Introduction
After laparoscopic cholecystectomy was introduced in the early 1990s, an increase in the number of bile duct injuries (BDIs) was noted [1]. A BDI has serious medical, financial, and medicolegal consequences for patients and health-care professionals [2‐4]. Subsequently, additional patient safety interventions were implemented.
A major step toward safe cholecystectomy was the description of the “critical view of safety” (CVS) technique by Strasberg in 1995 [5]. The CVS technique is advocated by virtually all recent guidelines and expert commentaries [6‐9]. The Dutch Society of Surgery issued a best-practice guideline in 2005 endorsing the CVS technique [10]. According to the guideline, CVS is achieved once one third of the gallbladder is dissected off the liver, and the presumed cystic duct and artery are the only structures running from the gallbladder to the hepatoduodenal ligament. The guidelines were promoted through publication and presentation at national conferences; all Dutch surgeons are expected to follow them.
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Another safety intervention is intraoperative cholangiography (IOC). Population-based analyses have shown a reduction in major BDI by 25–39% when IOC is performed [11‐13]. The guidelines of the Dutch Society of Surgery currently do not recommend routine IOC.
It has been suggested that the incidence of BDIs in the Netherlands is higher than in other countries [2]. Numerous papers have been published on preventive measures to take during cholecystectomy, but it remains unclear which safety measures are actually being employed by Dutch surgeons. This study aimed to identify practice of and opinions on the CVS technique and IOC.
Methods
An electronic questionnaire was composed by a panel of five abdominal surgeons and a medical psychologist (Appendix). The survey was completely anonymous. E-mail addresses were obtained of all members of the Dutch Society of Surgery, including surgical trainees, and the electronic questionnaire was sent to all addresses. Two weeks after the first e-mail, one reminder was sent. The study closed for recruitment 2 weeks later.
Hospitals in the Netherlands may be classified as “university teaching” (tertiary referral, specialist training, and medical research), “nonuniversity teaching” (general hospitals licensed to train surgical trainees), or “nonteaching” (general hospitals that do not train surgical trainees). Once deemed sufficiently qualified, surgical trainees may perform cholecystectomies without supervision of a consultant present in operating theater.
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Statistical analysis was performed with SPPS ver. 16.0 for Windows (SPPS Inc., Chicago, IL, USA). Descriptive statistics were used to portray the responses. The accumulated number of cholecystectomies performed by the groups of surgeons was calculated using the median of the self-reported range of cholecystectomies (i.e., 17 for the range of 10–25). In case of >50 cholecystectomies per year, the arbitrarily chosen number of 60 was used. χ2 tests were used to compare the incidence of BDIs in different groups. A P < 0.05 was considered significant.
Results
The electronic survey was successfully delivered to 1206 addresses. There was a 40.4% (487/1206) response rate. Thirty-four surgeons indicated that they no longer performed cholecystectomies. Thus, 453 questionnaires were included for analysis.
Clinical profile
The clinical profile of the respondents is shown in Table 1. Most respondents were abdominal or hepatobiliary surgeons (31.3%), followed by surgeons of other subspecialties (28.9%) and surgical trainees (23.8%). The majority of respondents worked in nonuniversity teaching hospitals (56.7%), followed by university hospitals (22.7%) and nonteaching hospitals (20.5%). This closely resembles the general distribution in the Netherlands [14]. The total number of estimated cholecystectomies in the last 12 months was 14,387.
Table 1
Clinical profile of the respondents
N
| |
|---|---|
Differentiation | |
Surgeon, abdominal or hepatobiliary | 142 (31.3%) |
Surgeon, other subspecialty | 131 (28.9%) |
General surgeon/fellow | 49 (15.9%) |
Surgical trainee | 108 (23.8%) |
Type of hospital | |
University hospital | 103 (22.7%) |
Teaching hospital | 257 (56.7%) |
Nonteaching hospital | 91 (20.5%) |
No. of cholecystectomies in past 12 months | |
<10 | 60 (13.2%) |
10–25 | 117 (25.8%) |
26–50 | 194 (42.8%) |
>50 | 82 (18.1%) |
Operative technique
The CVS technique was used by 97.6% of the respondents. It was documented by 91.6%, usually in the operation notes. Photographs of the CVS were stored by 42.7% of surgeons and video images by 30.1%. If the CVS cannot be obtained, 50.9% opt for conversion to open surgery, 39.1% continue laparoscopically, and 10.0% perform additional imaging studies.
Intraoperative imaging studies
More than half of the surgeons (53.2%) never perform IOC. The remainder use it incidentally (<5%). Only 2.6% of the surgeons perform IOC routinely (>80% of cholecystectomies). Indications for IOC according to the surgeons were suspected BDI (53.0%), unclear anatomy (46.6%), and suspected common bile duct (CBD) stones (38.0%). Laparoscopic ultrasound was used by 2.1% of the surgeons.
Bile duct injuries
Of the respondents, 20.3% had experienced one or more cases of BDI in the past 12 months. These injuries involved the cystic and Luschkan ducts (type A injuries according to the Amsterdam criteria [15]) in 77.2% of cases and the CBD (nine cases of type B and ten type D) in 18.1% (Table 2). The self-reported BDI rate was 105/14,387 = 0.73%. The self-reported rate of major BDI (i.e., involving the CBD) was 19/14,387 = 0.13%.
Table 2
Operative technique and imaging
N
| |
|---|---|
CVS technique used | |
Yes | 442 (97.6%) |
No | 11 (2.4%) |
CVS documented | |
Yes | 405 (91.6%) |
No | 37 (8.4%) |
N/A | 11 |
CVS documented bya
| |
Operation notes | 324 (80.0%) |
Photograph | 173 (42.7%) |
Video | 122 (30.1%) |
N/A | 48 |
What course when CVS is not obtained | |
Usually continue laparoscopically | 165 (39.1%) |
Usually convert to open | 225 (50.9%) |
Usually additional imaging studies | 44 (10.0%) |
N/A | 11 |
IOC performed | |
Never | 241 (53.2%) |
<5% | 187 (41.3%) |
5–20% | 8 (1.8%) |
21–80% | 5 (1.1%) |
>80% | 12 (2.6%) |
Indications for IOCa
| |
Routine | 17 (3.8%) |
Suspected CBD stones | 172 (38.0%) |
Unclear anatomy | 211 (46.6%) |
Suspected BDI | 240 (53.0%) |
Other | 54 (11.9%) |
Laparoscopic ultrasound performed | |
Never | 443 (97.8%) |
<5% | 7 (1.5%) |
5–20% | 2 (0.4%) |
21–80% | 0 |
>80% | 1 (0.2%) |
BDI in the past 12 months | |
None | 361 (79.7%) |
1 | 79 (17.4%) |
2 | 13 (2.9%) |
>2 | 0 |
Types of BDI | |
Cystic stump leak | 53 |
Luschkan duct leak | 28 |
CBD leak | 9 |
CBD transsection | 10 |
Other | 5 |
The rate of self-reported major BDI was not correlated with the level of training of the surgeon, the course of action if CVS could not be obtained, or the use of IOC (Table 3). There was a nonsignicantly lower rate of major BDI in university hospitals (P = 0.098) and a higher rate in the group of surgeons who perform fewer than 10 cholecystectomies per year (P = 0.082). These figures are based upon self-reporting and were not corrected for the indication for performing the cholecystectomy, i.e., cholecystitis or biliary colic.
Table 3
Factors associated with major BDI (i.e., involving the CBD)
No. of surgeons | Accumulated No. of cholecystectomiesa
| Major BDIb
|
P
| |
|---|---|---|---|---|
Differentiation | 0.621 | |||
Abdominal/HPB surgeon | 142 | 5267 | 6 (0.11%) | |
Other subspecialty | 131 | 3786 | 7 (0.18%) | |
General surgeon / fellow | 49 | 2580 | 4 (0.16%) | |
Surgical trainee | 108 | 2754 | 2 (0.07%) | |
Type of hospital | 0.098 | |||
University teaching | 103 | 2005 | 0 | |
Nonuniversity teaching | 257 | 8679 | 11 (0.13%) | |
Nonteaching | 91 | 3703 | 8 (0.22%) | |
No. of cholecystectomies in past 12 months | 0.082 | |||
<10 | 60 | 300 | 2 (0.67%) | |
10–25 | 117 | 1989 | 2 (0.10%) | |
26–50 | 194 | 7178 | 9 (0.13%) | |
>50 | 82 | 4920 | 6 (0.12%) | |
What course when CVS is not obtained
c
| 0.350 | |||
Usually continue laparoscopically | 165 | 5139 | 8 (0.16%) | |
Usually convert to open | 225 | 7291 | 11 (0.15%) | |
Usually additional imaging | 44 | 1369 | 0 | |
IOC performed | 0.505 | |||
Never | 241 | 7495 | 12 (0.16%) | |
<5% | 187 | 6342 | 6 (0.09%) | |
5–20% | 8 | 218 | 1 (0.46%) | |
21–80% | 5 | 136 | 0 | |
>80% | 12 | 196 | 0 |
Opinions on IOC
IOC was regarded as cumbersome by 39.0% of the surgeons (Table 4). Most surgeons (77.5%) assume IOC will take 10–30 min. Around one third of the surgeons think IOC reduces the risk of major BDI, one third does not, and one third does not know. A large majority (92.9%) of the surgeons feel that IOC should not be performed routinely.
Table 4
Opinions on IOC
N
| |
|---|---|
Performing IOC is cumbersome | |
Usually | 74 (16.3%) |
More often than not | 103 (22.7%) |
Sometimes | 127 (28.0%) |
Usually not | 114 (25.2%) |
Missing | 35 (7.7%) |
How long does IOC take | |
<10 min | 30 (6.7%) |
10–20 min | 179 (39.5%) |
20–30 min | 170 (37.5%) |
30–40 min | 50 (11.0%) |
>40 min | 24 (5.3%) |
IOC reduces the risk of major BDI | |
Yes | 134 (29.6%) |
No | 153 (33.8%) |
Don’t know | 136 (36.6%) |
IOC should be performed routinely | |
Not | 421 (92.9%) |
In all teaching hospitals | 21 (4.6%) |
In all hospitals | 11 (2.4%) |
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Trainees
All trainees reported use of the CVS technique versus 96.8% of other surgeons (P = 0.074). There were more trainees who never performed IOC than other surgeons (72.2% vs. 47.2%, P = 0.002 in linear-by-linear association).
Discussion
The current study is an inventory of safety measures during cholecystectomy in a broad population of general surgeons and trainees in the Netherlands. The response rate was fair with 40.4%, allowing a comparison with a similar survey in the United States [16] and a survey among British and Irish upper-GI surgeons [17]. The distribution of the respondents with regard to type of hospital resembled the general distribution in the Netherlands. The self-reported number of cholecystectomies performed yearly represents about 60% of the 24,000 performed yearly [18]. The survey therefore provides a reliable representation of the general Dutch practice.
The critical view of safety (CVS) was found to be widely accepted in Dutch practice: 97.6% of the respondents use this technique. Reviewing 13 Dutch cholecystectomy protocols in 2008, Wauben et al. [19] found that only one explicitly incorporated the use of CVS. It seems that although protocols need to be updated in some hospitals, the CVS is widely accepted in the Netherlands as the gold standard. The implementation of the most important safety measure to prevent bile duct injury (BDI) can thus be considered highly successful and is praiseworthy. In a similar survey by Sanjay et al. [17], 82% of the British and Irish upper-GI surgeons advocated the CVS technique. It is unknown how often this technique is actually practiced by British general surgeons or how well institutionalized the CVS technique is in other countries.
Documentation of the CVS in the operation notes is done by 80.0% of surgeons, and augmented by a majority by video or photographs. The course of action when CVS is not obtained varies. Although the nature of the question does not address some of the nuances in difficult cholecystectomies, a divergent strategic approach of the surgeons is illustrated. Timely conversion in case of uncertain anatomy is seen by many surgeons as an important safety measure. However, as the open approach is increasingly reserved for “difficult cases” and experience with the open technique diminishes, there are increasing reports of BDI occurring after conversion [20, 21]. Depending on the experience of the surgeon, other alternatives such as laparoscopic subtotal cholecystectomy may in some cases be safer than conversion. In a Dutch series of 1509 patients, experienced laparoscopy surgeons were four times less likely to convert than less experienced laparoscopy surgeons (3.6% vs. 15.6%) [22]. The conversion rate in the Netherlands varies; up to 18% has been reported [23]. These papers, like most, do not assess whether CVS was achieved.
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Intraoperative cholangiography (IOC) is very seldom performed in the Netherlands; 53.1% of surgeons never use it and 41.3% perform it incidentally (<5% of cholecystectomies). This contrasts with the practice in the US and the UK, where over 25% of surgeons routinely perform IOC and there are few surgeons who never apply it [16, 17]. In Australia, IOC is performed in over 60% of cholecystectomies [12]. Despite the fact that many Dutch surgeons feel that suspected common bile duct (CBD) stones, unclear anatomy, and suspected bile duct injury (BDI) are indications for IOC, in clinical practice they only rarely apply it.
Approximately one third of the responding surgeons believed that IOC reduces the risk of BDI, one third did not, and one third indicated that they did not know. Opinions were divided on whether IOC was a cumbersome procedure and how much time it consumes. The great majority of surgeons (93%) believe that IOC should not be routinely practiced. This is remarkable as many of these surgeons believed that IOC reduces the risk of BDI. Apparently, the arguments against routine IOC are thought to outweigh the benefits. Additionally, Dutch insurance companies currently do not reimburse the surgeon for performing IOC. The guidelines currently do not advise selective or routine IOC, and this is reflected in the daily practice of Dutch surgeons. Although the discussion on whether to perform IOC routinely or selectively is far from closed, it seems undesirable that surgeons would lose the skill of IOC altogether. We advocate a low threshold for IOC, especially in complicated biliary disease such as cholangitis and pancreatitis, and certainly in cases of unclear anatomy. An attitude change may be necessary in order for Dutch surgeons to apply IOC more frequently as an investment in patient safety.
The self-reported major BDI rate (i.e., involving the CBD) was 0.13%. This is much lower than the figures mentioned in the literature and similar to the rate observed before the laparoscopic era [11, 24]. Caution is necessary interpreting this figure as a survey such as this is not the optimal tool to assess the occurrence of complications. No evidence could be found in the literature on the validity of self-reported complications by surgeons. Further research is needed to confirm this low complication rate. The most important limitation of this study is that it relies on self-reporting. It cannot be confirmed that the surgeons use the techniques that they report to use and to what extent. However, the results are certainly of interest as they reflect opinions on and the acceptance of safety measures during cholecystectomy.
In summary, our survey provides insight into safety precautions taken by Dutch surgeons to prevent BDI during cholecystectomy. The CVS approach is embraced by virtually all Dutch surgeons. When CVS is not obtained, different approaches are used, with half of the surgeons choosing to convert. IOC seems to be an endangered skill as over half the Dutch surgeons never perform it and the rest do so only incidentally. Although one may argue as to whether IOC should be performed routinely or selectively, it seems an undesirable development that surgeons would lose the skill of IOC altogether.
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Acknowledgments
We thank all the Dutch surgeons who took the time to participate in this survey. We are also indebted to Dr. J. Niesing for his help with the development of the questionnaire.
Conflict of interest
The authors have no conflicts of interest or financial ties to disclose.
Open Access
This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
Open AccessThis is an open access article distributed under the terms of the Creative Commons Attribution Noncommercial License (https://creativecommons.org/licenses/by-nc/2.0), which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.