer agreements.

Evaluation of the Berlin polytrauma definition: A Dutch nationwide observational study.

BACKGROUND: The Berlin polytrauma definition (BPD) was established to identify multiple injury patients with a high risk of mortality. The definition includes injuries with an Abbreviated Injury Scale score of ≥3 in ≥2 body regions (2AIS ≥3) combined with the presence of ≥1 physiological risk factors (PRFs). The PRFs are based on age, Glasgow Coma Scale, hypotension, acidosis, and coagulopathy at specific cutoff values. This study evaluates and compares the BPD with two other multiple injury definitions used to identify patients with high resource utilization and mortality risk, using data from the Dutch National Trauma Register (DNTR). METHODS: The evaluation was performed based on 2015 to 2018 DNTR data. First, patient characteristics for 2AIS ≥3, Injury Severity Score (ISS) of ≥16, and BPD patients were compared. Second, the PRFs prevalence and odds ratios of mortality for 2AIS ≥3 patients were compared with those from the Deutsche Gesellschaft für Unfallchirurgie Trauma Register. Subsequently, the association between PRF and mortality was assessed for 2AIS ≥3-DNTR patients and compared with those with an ISS of ≥16. RESULTS: The DNTR recorded 300,649 acute trauma admissions. A total of 15,711 patients sustained an ISS of ≥16, and 6,263 patients had suffered a 2AIS ≥3 injury. All individual PRFs were associated with a mortality of >30% in 2AIS ≥3-DNTR patients. The increase in PRFs was associated with a significant increase in mortality for both 2AIS ≥3 and ISS ≥16 patients. A total of 4,264 patients met the BPDs criteria. Overall mortality (27.2%), intensive care unit admission (71.2%), and length of stay were the highest for the BPD group. CONCLUSION: This study confirms that the BPD identifies high-risk patients in a population-based registry. The addition of PRFs to the anatomical injury scores improves the identification of severely injured patients with a high risk of mortality. Compared with the ISS ≥16 and 2AIS ≥3 multiple injury definitions, the BPD showed to improve the accuracy of capturing patients with a high medical resource need and mortality rate. LEVEL OF EVIDENCE: Epidemiological study, level III.

A hybrid treatment modality of a subtrochanteric femoral fracture in a patient with osteoporosis due to a renal Fanconi syndrome: a case report.

A 24-year-old male with an idiopathic renal Fanconi syndrome presented to our ER after a low-energetic fall. Conventional imaging revealed a right subtrochanteric femoral fracture, severely decreased bone quality and cannulated collum femoris screws on the contralateral side. Regular plate-screw osteosynthesis or cephalomedullary implantation was deemed insufficient, due to a high iatrogenic and periprosthetic fracture probability. The decision was made to perform a plate-screw osteosynthesis combined with an intramedullary polymer bone enhancement (IlluminOss), to minimize this risk. No complications occurred perioperatively. The patient was able to walk independently two months postoperatively. This case shows that use of polymer implant as an enhancement of osteosynthesis in repair of fractures in the Fanconi syndrome is a safe and possible useful treatment method.

Superiority of Step-up Approach vs Open Necrosectomy in Long-term Follow-up of Patients With Necrotizing Pancreatitis.

BACKGROUND & AIMS: In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study. METHODS: We reevaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (±11 months) of follow-up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the Short Form-36 and EuroQol 5 dimensions forms), and Izbicki pain scores. RESULTS: From index admission to long-term follow-up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group (P = .005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P = .004), pancreatic exocrine insufficiency (29% vs 56%; P = .03), or endocrine insufficiency (40% vs 64%; P = .05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P = .99) or pancreatic surgery (11% vs 5%; P = .43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain scores, or medical costs. Quality of life increased during follow-up without a significant difference between groups. CONCLUSIONS: In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.

Volume-limited versus pressure-limited hemodynamic management in septic and nonseptic shock.

OBJECTIVES: To evaluate the effect of hemodynamic management guided by upper limits of cardiac filling volumes or pressures on durations of mechanical ventilation and lengths of stay in critically ill patients with shock. DESIGN: Prospective, randomized, clinical trial. SETTING: Mixed intensive care unit of a large teaching hospital and mixed intensive care unit of a tertiary care, academic medical center. PATIENTS: A total 120 septic (n = 72) and nonseptic (n = 48) shock patients, randomized (after stratification) to transpulmonary thermodilution (n = 60) or pulmonary artery catheter (n = 60) between February 2007 and July 2009. INTERVENTIONS: Hemodynamic management was guided by algorithms including upper limits for fluid resuscitation of extravascular lung water (<10 mL/kg) and global end-diastolic volume index (<850 mL/m) in the transpulmonary thermodilution group and pulmonary artery occlusion pressure (<18-20 mm Hg) in the pulmonary artery catheter group for 72 hrs after enrollment. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were ventilator-free days and lengths of stay in the intensive care unit and the hospital. Secondary outcomes included organ failures and mortality. Cardiac comorbidity was more frequent in nonseptic than in septic shock. Ventilator-free days, lengths of stay, organ failures, and 28-day mortality (overall 33.3%) were similar between monitoring groups. Transpulmonary thermodilution (vs. pulmonary artery catheter) monitoring was associated with more days on mechanical ventilation and longer intensive care unit and hospital lengths of stay in nonseptic (p = .001) but not in septic shock. In both conditions, fewer patients met the upper limit of volume than of pressure criteria at baseline and transpulmonary thermodilution (vs. pulmonary artery catheter) monitoring was associated with a more positive fluid balance at 24 hrs. CONCLUSIONS: Hemodynamic management guided by transpulmonary thermodilution vs. pulmonary artery catheter in shock did not affect ventilator-free days, lengths of stay, organ failures, and mortality of critically ill patients. Use of the a transpulmonary thermodilution algorithm resulted in more days on mechanical ventilation and intensive care unit length of stay compared with the pulmonary artery catheter algorithm in nonseptic shock but not in septic shock. This may relate to cardiac comorbidity and a more positive fluid balance with use of transpulmonary thermodilution in nonseptic shock.

Delayed primary closure of the septic open abdomen with a dynamic closure system.

BACKGROUND: The major challenge in the management of patients with an infected open abdomen (OA) is to control septic peritonitis and intra-abdominal fluid secretion, and to facilitate repeated abdominal exploration, while preserving the fascia for delayed primary closure. We here present a novel method for closure of the infected OA, based on continuous dynamic tension, in order to achieve re-approximation of the fascial edges of the abdominal wall. METHODS: Eighteen cases with severe peritonitis of various origin (e.g., gastrointestinal perforations, anastomotic leakage) were primarily stabilized by laparostomy, sealed with either the vacuum-assisted closure abdominal dressing or the Bogotá bag. After hemodynamic stabilization and control of the sepsis, the Abdominal Re-approximation Anchor System (ABRA; Canica Design, Almonte, Ontario, Canada) was applied. This system approximates the wound margins through dynamic traction exerted by transfascial elastomers. Before ABRA application, 5/18 patients had a grade 2B, 2/18 a grade 3, and 11/18 a grade or 4 status according to the open abdomen classification of Björck. RESULTS: In this severely ill population the mean time before ABRA system application was 12 days (range: 2-39 days). Two of 18 patients died of non-ABRA-related causes within three weeks. In 14 of the remaining 16 patients (88%) primary abdominal closure of the midline was accomplished in 15 days (range: 7-30 days). The other two patients needed a component separation technique according to Ramirez to reach closure. However, secondary wound dehiscence occurred in both these patients. Two thirds of patients (12/18) developed pressure sores to the skin and/or dermis, but all healed without further complications. During outpatient clinic follow-up, 4/14 successfully closed patients still developed a midline hernia. CONCLUSIONS: Delayed primary closure of OA in septic patients could be achieved in 88% with this new approximation system. However, the risk of hernia development remained. We consider this system a useful tool in the treatment of septic patients with an open abdomen.

A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome.

BACKGROUND & AIMS: Treatment of patients with necrotizing pancreatitis has become more conservative and less invasive, but there are few data from prospective studies to support the efficacy of this change. We performed a prospective multicenter study of treatment outcomes among patients with necrotizing pancreatitis. METHODS: We collected data from 639 consecutive patients with necrotizing pancreatitis, from 2004 to 2008, treated at 21 Dutch hospitals. Data were analyzed for disease severity, interventions (radiologic, endoscopic, surgical), and outcome. RESULTS: Overall mortality was 15% (n=93). Organ failure occurred in 240 patients (38%), with 35% mortality. Treatment was conservative in 397 patients (62%), with 7% mortality. An intervention was performed in 242 patients (38%), with 27% mortality; this included early emergency laparotomy in 32 patients (5%), with 78% mortality. Patients with longer times between admission and intervention had lower mortality: 0 to 14 days, 56%; 14 to 29 days, 26%; and >29 days, 15% (P<.001). A total of 208 patients (33%) received interventions for infected necrosis, with 19% mortality. Catheter drainage was most often performed as the first intervention (63% of cases), without additional necrosectomy in 35% of patients. Primary catheter drainage had fewer complications than primary necrosectomy (42% vs 64%, P=.003). Patients with pancreatic parenchymal necrosis (n=324), compared with patients with only peripancreatic necrosis (n=315), had a higher risk of organ failure (50% vs 24%, P<.001) and mortality (20% vs 9%, P<.001). CONCLUSIONS: Approximately 62% of patients with necrotizing pancreatitis can be treated without an intervention and with low mortality. In patients with infected necrosis, delayed intervention and catheter drainage as first treatment improves outcome.

Stomal mucocutaneous dehiscence as a complication of a dynamic wound closure system following laparostomy: a case report.

Dynamic retention suture techniques that allow gradual reapproximation of abdominal midline muscles and fascia as well as sufficient freedom of movement for breathing and patient care commonly are used to prevent lateral retraction of the abdominal fascia in patients whose abdominal wound closure must be delayed. A 58-year-old otherwise healthy man was admitted with severe abdominal sepsis and following surgery, which included the creation of a stoma, a dynamic wound closure system was applied. Mucocutaneous stomal dehiscence was observed a few days after starting the treatment. The complication was believed to have occurred as a result of traction on the proximal end of the stoma (the bowel inside the abdomen) due to tension on the sutures of the small part of the bowel outside the abdomen. Definite, primary closure of the abdominal fascia was achieved after 16 days, at which point the stoma was reinserted with good results. Since using a modified procedure that involves cutting a groove in the protective drape and carefully placing two flaps around the stoma, this complication has not been observed with similar patients in the authors' facility. This complication is not unique to this wound closure system; it also has been reported with other treatment modalities such as negative pressure wound therapy. The relatively small number of patients requiring delayed closure of the abdomen, coupled with the uniqueness of each case due to a wide variety of indications and comorbidities, hampers the development of evidence-based guidelines of care for these patients. A worldwide data exchange that includes patient experiences and descriptions of successful and failed attempts to address problems and complications in these patients is necessary. In the meantime, experiences with these types of wounds need to be shared in the literature.

A step-up approach or open necrosectomy for necrotizing pancreatitis.

BACKGROUND: Necrotizing pancreatitis with infected necrotic tissue is associated with a high rate of complications and death. Standard treatment is open necrosectomy. The outcome may be improved by a minimally invasive step-up approach. METHODS: In this multicenter study, we randomly assigned 88 patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue to undergo primary open necrosectomy or a step-up approach to treatment. The step-up approach consisted of percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy. The primary end point was a composite of major complications (new-onset multiple-organ failure or multiple systemic complications, perforation of a visceral organ or enterocutaneous fistula, or bleeding) or death. RESULTS: The primary end point occurred in 31 of 45 patients (69%) assigned to open necrosectomy and in 17 of 43 patients (40%) assigned to the step-up approach (risk ratio with the step-up approach, 0.57; 95% confidence interval, 0.38 to 0.87; P=0.006). Of the patients assigned to the step-up approach, 35% were treated with percutaneous drainage only. New-onset multiple-organ failure occurred less often in patients assigned to the step-up approach than in those assigned to open necrosectomy (12% vs. 40%, P=0.002). The rate of death did not differ significantly between groups (19% vs. 16%, P=0.70). Patients assigned to the step-up approach had a lower rate of incisional hernias (7% vs. 24%, P=0.03) and new-onset diabetes (16% vs. 38%, P=0.02). CONCLUSIONS: A minimally invasive step-up approach, as compared with open necrosectomy, reduced the rate of the composite end point of major complications or death among patients with necrotizing pancreatitis and infected necrotic tissue. (Current Controlled Trials number, ISRCTN13975868.)

Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868].

BACKGROUND: The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. METHODS/DESIGN: 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. DISCUSSION: The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.