|Year : 2016 | Volume
| Issue : 1 | Page : 33-40
Prospective evaluation of complications in laparoscopic urology at a mid-volume institution using standardized criteria: Experience of 1023 cases including learning curve in 9 years
Oner Sanli, Tzevat Tefik, Selcuk Erdem, Mazhar Ortac, Emre Salabas, Serkan Karakus, Baris Yucel, Abubekir Boyuk, Tayfun Oktar, Faruk Ozcan, Necdet Aras, Murat Tunc, Ismet Nane
Department of Urology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
|Date of Submission||01-Aug-2014|
|Date of Acceptance||09-Oct-2014|
|Date of Web Publication||17-Dec-2015|
Istanbul Faculty of Medicine, Istanbul University, Cerrahi Monoblok 1. Kat, 34093, Capa, Fatih, Istanbul
Source of Support: None, Conflict of Interest: None
Aim: To evaluate the laparoscopic operations performed in our department according to the modified Clavien classification system of complications. Materials and Methods: Between September, 2005 and February, 2014, a total of 1023 laparoscopic cases were performed. This period was divided into three terms (Terms 1, 2 and 3 consisting of 38, 32 and 32 months, respectively). According to the European Scoring System (ESS), easy (E), slightly difficult (SD), fairly difficult (FD), difficult (D), very difficult (VD) and extremely difficult (ED) cases were 35, 88, 170, 390, 203 and 137, respectively. The perioperative complications were evaluated based on the 3 time periods, with a specific emphasis on determining the learning curve according to the modified Clavien classification system of complications. Results: A total of 236 (23.1%) complications were observed according to the modified Clavien classification. The minor (Clavien I-II) and major (Clavien III, IV and V) complication rates were 20.5% (n = 210) and 2.4% (n = 26), respectively. Clavien I was the most frequently encountered type of complication (n = 120, %11.7). No significant difference was observed among all 3 time periods regarding total complication rates. The D cases had the highest complication rate compared to E, SD, FD, VD and ED cases among all three terms. The total number of complications increased significantly with increasing grade of technical difficulty according to the ESS. Conclusion: Complications encountered in our laparoscopic surgery experience were predominantly minor, and the rate of complications was not significantly increased during the learning curve. The present data can provide guidance and manage expectations for surgeons introducing laparoscopy into their practice.
Keywords: Complications, laparoscopy, urology
|How to cite this article:|
Sanli O, Tefik T, Erdem S, Ortac M, Salabas E, Karakus S, Yucel B, Boyuk A, Oktar T, Ozcan F, Aras N, Tunc M, Nane I. Prospective evaluation of complications in laparoscopic urology at a mid-volume institution using standardized criteria: Experience of 1023 cases including learning curve in 9 years. J Min Access Surg 2016;12:33-40
|How to cite this URL:|
Sanli O, Tefik T, Erdem S, Ortac M, Salabas E, Karakus S, Yucel B, Boyuk A, Oktar T, Ozcan F, Aras N, Tunc M, Nane I. Prospective evaluation of complications in laparoscopic urology at a mid-volume institution using standardized criteria: Experience of 1023 cases including learning curve in 9 years. J Min Access Surg [serial online] 2016 [cited 2020 Jul 10];12:33-40. Available from: http://www.journalofmas.com/text.asp?2016/12/1/33/158154
| ¤ Introduction|| |
The increased complexity of health care has led to soaring costs and strained resources. Greater efficiency and more cost-effective strategies have become necessary on an institutional and system-wide basis. This situation has initiated a growing interest in the quality of surgical work, an initiative that is swiftly being adopted by governments, insurance companies and hospitals. 
Mortality and morbidity are arguably the most critical measures.  A direct cause-and-effect relationship between surgery and complications is often difficult to evaluate, and in order to assess a complication, an accurate definition is mandatory.  Sokol and Wilson defined complication as "any undesirable, unintended and direct result of an operation affecting the patient, which would not have occurred, had the operation gone as well as could reasonably be hoped."  To monitor surgical quality, there is a need to compare complications in an objective and standardized form. Martin et al. introduced the criteria that should be used, when reporting complications, and Clavien and Dindo proposed a grading system of postoperative complications that was re-evaluated and modified. ,
Laparoscopy is a minimally invasive surgical approach used in many major surgeries.  There are significant studies that demonstrate the advantages of laparoscopy, such as decreased blood loss, shorter hospital stay and convalescence, and lower patient morbidity.  Even though both patient and surgeon satisfaction are high with the use of laparoscopy, the incidence and magnitude of complications have increased as more complex procedures are undertaken or attempted laparoscopically.  Expeditious identification and efficient management of complications are of paramount importance, as a delay or lack of recognition may lead to serious patient sequelae and morbidity. 
In the present study, we sought to examine the impact of laparoscopy on perioperative outcomes by examining a consecutive series of patients undergoing minimal invasive surgery at our institution using validated instruments for complication reporting, such as the modified Clavien-Dindo grading system and Martin et al. criteria.
| ¤ Materials and Methods|| |
Between September, 2005 and February, 2014, a total of 1023 laparoscopic cases were performed at our institution. All of the patients' data were prospectively collected using a "Laparoscopic Data Collecting Chart of Istanbul Faculty of Medicine" adopted and modified from the "University of Michigan Laparoscopy Database Chart Abstraction Form," specific for each type of laparoscopic urologic surgery. This chart, in addition to the demographic and the perioperative data, includes complications categorized according to the modified Clavien-Dindo classification of surgical complications. It also includes the comments of the surgeons in cases of deviation from normal or undesirable results of surgery. Moreover, the follow-up data, specific for each type of surgery, are included in the chart. For instance, the chart of laparoscopic partial nephrectomy (LPN), in addition to demographic data, includes the American Society of Anesthesiologists Score, clinical stage of the tumor, RENAL nephrometry score, preoperative aspects and dimensions used for an anatomical score, laterality, surgical technique, ischemia time, operative time, intraoperative complications (cause of bleeding, visceral organ injury, equipment malfunction, method of repair) estimated blood loss, hemoglobin and hematocrit drop, hospital stay, modified Clavien-Dindo complications on follow-up and oncology follow-up. Similarly, all charts are specifically modified for each operation. The charts fully meet the Martin et al. criteria of complications. ,,
The laparoscopic procedures were diverse and classified by the degree of technical difficulty according to the European Scoring System (ESS).  Procedures not included in the ESS were classified according to the report of the primary surgeon's (OS) criteria, such as technical difficulty and operative time. The radical cystectomy operation, not included in the ESS, was added to the "extremely difficult" (ED) group. Excision of retroperitoneal liposarcoma and ureteroneocystostomy were categorized in the "very difficult" (VD) group. Procedures such as uretero-ureterostomy, pyelolithotomy, pyeloplasty and pyelolithotomy, ureterolysis, excision of local recurrence, bladder rupture repair and lymphocele fenestration in renal transplant patients were considered as "difficult" operations (D). Finally, obturator lymphadenectomy and retroperitoneal biopsy were considered among the "fairly difficult" (FD) operations. In total, eight surgeons performed the 1023 laparoscopic operations, with a leading surgeon performing, attending or mentoring ≈ 90% of the cases (OS). Minor complications were defined as Clavien I and II and major complications as Clavien IIIa, IIIb, IVa, IVb and V. The cases were compared regarding the complications in three different time periods. The first period was from the beginning of the laparoscopy program until training of the program director (OS) for extremely difficult operations under a mentor in a different institution (September, 2005-October. 2008; 38 months, Term 1, n = 126). The 2 nd and 3 rd periods were the first and second periods after training ([November, 2008-June, 2011; 32 months, Term 2, n = 418], [July, 2011-February, 2014; 32 months, Term 3, n = 479]). Differences between complication rates were analyzed by Chi-square tests in which P < 0.05 was considered to be statistically significant.
| ¤ Results|| |
A total of 236 (23.1%) complications were encountered among 1023 laparoscopic procedures [Table 1]. The number of cases with Clavien I, II, IIIa, IIIb, IVa, IVb and V complications were 120 (11.73%), 90 (8.8%), 7 (0.68%), 10 (0.98%), 3 (0.29%), 1 (0.1%) and 5 (0.49%), respectively. Minor complications were encountered in 210 cases (20.5%), whereas major complications were observed in 26 procedures (2.5%). The distribution of total, minor and major complications are shown in [Table 1]. The details of the patients with major complications are shown in [Table 2].
The annual case volume and complication rates are shown in [Figure 1]a and b, respectively. The number of cases regarding the degree of technical difficulty in the three terms is shown in [Figure 2]. There was a significant increase in the number of VD cases through Term 1, Term 2 and Term 3 with rates of 4%, 15.3% and 28.0%, respectively (P < 0.0001). The easy (E), D and ED cases did not differ among terms, whereas there was a notable decrease in the SD and FD cases. The variety of the operations changed over the years as follows; 2 in the year 2005, 4 in 2006, 8 in 2007, 13 in 2008, 15 in 2009, 19 in 2010 and 2011, 15 in 2012 and 12 in 2013 and 2014. The distribution of complications according to the Modified Clavien-Dindo classification through the terms is shown in [Figure 3]. Although the total number of complications tended to decrease in Terms 1, 2 and 3, no significant difference was observed among all three terms, with total complication rates of 24.6%, 25.8% and 20.3%, respectively. Similarly, no significance was observed in the minor and major complications as compared over the three terms.
|Figure 2: Distribution of cases according to the technical difficulty of ESS in the Terms 1, 2 and 3. E: Easy, SD: Slightly difficult, FD: Fairly difficult, D: Difficult, VD: Very difficult, ED: Extremely difficult, ESS: European Scoring System|
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|Figure 3: Modified Clavien-Dindo classification of surgical complications through the Terms 1, 2 and 3|
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Moreover, among the patients with complications, D cases had the highest complication rate with 94 cases (P = 0.001) regarding all three terms, which was a statistically significant difference. Furthermore, the complication rates of D and ED cases were significantly higher in Term 2 as compared to Term-1 and 3 (D cases, [Term 1: 13/94 (14%), Term 2: 45/94 (48%), Term 3: 36/94 (38%)], P = 0.001, ED cases [Term 1: 8/53 (15%), Term 2: 31/53 (59%), Term 3: 14/53 (26%)], P = 0.001). However, the complication rate of VD cases was significantly higher in Term 3 as compared to Terms 1 and 2 (VD cases, Term 1: 1/50 (2%), Term 2: 15/50 (30%), Term 3: 34/50 (68%), P = 0.001).
In further analyzes, the total number of complications increased significantly with the increasing grade of technical difficulty according to the ESS (complication rate; E: 8.6%, SD: 4.5%, FD: 18.8%, D: 24.1%, VD: 24.6%, ED: 38.7%, P < 0.0001). A similar pattern was observed in the minor and major complications regarding the ESS grade of difficulty.
| ¤ Discussion|| |
Implementation of laparoscopy as an alternative to open surgery has increased in the last decade due to the prevention of large access and the perioperative trauma, comparable oncologic and functional outcomes and patient preference.  Although some procedures such as laparoscopic radical nephrectomy for the management of T1-2 renal cell carcinoma have become the standard of care, other more complex techniques have demonstrated feasibility and are still evolving. 
In the present study, we report a 23.1% rate of total complications with 20.5% and 2.5% of minor and major complication rates, respectively. Colombo et al. reported a 12.4% rate of total complications in a large series of 1867 laparoscopic oncologic procedures, with 3.5% intraoperative and 8.9% postoperative.  Comparably, Cadeddu et al. reported an overall complication rate of 11.9% after concentrated training in laparoscopy.  Liapis et al. reviewed 600 retroperitoneoscopic cases of the upper urinary tract and reported a total complication rate of 9.9%.  Laparoscopic complication rates vary from 4.4% to 22.6% in other literature. , Many other authors, including Permpongkosol et al., Inoue et al. and Rassweiler et al., have classified their procedures according to the standardized Clavien criteria of postoperative complications. ,, In a large multicenter cohort of 2775 laparoscopic surgeries, Permpongkosol et al. reported a 22.1% rate of total complications.  Complication rates of Clavien grades I, II, IIIa, IIIb, IVa, IVb and V were 7.53%, 6.85%, 0.83%, 1.55%, 0.6%, 0.04% and 0.07%, respectively.  A series of laparoscopic cases by Inoue et al. described a 14.6% rate of total complications, with complications of Clavien grades I, II, IIIa, IIIb, IVa, IVb and V with rates of 3.6%, 4.4%, 2.3%, 0.3%, 0.2%, 0% and 0.1%, respectively.  Our complication rates according to the Clavien classification were 11.73%, 8.8%, 0.68%, 0.98%, 0.29%, 0.1% and 0.49% for grades I, II, IIIa, IIIb, IVa, IVb and V, respectively. Our complication rates were slightly higher than those of the reported series in the literature. The incidence of postoperative complications is significantly reduced when the operation is performed in a high volume hospital and by an experienced surgeon.  It has to be mentioned that the literature series describes cases of pioneering surgeons in the field, and we believe that the present report mirrors the real surgical experience of a moderate volume training hospital.
The present report revealed that the overall complications did not increase, even though the variety and difficulty of cases increased over time. The degree of technical difficulty increased over the years, shifting cases of SD and FD primarily to VD cases. Permpongkosol et al. mentioned an increase in the total number of urological laparoscopic procedures over time without an increase in the total number of complications per year during their study period.  In addition, other series reported a decreased risk of complication with an increasing case volume, despite increased technical complexity. , Similarly, Fahlenkamp et al. reported a decreased complication rate from 13.3% for the first 100 procedures to 3.6% subsequently, despite the cases becoming more complex.  However, Inoue et al. described an increase in complication rates and justified their results by noting increased technical difficulty of the cases.  As expected, centers gain experience with time, and more challenging cases are undertaken with increasing experience. We experienced more difficult cases without an increase in complication rates over time.
In subgroup analysis, the number of VD cases increased in Terms 2 and 3 as compared to Term 1, whereas SD cases decreased in Terms 2 and 3 as compared to Term 1. However, complications of VD (highest in the last tem) cases rose as the number of cases increased over time. This increase may reflect the learning curve as faculty started performing VD cases in Term 3. Fahlenkamp et al. described complication rates of 1%, 3.9% and 9.2% for E, moderate and difficult procedures, respectively, and suggested that the complication rate depends on the difficulty of the operation.  Likewise, Inoue et al. reported higher complications with increasing complexity.  Similarly, Colombo et al. described higher complication rates of VD (%23.3) as compared to D cases (13.5%).  Other cohorts mention higher complication rates with increasing difficulty (E: 4.8%, moderate: 9.1%, difficult: 13.7%).  Comparably, our total, minor and major complications increased with the increasing grade of technical difficulty. Conversely, Vallancien et al. did not find a higher complication rate of D and VD operations than that observed in a series of less difficult operations.  Interestingly, we found D cases to have the highest complication rate. This is attributed to the fact that these cases are primarily mentored and performed by novice laparoscopists, whereas the VD and ED cases are mainly those performed by the primary surgeon (OS). Even though many pioneering surgeons report data of increasing complexity without an increase in complications, herein, we present a series of cases with inexperienced surgeons performing more complex VD cases, with increasing complication rates. 
Among the operations being performed by a laparoscopic surgeon, LPN, laparoscopic radical prostatectomy and laparoscopic radical cystectomy (LRC) merit further discussion because of their higher complication rates in the present study. Among these LPN, T1a N0 M0 renal tumors are technically challenging laparoscopic procedures. Bleeding and urinary leakage are the most common major complications.  Simmons and Gill reported a 4.5% rate of hemorrhagic complications and a 2% rate of urinary leak.  Turna et al. described a 5.7% rate of postoperative bleeding and a 2.4% rate of urinary leakage.  Another study revealed 2.7% and 1.9% rates of postoperative hemorrhagic complications and urinary leakage, respectively.  Our series shows a 3.5% (n = 5) rate of postoperative bleeding and a 0.6% (n = 1) rate of urinary leakage requiring intervention. For a postoperative hemorrhagic complication, the severity at presentation determines the management chosen. In our series, one patient required nephrostomy for urinary leakage and one patient was explored due to bleeding on postoperative day 1.
Laparoscopic radical prostatectomy is classified as "extremely difficult" (ED) in the proposal for "ESS for laparoscopic operations in urology."  The overall complication rate is reported to be up to 29.8% in the literature.  The minor and major complication rates are stated as 23.1% and 6.6%, respectively.  We describe a 27.1% (n = 23) overall complication rate with minor and major rates of 25.9% (n = 22) and 1.2% (n = 1), respectively. Budäus et al. demonstrated that high-volume surgeons (>63 minimally invasive radical prostatectomy per year) had a significantly lower risk of overall complications in comparison with those performing <63 cases/year.  Our relatively high complication rate may be explained by the fact that our center performs <63 cases/year. However, it should be noted that the major complication rate was relatively low.
Laparoscopic radical cystectomy is a technically challenging procedure requiring a high level of experience with a steep learning curve.  We report a rate of 61.9% (n = 13) and 14.3% (n = 3) for minor and major complications, respectively. Huang et al. published a series of 171 LRC with rates of 25.7% and 13.5% minor and major complications, respectively.  Similarly, Hemal et al. reported rates of 16.7% and 10.4% minor and major complications, respectively.  Although we had a similar major complication rate for LRC, the minor complication rate was higher. We believe that this outcome was due to the early years of the learning curve and because no selection was made for the cases. Our center, shifted the majority of cases to the open approach after a decision was made by the faculty to perform all radical cystectomies with extended lymph node dissection up to the level of aortic bifurcation. This level of lymph node dissection requires significant time that prolongs the operative period.
In the current study, we present a composite view of complications during a 9 years period in a series of 1023 cases. The strengths of our report include the integration of full Martin et al. criteria and standardized criteria for complications, the modified Clavien-Dindo system, prospective data recruitment, a large and varied number of operations performed over a long period and ≈ 90% attendance of only one surgeon. There are several limitations to this study. When more than 1 complication occurred in a patient, only the most severe was taken into account. Nonetheless, reporting of the complication frequency, rather than the number of patients with one or more complications, as the numerator gives a more accurate reflection of the true severity of complications.  Another limitation is that intraoperative complications that are promptly identified and corrected without any deviation from the normal postoperative course are not graded in the Clavien-Dindo classification system. Despite these drawbacks, it should be noted that the present study reflects results of cases from several different attending surgeons working in an academic training program with fellow and resident case participation.
| ¤ Conclusions|| |
Complication rate in laparoscopy decreases with experience either performing or mentoring the procedures. Awareness of the complication rates of surgery can contribute significantly to the quality of the performed surgery. Understanding the physiology of laparoscopy, patient risk factors, the technical challenges and potential difficulties for each procedure may help to reduce the complication risk. The complications encountered in our laparoscopic surgery experience are predominantly minor and acceptable and reflect a program of a team that does not have extensive experience in laparoscopy and is not in a pioneering center of excellence. Thus, the data could translate to an expected experience for the general community practice, as laparoscopic procedures are increasingly performed outside of academic centers of excellence.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]