ABSTRACT
Standardization is important for the assessment of technical difficulty and complications in laparoscopic urology surgery. In this study, our laparoscopic operations and complications were evaluated retrospectively by using the European Scoring System and Clavien classification system.
We evaluated a total of 228 laparoscopic urologiy procedures performed between 2002 and 2007. The first 114 cases were named as group 1 and the second 114 cases as group 2. Both of the groups were classified regarding technical difficulty according to the European Scoring System. Complications were divided into two groups: major and minor. Postoperative complications were evaluated by the Clavien classification system.
The rate of difficult operations was 24.5% and 56.1% in group 1 and group 2, respectively. In group 1, major and total complications were more common in difficult operations than in easy operations (p=0.045, p=0.006). Minor complications were similar (p=0.064). In group 2, complication rates were similar for both difficult and easy operations. (p=0.694, p=0.509, p=0.273). Complication rates per case was 0.21 (0-3) in group 1 and 0.19 (0-3) in group 2 and there was no significant difference between the two groups (p=0.790). Postoperative complications were classified using the Clavien classification system. 17% (n=4/23) of 23 complication was grade 1, 48% (n=ll/23) was grade 2, 26% (n=6/23) was grade 3a, 9% (n=2/23) was grade 3b. There were no grade 4 and 5 complications. 3% of the cases were converted to open surgery and no statistically difference was found between the groups (p=0.446).
We assume that the European Scoring System and the Clavien classification system are important in the assessment of difficulty of the cases and standardization of the analysis of postoperative complications.
Introduction
Laparoscopic applications in urology has started with pelvic lymph node dissection in 1991 and had a wide area of usage increasingly in the following years (1). The evaluation of the laparoscopic surgical approaches for the degree of difficulty has been done via the European Scoring System (ESS) (2). Thus, the standardization of laparoscopic surgical procedures and the objective assessment of complications were hoped to be provided. Although they are less invasive applications, it must be kept in mind that laparoscopic surgeries are major surgical applications which may have very serious complications (3). Postoperative complications have been categorized according to the length of hospitalization period until now (4). The median duration of hospital stay is not used for evaluation nowadays because it varies between different clinics and, instead of that, evaluation is being done objectively by a postoperative complication scoring system which was published in 1992 and validated in 2004 by Clavien et al. (5,6). In this article, 228 urological procedures performed in our clinic were assessed using the ESS, while the complications were classified according to the Clavien classification system and the results were evaluated retrospectively.
Materials and Methods
A total of 228 laparoscopic urology procedures performed in our clinic between 2002 and 2007 were evaluated. Group 1 included 114 cases operated between January 2002 and June 2005, and group 2 included 114 cases operated between July 2005 and December 2007. Both groups were classified according to the ESS (2). By using this classification system, easy and mild difficult surgical procedures were all named as easy operations (EO); whereas the pretty difficult, difficult and highly difficult operations were named as difficult operations (DO). Complications were classified as major and minor. While the major complications were accepted as complications that needed significant additional treatment and hospitalization more than 2 days (Clavien grade 3-5); minor complications were considered as ones that needed minimal additional treatment and hospitalization not more than 2 days (Clavien grade 1-2) (7). Postoperative operations were also classified by the Clavien classification system. This classification included 7 groups; grade 1: No need for additional treatment; grade 2: Need for medical treatment including blood transfusion and total parenteral nutrition; grade 3: Need for endoscopic surgery and radiological intervention (grade 3a: no need for general anaesthesia, grade 3b: need for general anaesthesia); grade 4: need for intensive care-life threatening (grade 4a: single organ disorder including hemodialysis, grade 4b: multi-organ disorder); grade 5: death due to the complications (6).
Analysis of data was performed via SPSS 11.5 program. Descriptive statistics were expressed as mean ± standard deviation (minimum-maximum); for continuous variables and nominal properties were expressed as number of cases and as percentage (%). The significance of the difference between the groups due to the mean ages were assessed by student’s t-test; operation difficulty score and the significance of the difference due to complication number per each case were evaluated via the Mann-Whitney U test. Whether there was a statistically significant difference or not between the groups considering nominal features were assessed by using chi-square test or Fisher’s exact probability test. A p value of less than 0.05 was considered statistically significant.
Results
The mean age of the group 1 and the group 2 was 42.2±22.95 years (1-82) and 41.8±21.72 years (2-78), respectively. There was no statistically difference in mean age and gender between the groups (p=0.882, p=0.412, respectively) (Table 1). A statistically significant difference was detected in ESS score range and mean score per unit case between the groups (p<0.001) (Table 1). Details of the ESS distribution of group 1 and group 2 are demonstrated in Table 2. While 24.5% of the operations in group 1 were DO (n=28/114), this rate was 56.1% (n=64/114) in group 2 (Figure 1). Classification of major and minor complications are shown in Table 3. According to detailed analysis of group 1 and group 2 regarding complications; when the number of cases with major and total complications were investigated from the aspect of EO and DO, the number of cases with DO was found to be significantly larger in group 1 (p=0.045, p=0.006, respectively). However, minor complications in the same group were similar regarding DO and EO (p=0.064). When group 2 was investigated considering DO and EO, the number of cases having major, minor and total complications were similar (p=0.694, p=0.509, p=0.273, respectively) (Table 4). In group 2, major complications were detected to decrease compared to group 1; from 10.7% (n=3/28) to 6.3% (n=4/64), however, this result was not found to be statistically significant (p=0.431) (Table 4). In 30 cases from each group, a total of 46 complications were seen. When the two groups were compared for the total number of complications, 24 complications in group 1 and 22 complications in group 2 were recorded. The rate of complications per unit case was found to be 0.21 (0-3) in group 1 whereas it was 0.19 (0-3) in group 2, and no statistically significant difference was detected between the groups (p=0.790). The postoperative complications were classified according to the Clavien scoring system. 17% of 23 complications were (n=4/23) grade 1, 48% (n=11/23) were grade 2, 26% (n=6/23) were grade 3a, and 9% (n=2/23) were grade 3b, while no complication was seen in grade 4 and grade 5 (Table 5). Open surgery was essential in 3% of cases (n=7/228). Five (5) of these cases were in group 1, two (2) cases were in group 2. There was no statistically significant difference between the groups (p=0.446). However, it was important that although DO rate in group 2 was high, the rate of open surgery was decreased.
Discussion
Laparoscopic surgery in urology has been very popular in the past 15 years (8,9,10,11). Nowadays, it is routinely being applied in many health centers in reconstructive and ablative surgery cases (12,13). As a result of long-term experience, various studies comparing laparoscopic surgery to open surgery have been performed and it was suggested that laparoscopic surgery is preferable (14,15). Meanwhile, studies comparing the complications of laparoscopic surgery and open surgery defined no difference between the complication rates (8,16). Until the late 1990s, only complications in specific interventions and low number of cases of complication were reported (11,13,16,17). In recent years, complications with large number of cases and complications of various laparoscopic procedures have been investigated (7,18,19,20). The investigations reporting complication rates in a wide range from 4.4% to 19% have been recently published (10,15,17,21). For example, in two different case series, one with 1769 cases and other with 2966 cases have reported complication rates as low as 1.9% and 0.46%, respectively, however in these series, procedures were particularly easy descriptive interventions (22,23).
By using the ESS, it is possible to evaluate the relationship of laparoscopic surgeries with various difficulty degrees and the complications more comprehensively. For example in a study of 2407 cases with 63% easy and mild difficult cases, the total complication rate was reported as 4.4% (24). Similarly in a study of 350 cases with 67% having particularly easier operations like pelvic lymph node dissection, urinary bladder neck suspension, and varicocelectomy, the complication rate was found to be 5.4% (25). Whereas Colombo et al. reported complications rate of 12.5% in a study of 1867 cases composed of difficult, very difficult and highly difficult procedures (26). Similarly, Parson et al. found a complications rate of 13.2% in a study of 894 cases with 73% difficult and very difficult operations (18). If we had reported the complication rate in our cases without classifying according to ESS, we would face a complication rate of 13%. However, in our cases, complication rate for EO and DO was 8% (n=11/136), and 20% (n=19/92), respectively. There are various opinions and results about complication rates as the experience in laparoscopic surgery increases (18,27). Vallancien et al. suggested that at least 50 difficult cases must be operated to gain the sufficient laparoscopic proficiency, as a conclusion of a study investigating laparoscopic urological complications in 1311 cases and reported that a complication rate of 13.3% in first 100 cases has decreased to a lower degree of 3.6% in latter cases (19). Similarly in a study of 2775 cases, it has been reported that complication cases decreased from 22.1% to 17% despite increasing difficulty (7). Whereas Colombo et al. and Parson et al. found no statistically significant, decrease in complication rates (18,26). In our study, the mean difficulty point per unit case according to the ESS was found to be 8.8 (n=771/114) in group 1, and 11.8 (n=1039/114) in group 2. This result was statistically significant (p<0.001). Despite the larger number of very difficult operations in group 2, total complication rates were similar between the groups (12.3%, 14%) (p=0.695). Although major complication rates in group 1 and group 2 for DO values decreased from 10.7% (n=3/28) to 6.3% (n=4/64), this decrease was not found to be statistically significant (p=0.431) (Table 4).
The Clavien classification system that was validated in 2004 is recently being used to describe the serious complications and to standardization of evaluation for postoperative complications (6,20,28,29). Exclusion of the intra-operative complications has been reported to be the disadvantage of this classification (30). Perpomb et al. have suggested modification of the Clavien system to include intraoperative complications (7). Teber et al. have found that the complication rate for grade 3a was higher as 1.8% (n=13/692) (20). Grade 3a and higher postoperative complications were found as 3.5% (n=8/228) in our study. The port sites, including fascia were closed surgically. Nevertheless, port hernia cases were repaired with local anaesthesia. In our study, there was no death due to surgery.
Vessel injury is reported to be the most common complication during peroperative dissection (25,31,32). Teber et al. reported vessel injury rate as 1.7% and organ injury rate as 0.25% (20). In our study, vessel injury rate was 3.5% (n=8/228), and organ injury rate was 0.87% (n=2/228). In a study performed in 2007, converting to open surgery during laparoscopic urological procedures was considered to be a major complication (20). In some studies, need for open surgery was not regarded as a complication, thus, it was not included in complication group (26,33). Also in our study, converting to open surgery was not considered a complication. Totally, 7 patients (3%; n=7/228) have undergone open surgery. Four (4) of these 7 cases were in group 1, and 3 in group 2. The reasons for open surgery were vessel injury (vena cava, renal vein) in 2 cases, colon perforation in 1 case, and prolongation of operation time due to technical and experience deficiency in 4 cases. Colon injury was repaired by peroperative open surgery. Colonic fistula in postoperative period healed spontaneously following short-term slow drainage. There are studies reporting open surgery rates of 0.09%, 1.4% and 2.7% in the literature (7,20,26). Several studies have reported that laparoscopic intervention was applied for many complications occurring during the operation (34). These results are supported by many studies with the rates of converting to open surgery decreasing from 28% to 0% values (24,34). In our cases, 8 cases had serious vessel injury and 6 of them were solved by laparoscopic restoration.
Laparoscopic surgery has been recommended for many urological procedures nowadays. Although it is less invasive, the fact that it is still a major surgery should be kept in mind. In many centers, although highly difficult cases are being operated, it was reported that the complication rates are decreasing and successful results are being obtained as the experience is increasing. We also did not detect any increase in complication rates because of the increase in our surgical experience. We suggest that the European Scoring System and Clavien classification are important for the evaluation of difficulty degrees of cases and to provide standardization for accurate analysis of postoperative complications.
Ethics Committee Approval: We dont think it necessary for Ethics Committee approval and informed consent by reason of our study is a retrospective evaluation.Concept: Fuat Demirel
Design: Murat Topcuoğlu
Data Collection or Processing: Murat Topcuoğlu
Analysis or Interpretation: Fuat Demirel
Literature Search: Murat Topcuoğlu, Fuat Demirel
Writing: Fuat Demirel, Murat Topcuoğlu
Peer-review: Externally peer-reviewed.
Conflict of Interest: No conflict of interest was declared by the authors.
Financial Disclosure: The authors declared that this study has received no financial support.
