Background
No procedure-specific definitions in complication reporting have been universally accepted in urological surgery, and conventional classification systems do not reflect cumulative morbidity.
Objective
To conduct a rigorous assessment of 30-d complications after radical cystectomy and improve morbidity estimates by introducing the novel Comprehensive Complication Index (CCI).
Design, setting, and participants
A retrospective proof-of-concept study of 506 patients with bladder cancer between 2009 and 2017.
Intervention
Radical cystectomy with pelvic lymph node dissection.
Outcome measurements and statistical analyses
Thirty-day complications were extracted from digital charts based on a procedure-specific catalog. Each complication was graded by the Clavien-Dindo classification (CDC), and each individual CCI was calculated. We evaluated traditional morbidity endpoints and tested the ability of both classification tools to mirror cumulative morbidity. Multivariable regression analyses were employed for risk modeling using conventional and novel endpoints. The study fulfilled all the European Association of Urology (EAU) criteria of standardized reporting. Limitations include restricted follow-up of 30 d.
Results and limitations
Of 506 patients, 503 (99%) experienced a total of 2485 complications, of which the majority was classified as “minor” (CDC grade ≤ IIIa; 89%). Overall, 29 (5.7%), 20 (4.0%), and 12 (2.4%) patients were reoperated, readmitted, and died within 30 d, respectively. When using the CCI to capture cumulative morbidity, the proportion of patients with most severe complication burden (CDC grade ≥ IIIb or corresponding CCI > 33.7) increased to 31% as compared with 11% when considering only the highest-grade complication according to the CDC. Age-adjusted comorbidity and delta hemoglobin were the main drivers of perioperative complications for all outcomes in multivariable models.
Conclusions
The assessment of short-term morbidity after radical cystectomy may be refined and optimized by employing the EAU criteria of standardized reporting and using the CCI to capture cumulative morbidity. These are the cornerstones of urgently needed procedure-tailored benchmarking to improve comparability and quality control.
The study by Vetterlein et al. aimed to assess the 30-days complications rates after radical cystectomy and introduced the novel Comprehensive Complication index (CCI) to improve the prognostication of the morbidity associated with the radical cystectomy procedure.
The CCI summarizes all complications into a single formula weighted by their severity, it was used via an online calculator provided on https:// www.assessurgery.com.
The 3 objectives of the study were: to generate a predefined catalog of general and radical cystectomy procedure–specific complications, to conduct a rigorous assessment of 30-d morbidity after RC according to the updated EAU guideline, and to compare the Clavien Dindo Classification (CDC) with the CCI.
Significant deficiencies in complication reporting and underestimation of low-grade complications are apparent in the urological literature. The interobserver variability in grading and assigning complications may be related to procedure-specific variability of complications. Thus, precision and creation of a procedure-specific morbidity spreadsheet is urgently needed in the RC setting to improve the reliability of grading complications according to their severity, particularly when investigating the conventional endpoint overall complications.
For this study they stratified their cohort by comorbidity burden using the age-adjusted Charlson comorbidity index (ACCI) cutoffs, they defined and reported five morbidity key estimates (overall complications, most severe complications CDC grade >IIIb, readmissions, reoperations, and mortality.
Overall, 506 patients were included in the study, among them 2485 complications were reported in 503 patients, which translated in a median of five complications per patient. Not surprisingly, the most common complications were genitourinary (24%), gastrointestinal (19%) and infectious complications (15%). 97% of the patients developed more than one complication within 30days after RC and 34% developed more than five complications. They found 11% of severe complications requiring re-intervention, 4% of patients needing a readmission and 2.4% died during the perioperative period.
Using the CCI tool, 20% of patients were upgraded to most severe complication when calculating their cumulative CCI considering all complications compared with the corresponding CCI considering only the highest complication.
They found significant upgrading of the recorded morbidity in over 20% of patients towards a CCI score of >33.7 corresponding to a CDC grade IIIb often referred to as the threshold of a major or most severe complication. The CCI provides in this study a more intuitive reflection of the perceived overall morbidity. Nevertheless, CCI can’t be the new exclusive tool to assess complications as more evidence-based studies are needed to validated its added value and a significant change over current methodology.
From an academic perspective, CCI should be implemented in future studies in order to obtain an accepted, predefined complication checklist to mitigate extensive subjectivity and bias. Hence, this is definitely a promising tool for future research. Moreover, the EAU quality criteria of standardized reporting is of paramount importance and should be used systematically in the near future for all complications reported after surgeries and especially radical cystectomy.