Supplementary Appendix
This appendix has been provided by the authors to give readers additional information about their work. Supplement to: van Santvoort HC, Beslink MG, Bakker OJ, et al. A step-up approach or open necroctomy for necrotizing pancreatitis. N Engl J Med 2010;362:1491-502.
traci binghamSupplementary appendix to manuscript:ahp
A step-up approach or open necroctomy for necrotizing pancreatitis
METHODScomfort
bios是什么意思Minimally invasive step-up approach
Step 1: percutaneous or endoscopic drainage
A percutaneous drain was placed in the peripancreatic collection under guidance of CT or ultrasound (step 1a). Minimal drain size was 12-French and multiple drains were allowed. The preferred route was through the left retroperitoneum, thereby facilitating minimally invasive retroperitoneal necroctomy at a later stage. Transabdominal drainage was performed if a retroperitoneal access route for drainage w
as not possible. Details on the percutaneous drainage procedures and irrigation protocol have been described elwhere.1 Only if neither retroperitoneal nor transabdominal drainage was possible, was endoscopic transgastric drainage performed. For the endoscopic drainage procedures, the collections were punctured with a 19 Gauge needle (Cook). A standard 0.035 inch guidewire was introduced through the needle into the collection, after which the needle was removed. Over the guidewire the outside sheet of a 7 Fr cystotome (Cook) was introduced into the collection using cutting current. Thereafter the tract was dilated with a 8-mm Maxforce dilation balloon (Boston Scientific). Thereafter, 2 double-pigtail plastic stents (7 French, 4 or 5 cm) and a nasocystic catheter were placed in the infected collection. For irrigation the drains were flushed with a bolus of 250 cc of normal saline four times a day.
空军工程大学分数线免费少儿英语学习网The next treatment step depended on whether or not the patient’s condition improved.
C linical improvement was defined as follows: 1) on ICU: improved function of at least two organ systems (i.e. circulatory, pulmonary, renal) and 2) on the ward: at least 10% improvement of two out of three of the following parameters: temperature, white blood cell
count and C-reactive protein. In abnce of clinical improvement after 72 hours, CT was repeated. If
the position of the drain(s) was inadequate or other collections could be drained, a drainage procedure was repeated once (step 1b) with reasssment after the next 72 hours, if not; minimally invasive necroctomy was the next step (step 2).
If at any moment after the first and cond 72 hours following percutaneous drainage, a patient who initially stabilized failed to show further clinical improvement or even clinically deterioration (according to the predefined criteria), minimally invasive necroctomy was also performed.
Step 2: minimally invasive retroperitoneal necroctomy
Video-assisted retroperitoneal debridement (VARD) was performed via a 5 cm incision according to the previously published technique.2,3Using the retroperitoneal drain for guidance, only looly adherent necrosis was removed from the collection with videoscopic assistance after which two large bore drains were inrted. If VARD was technically not possible, (i.e. no retroperitoneal access route), laparotomy was performed according to the technique ud in the open necroctomy group.
Postoperative management
Continuous postoperative lavage amounting up to at least 10 L per 24 hours on the third postoperati妥协是什么意思
polyethyleneve day was performed both after open necroctomy and VARD. All patients underwent contrast-enhanced CT one week after randomization. Other CT scans were performed on demand. Reinterventions for persisting psis or complications were performed on demand and, if possible, in accordance with the strategy the patient was initially assigned to. All patients received intravenous antibiotics (imipenem/ cilastatin, meropenem or
piperacillin/tazobactam depending on treatment center) after randomization, which were switched according to culture results. Nutritional support was also standardized.1
Costs
tuesday是什么意思Cost-minimization analysis was ud to determine economic differences between the minimally invasive step-up approach and primary open necroctomy. Costs were estimated from a societal perspective.4 Direct medical costs and indirect costs related to abnce from work were estimated during admission and 6 months follow-up. Primary data were ud to asss the u of health care resources. In addition, at 3 and 6 months after discharge, patients filled out the validated Health and Labor questionnaire5and a diary to capture additional resource u. Costs were assd according to the Dutch guidelines for (pharmaco-)economic rearch.6 Guideline unit costs were ud for ICU
stay, hospital stay, medication (i.e. antibiotics during admission and antidiabetic medication and pancreatic enzymes during follow-up), visits to primary and outpatient health care clinicians, home care and admission to rehabilitation centers or nursing homes.6,7 Unit costs for operations, radiological procedures, endoscopic procedures and microbiology diagnostics were calculated at one of the university hospitals in 2008 and included all personnel costs, costs of materials, costs of equipment, and overhead costs. Productivity loss due to abnce from paid work were calculated according to the cost friction method.8Costs per patient were calculated by multiplying volumes of resource with unit costs.4 All costs were t at the year 2008 price level using the price index rate of the Dutch health care ctor.
Statistical analysis
The original study protocol1 stated that, for safety reasons, continuous quential monitoring would be performed on mortality and major morbidity included in the primary endpoint.An
independent biostatistician who was blinded for treatment allocation performed continuous quential analysis on mortality and major morbidity reported during the trial. The analysis was performed with PEST (PEST 4: ur manual. MPS Rearch Unit (2000), the University of Reading)
according to the restricted procedure as described by Whitehead.9,10 The boundaries for the quential analysis plot were bad on the assumption that the minimally invasive step-up approach would reduce the occurrence of the primary endpoint from 45% to 16%, with 80% power and a two-sided alpha level of 0.05. A conventional sample size analysis yielded a total study population of 88 patients.
席慕容一棵开花的树
If one of the boundaries of the quential analysis plot was crosd during the analysis of the cumulative data, meaning that the difference in treatment was of at least the predefined expected magnitude (in either direction), the biostatistician would inform the independent monitoring committee which would advi the steering committee on continuation or termination of the study. If the boundaries would not be crosd during the study, the trial would continue until the total of 88 patients was randomized. The prespecified boundaries guarantee the type I error wherever they are crosd.
The prespecified boundaries were not crosd during the period of patient enrollment and conquently the independent monitoring committee and the steering committee were not informed of results of the quential analysis. The outcome of the quential analysis was only known to the independent biostatistician.
Early on in the trial it became apparent that the quential analysis suffered from significant delay becau only data on mortality and evident major morbidity reported by local investigators could be nt to the biostatistician, whereas a patient could only be analyzed as not having an endpoint once the follow-up period of 3 months after discharge was completed and data collection was complete. Moreover, it was anticipated that, once the data were checked by the independent auditor, morbidity endpoints could be found in patients who
