PRESENTATIONThe Clavien classification system to optimizethe documentation of PCNL morbidity.Jorge Rioja Zuazu 1 , Marcel Hruza 2 , Jens J. Rassweiler 2 ,Jean J.M.C.H. de la Rosette 11 Department of Urology, AMC University Hospital, Amsterdam, The Netherlands;2 Department of Urology, Klinikum Heilbronn, Akademisches Lehrkrankenhaus der Universität Heidelberg,Germany<strong>Summary</strong>High success rates exceeding 90% are reported with <strong>per</strong>cutaneous nephrolithotomy(PNL) and modifications have further decreased the morbidity while maintaining efficacy.However, complications after or during PNL may occur with an overall complicationrate of up to 83%. Although results from several large series on PNL from outstandingcenters are reported in the literature, there is still no consensus on how todefine complications and stratify them by severity. Ham<strong>per</strong>ing comparison of outcome data maygenerate difficulties in informing the patients about the severity of PNL complications.We therefore may conclude that standardization of complications of a certain procedure is necessaryto allow comparison of outcomes between different centers, within a center over time, orbetween different instruments used and/or o<strong>per</strong>ating techniques.In 1992, Clavien et al proposed general principles to classify complications of surgery based ona therapy-oriented, 4-level severity grading, allowing identifying most complications and preventingdown rating. The Clavien Classification system differentiates in five degrees of severityupon the intention to treat. Several Urological teams have studied the use of classificationssystems to document and grade outcomes and morbidity of interventions in urology.Also the modified Clavien system has been applied in urological surgery. Urologists have beenusing this classification to grade <strong>per</strong>io<strong>per</strong>ative complications following laparoscopic radicalprostatectomy, laparoscopic live donor nephrectomy, and retro<strong>per</strong>itoneoscopy. In the field ofendourology, it has been recently applied to PCNL procedures as well, allowing comparisonamong different series between different hospitals and within the same center.Other benefits that the standardization of the complications by using the Clavien System allowsis to give better information to the patient and, assisting them on making the correct therapeuticalchoice. There may also be a benefit for the health insurance bodies to obtain adequateinformation of the procedure, and the results achieved by a team.Besides all its benefits, the modified Clavien system was proposed as a grading system for <strong>per</strong>io<strong>per</strong>ativecomplications in general surgery and there are some limitations in classifying PCNLcomplications. A graded classification scheme for reporting the complications of PCNL may beuseful for monitoring and reporting outcomes. There are some limitations in classifying PCNLcomplications. Minor modifications, especially concerning auxiliary treatments, are needed.Further studies are awaited for the development of an accepted classification system applicableto all urologic procedures.KEY WORDS: Percutanous Nephrolithotomy; Complications; Classification.Submitted 9 May 2009; Accepted 30 June 2009A growing demand for health care, rising costs, constrainedresources, and evidence of variations in clinicalpractice have triggered interest in measuring andimproving the quality of health care delivery. For a valuablequality assessment, relevant data on outcome mustbe obtained in a standardized and reproducible mannerto allow comparison among different centers, betweendifferent therapies and within a center over time.Objective and reliable outcome data are increasinglyrequested by patients and payers (government or privateinsurance) to assess quality and costs of health care. Tostandardize the complications of a certain procedure is20Archivio Italiano di Urologia e Andrologia 2010; 82, 1
The Clavien classification system to optimize the documentation of PCNL morbiditynecessary to allow comparison of different centers, comparisonwithin a center over time, between differentinstruments and/or o<strong>per</strong>ating techniques. Moreover,health policy makers point out that the availability ofcomparative data on individual hospital’s and physician’s<strong>per</strong>formance represents a powerful market force, whichmay contribute to limit the costs of health care whileimproving quality.Traditionally, surgical series upon different procedureshad been compared in between them regarding o<strong>per</strong>ativetime, surgical complications and recovery after procedures.The lack of standardization was one of the factswhich make a comparison difficult. To improve thiscomparison and standardization the medical communityhas been seeking for classification systems too.In 1992, Clavien et al. proposed general principles toclassify complications of general surgery based on a therapy-oriented,4-level severity grading (1). Although thatclassification was used by some others groups, andserved as the basis to assess the outcome of living relatedliver transplantation in the United States, it was notwidely used in the surgical literature because of its limitations.In 2004 the same group proposed a modified classification(2), which allows identification of most complicationsand prevents down-rating of major negative outcomes.This new classification has been widely acceptedand applied throughout different countries and surgicalcultures. It differentiates in five degrees of severity uponthe intention to treat, ranging from 0, which means “nocomplications”, to 5, which means “death” (Table 1).High success rates exceeding 90% are being reportedwith <strong>per</strong>cutaneous nephrolithotomy (PCNL) and modificationshave further decreased the morbidity while maintainingefficacy. However, complications after or duringPCNL may occur with an overall complication rate of upto 83%, including urinary extravasation (7.2%), bleedingnecessitating transfusion (11.2-17.5%), and posto<strong>per</strong>ativefever (21-32.1%), whereas major complications,such as septicemia (0.3-4.7%) and colonic (0.2-0.8%) orpleural injury (0.0-3.1%) are rare (3). Co-morbiditiessuch as renal insufficiency, diabetes, morbid obesity, orcardiopulmonary diseases increase the risk of complications.Although results from several large series on PCNLfrom outstanding centers are reported in the literature,there is still no consensus on how to define complicationsand stratify them by severity. Ham<strong>per</strong>ing comparisonof outcome data generates difficulties in informingthe patients about PCNL complications.The modified Clavien system has been recently appliedin urological surgery. Urologist have been using this classificationto grade <strong>per</strong>io<strong>per</strong>ative complications followinglaparoscopic radical prostatectomy, laparoscopic livedonor nephrectomy, and retro<strong>per</strong>itoneoscopy (4, 5). Theuse of standardized classification systems, such as theClavien System allows comparing results achieved withdifferent techniques and within different centers. It alsodescribes some other results besides the complications,such as the learning curve of a procedure.In the field of endourology, it wasn’t until 2008 whenTefekli et al. (6) reported on this system for <strong>per</strong>cutaneoussurgery for the first time. Their results showed that gradeII complications were the most commonly observed onesafter PNL. Bleeding necessitating blood transfusion wasthe most frequent individual complication, observed in11% of cases. Complications stratified as grade 1 and 2in that series, were considered as minor, while grade 3,4, and 5 were considered major according to other classificationsystems. However, the modified Clavien systemis more objective and reproducible, representing a compellingtool for quality assessment.It was de la Rosette et al. (7) who were able to use it as aTable 1.Meaning of the different grades among the modified Clavien System and its example in PCNL surgery.GRADE Meaning Complications in Urology (PCNL)0 No complications No complicationsI Deviation from normal posto<strong>per</strong>ative course without Fever, Transient elevation of serum creatininethe need for interventionII Minor complications requiring intervention Blood transfusion, Urine leakage < 12 h, Infections requiring additionalantibiotics (instead of prophylactics), Wound infection,Urinary tract infection, PneumoniaIIIa Complications requiring intervention without general Double-J stent placement for urine leakage > 24 h, Double-J stentanesthesiaplacement for UPJ and pelvis injury, Urinoma, Pneumothorax,Retention and colic due to blood clotsIIIb Complications requiring intervention with general anesthesia Ureter-bladder stone, Calyx neck stricture, UPJ obstruction, AV fistula,Perirenal hematoma needing intervention, Perinephritic abscess,Perio<strong>per</strong>ative bleeding requiring quitting the o<strong>per</strong>ationIVa Life threatening complications requiring IC management Neighboring organ injury, Myocardial infarction, Nephrectomy, Lung failure(single organ dysfunction)IVb Life threatening complications requiring IC management Urosepsis(multiple organ dysfunction)V Death DeathArchivio Italiano di Urologia e Andrologia 2010; 82, 121
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