Preoperative patient-related risk factors for conversion of laparoscopic cholecystectomy to open surgery.
Abstract
Background: Laparoscopic cholecystectomy is the preferred surgical operation for symptomatic gallstone disease. Conversion of laparoscopic cholecystectomy to open surgery is used to prevent intra-abdominal organ injury, for open common bile duct exploration and to repair intra-abdominal organ injury.
Keywords
- laparoscopic cholecystectomy
- conversion to open surgery
- risk factors
- predictive models
- intra-abdominal organ injury
- surgical quality indicators
1. Introduction
The prevalence of cholelithiasis in an adult Western population is between 15 and 20% [1, 2]. In the United States, an estimated 11.8 million people aged between 20 and 74 years have gallbladder (GB) stones [3]. Yearly approximately 1–2% of patients with silent gallstones develop symptoms and require treatment (Figure 1) [4–6]. Acute cholecystitis (AC) accounts for 20% of patients presented to hospital with right upper quadrant pain, which in patients with significant co-morbidities and in the elderly is associated with 2–3% mortality [5, 7, 8]. In the United States, in 2009, cholecystitis was the underlying cause of death in 2009 patients and a contributing cause of death in 3295 patients accounting for a mortality crude rate of 0.7 per 100,000 patients [9]. In the same country, GB disease is one of the most common inpatient diagnosis that accounts for more than 260,000 hospital admissions and annual health care provider expenditure exceeding $3.03 billion [9].
Laparoscopic cholecystectomy (LC) is considered as the “gold standard” surgical technique for treatment of GB disease [10]. Conversion of LC to open surgery (CTO) is used to prevent intra-abdominal organ injury (IOI), for common bile duct (CBD) exploration and to repair IOI.
The aim of this chapter is to review risk factors and predictive models for CTO, and surgical quality outcome measures.
2. Laparoscopic cholecystectomy
LC is the minimally invasive surgical operation that was introduced in clinical practice by Erich Muehe of Boeblingen, Germany, in 1985 [11]. LC can be performed with the conventional four-port or three-port technique.
Compared to the conventional open cholecystectomy (OC), LC has decreased post-operative pain, decreased respiratory function dysfunction, reduced post-operative ileus, earlier oral fluid and food intake, better cosmesis, reduced patient’s hospital stay, fastened post-operative recovery and lowered morbidity and mortality [12–14].
A meta-analysis comparing LC with the small-incision OC (the length of incision of less than 8 cm) demonstrated that both techniques had similar rates of mortality; intraoperative, minor and severe post-operative complications (without bile duct injuries, BDI); BDI; total complications; and post-operative convalescence [15]. A subgroup analysis of high-quality trials showed a shorter operative time for the small-incision OC than LC (weighted mean difference, random effects 16.4 min, 95% CI: 8.9–23.8 min) [15]. Compared with the small-incision OC, the self-reported quality of life up to 30 days after LC is higher; 2326 (95% CI: 2187–2391) and 2411 (95% CI: 2334–2502), respectively,
Main disadvantages of LC compared to the conventional OC and small-incision OC are a lack of a three-dimensional view, narrow field of laparoscopic vision, inconvenience with liver retraction, insufficient tactile sensations due to manipulation with long laparoscopic instruments and difficulties with instruments placement and manoeuvring [17–19].
Another significant limitation of LC is an increased risk of IOI, including bile duct injury (BDI) [20, 21]. In the United States, approximately 750,000 LCs are performed annually [22]. With the incidence of major BDI during LC fluctuating between 0.4 and 2%, it is expected that 3000 to 15,000 patients will suffer from iatrogenic BDI [21, 23, 24]. Major BDI is associated with significant morbidity, mortality and socioeconomic burden [21].
2.1. Indications for conversion of LC to open surgery
The primary indication for CTO is to prevent IOI. CTO can also be used for CBD exploration, to repair cholecysto-intestinal fistula and to perform an extended OC in patients with gallbladder cancer. In addition, CTO is performed to control haemorrhage and repair single or multiple IOI [25, 26].
Compared to LC, CTO is associated with an increased morbidity and mortality. A clinical audit of 7242 LCs for AC performed in the United States between 2005 and 2011 showed that compared to the LC group, patients who underwent CTO had higher rates of surgical site infection (1.8 versus 9.2%,
2.2. Risk factors for conversion of LC to open surgery
As high rate of CTO and IOI can diminish clinical benefits and cost-effectiveness of LC, identification of preoperative and intraoperative patient-dependent and surgeon-related risk factors for CTO can be used for development of risk stratification models and refinement of the management. This will keep CTO at low rates and maintain benefits of minimally invasive GB surgery.
2.2.1. Preoperative patient-related risk factors
Preoperative patient-related risk factors for CTO have been extensively investigated and identified. In previous studies, the advanced age has been shown to be a risk factor for CTO [25, 27, 28]. In a meta-analysis, Yang et al. demonstrated that age >65 years is associated with a twofold increase in CTO rate (odds ratio (OR) = 1.8; 95% confidence interval (CI): 1.4–2.5;
Preoperative patient-related risk factors for CTO | OR | 95 CI | References | |
---|---|---|---|---|
Advanced age (>65 years) | 1.8 | 1.4–2.5 | <0.0001 | [29] |
Male | 2.8 | 1.1–6.6 | 0.037 | [32] |
Clinical diagnosis of AC | 8 | 6.1–10.5 | <0.00005 | [35] |
Duration of AC >72 h | 3.1 | 1.2–7.7 | 0.0072 | [37] |
Repeated attacks of AC, 2 | 7.9 | 1.5–76.8 | <0.0052 | [41] |
Diabetes mellitus | 2.5 | 1.3–4.4 | 0.003 | [43] |
Obesity, BMI >30 kg/m2 | 7.6 | 4.1–14 | <0.001 | [52] |
Previous upper abdominal surgery | 20.4 | 2.4–927.4 | 0.0007 | [50] |
Post-ERC/ES, 16 weeks | 3 | 1.2–7.4 | 0.009 | [57] |
WCC 11 109/L | 4 | 2.5–6.1 | <0.00005 | [25] |
Elevated CRP, 10 mg/L | 1.05 | 1.01–1.09 | 0.014 | [37] |
Elevated total bilirubin | 6.5 | 4.1–10.2 | <0.00005 | [64] |
Alkaline phosphatase (>135 U/L) | 7 | 3.6–14 | <0.00001 | [52] |
Gallbladder wall thickness, mm | 2 | 1.7–2.3 | <0.00005 | [52] |
Pericholecystic fluid on US | 26 | 5.0–166.1 | <0.00005 | [41] |
ASA score >2 | 2.5 | 1.3–4.6 | 0.004 | [66] |
A. Local signs of inflammation, etc.: |
(1) Murphy’s sign, (2) RUQ mass/pain/tenderness |
B. Systemic signs of inflammation, etc.: |
(1) Fever, (2) raised WCC, (3) elevated CRP |
C. Imaging findings: imaging findings characteristic of acute cholecystitis |
(1) Trans-abdominal ultrasound findings: |
Positive sonographic Murphy sign (ultrasound transducer elicited tenderness on gentle pressure over the gallbladder |
Thickened gallbladder wall (>4 mm, provided there is no congestive heart failure, chronic liver disease and ascites) |
Marked distension of the gallbladder (long axis diameter >80 mm, short axis diameter >40 mm) |
Gallstone impacted in Hartman’s pouch; biliary sludge, pericholecystic fluid collection |
Sonolucent halo in the gallbladder wall |
(2) CT findings: |
Gallbladder distension |
Gallbladder subserosal oedema |
Gallbladder wall thickening |
Pericholecystic stranding, fluid collection |
(3) Magnetic resonance imaging findings: |
Cystic duct stone |
Intraluminal sludge |
Pericholecystic high signal |
Gallbladder distension |
Gallbladder wall thickening, abnormal signal intensity and oedematous stratification |
(4) Tc-HIDA scan findings: |
Non-visualized gallbladder within 1 h |
“Rim sign” (increased pericholecystic hepatic radioactivity) |
Suspected diagnosis: One item in A + one item in B |
Definite diagnosis: One item in A + one item in B + C |
Male gender is a well-recognized risk factor for difficult LC and CTO [18, 25, 28, 29]. Males have more prominent adhesions between the GB and the omentum and surrounding internal organs, have a higher proportion of severe forms of AC on histological examination of the GB, have a higher CTO rate and require a longer operation time [31]. Two-stage LC male patients have a three times higher rate of CTO (OR = 2.8; 95% CI: 1.1–6.6,
Patients with the clinical diagnosis of AC and higher severity grades of AC carry more chances of CTO [25, 33, 34]. Diagnostic criteria for AC are presented in Table 2 [34]. AC patients have eight times higher risk of CTO than patients with uncomplicated gallstone disease (OR = 8.01; 95% CI: 6.1–10.5;
Grade I (mild) acute cholecystitis |
Does not meet the criteria of “grade III” or “grade II” acute cholecystitis. Grade I can also be defined as acute cholecystitis in a healthy patient with no organ dysfunction and mild inflammatory changes in the gallbladder, making cholecystectomy a safe and low-risk operative procedure |
Moderate (grade II) acute cholecystitis |
Grade II (moderate) acute cholecystitis |
Associated with any one of the following conditions: |
1. Elevated white cell count (>18,000/mm3) |
2. Palpable tender mass in the right upper quadrant |
3. Duration of complaints > 72 h |
4. Marked local inflammation (gangrenous cholecystitis, pericholecystic abscess, hepatic abscess, biliary peritonitis, emphysematous cholecystitis) |
Grade III (severe) acute cholecystitis |
Associated with dysfunction of any one of the following organs/systems: |
1. Cardiovascular dysfunction (hypotension requiring treatment with dopamine ≥5 mcg/kg/min, or any dose of norepinephrine) |
2. Neurological dysfunction (decreased level of consciousness) |
3. Respiratory dysfunction (PaO2/FiO2 ratio <300) |
4. Renal dysfunction (oliguria, creatinine >2.0 mg/dL) |
5. Hepatic dysfunction (PT-INR >1.5) |
6. Haematological dysfunction (platelet count <100,000/mm3) |
The longer the duration of untreated AC, the greater is the risk for CTO [27]. Asai et al. showed that 12 of 29 (41.4%) patients in the CTO group and 36 of 196 (18.4%) patients in LC group had symptoms of AC for longer than 72 h (
Repeated attacks of AC are associated with difficult LC and CTO [38–40]. When compared to AC patients with less than two previous episodes, patients with at least two past attacks of AC have an eightfold increase in the difficulty of LC (OR = 7.9; 95% CI: 3.4–18.2;
Diabetes mellitus (DM) has been consistently shown to be associated with CTO [18, 25, 42]. Diabetics undergoing LC have a 2.5 times higher risk for CTO than nondiabetic patients (OR = 2.5; 95% CI: 1.3–4.4,
Obesity (body mass index (BMI) > 30 kg/m2) is not only a risk factor for CTO but also associated with major BDI [18, 28, 50, 51]. Obese patients undergoing LC have an eightfold higher risk of CTO than non-obese patients (OR = 7.6; 95% CI: 4.1–14;
Previous surgery above the umbilicus is a risk factor for CTO [52, 54]. In Lee’s study, 7 (17%) of 41 patients from the CTO group and 1 (1%) of 100 patients from the LC group had a history of previous upper abdominal surgery [50]. This estimates the risk for CTO for patients with the past history of upper abdominal surgery 20 times higher than for those without previous surgery above the umbilicus (OR = 20.4, 95% CI: 2.4–927.4;
The risk of CTO is also higher in patients following endoscopic retrograde cholangiography with sphincterotomy (ERC/ES) for CBD stone clearance [54–56]. A two-stage LC after 15 weeks following ERC/ES increases the rate of CTO three times (RR = 2.7, 95% CI: 1.4–5.5,
Thickened gallbladder wall on ultrasound (US) of the upper abdomen is associated with CTO [25, 28]. The risk of CTO doubles with every millimetre increase in gallbladder wall thickness (OR = 2; 95% CI: 1.7–2.3;
The presence of pericholecystic fluid on imaging of the abdomen increases the risk of CTO by 26 times (OR = 26; 95% CI: 5.0–166.1;
An elevated white cell count (WCC) is a predictor of CTO [28]. Compared to the LC group, the CTO group had a higher proportion of patients with leucocytosis, defined as WCC ≥ 11 × 109/L, 161 (12.7%) of 1265 patients versus 41 (36.6%) of 112 patients, respectively,
Histopathology of acute cholecystitis |
WCC cut-off (95 CI) |
CRP cut-off (95 CI) |
AUC of WCC (95 CI) |
AUC of CRP (95 CI) |
|
---|---|---|---|---|---|
Overall AC | 9.15 (8.7–9.6) | 30.5 (10.2–50.8) | 0.83 (0.79–0.87) | 0.94 (0.92–0.97) | <0.00005 |
Mild AC | 9.01 (8.7–9.32) | 26.5 (13.6–39.4) | 0.79 (0.74–0.84) | 0.93 (0.9–0.95) | <0.00005 |
Moderate-severe AC | 11.05 (10.22–11.88) | 67 (61.9–72.1) | 0.92 (0.88–0.97) | 0.99 (0.97–1.0) | 0.0093 |
Acute on chronic cholecystitis | 9.15 (8.81–9.49) | 26.5 (15.72–37.28) | 0.72 (0.65–0.79) | 0.87 (0.82–0.92) | 0.0004 |
Acute edematous cholecystitis | 9.05 (8.29–9.81) | 30.5 (3.34–51.68) | 0.78 (0.69–0.87) | 0.93 (0.87–0.99) | 0.0001 |
Acute necrotizing cholecystitis | 9.05 (6.97–11.12) | 57.5 (34.74–80.26) | 0.89 (0.83–0.95) | 0.97 (0.94–1.0) | 0.0149 |
Acute suppurative cholecystitis | 9.15 (7.96–10.34) | 92 (76.43–111.57) | 0.82 (0.67–0.97) | 1.0 (1.0–1.0) | 0.0189 |
Acute gangrenous cholecystitis | 11.65 (10.63–12.67) | 67 (61.78–72.22) | 0.93 (0.89–0.98) | 0.99 (0.97–1.0) | 0.0375 |
Pericholecystic abscess/ gallbladder perforation |
9.15 (7.82–10.48) | 86 (66.28–105.72) | 0.89 (0.76–1.0) | 1.0 (1.0–1.0) | 0.0852 |
An elevated C-reactive protein (CRP) level also predicts CTO [62]. Every 10 mg/L increase in CRP concentration, the rate of CTO increases by 5% (OR = 1.05; 95% CI: 1.01–1.09;
Deranged liver function tests predict CTO [28, 64]. Patients with elevated concentrations of total bilirubin and alkaline phosphatase (>135 U/L) have seven times higher risk of CTO, OR = 6.5 (95% CI: 4.1–10.2;
An increasing ASA score has been shown in multiple studies to be an independent risk factor for CTO [25, 27, 28, 52, 62, 66]. Patients with ASA score of 3 have 2.5 times odds of CTO (OR = 2.5; 95% CI: 1.3–4.6) than those with ASA score of 1 (
2.2.2. Intraoperative patient-related risk factors
To prevent IOI during LC, when the surgeon encounters dense intra-abdominal adhesions, extensive inflammatory changes around the gallbladder, haemorrhage, inability to grasp and retract a friable gallbladder with forceps, CTO is advised [67].
Severe intra-abdominal adhesions make laparoscopic dissection very difficult and are associated with a fivefold increase in CTO risk (OR = 5.2; 95% CI: 1.9–14.4;
Intense inflammatory infiltrate in the Calot’s triangle makes identification of the cystic duct and cystic artery very challenging predisposing patients to iatrogenic BDI and uncontrollable bleeding [32, 35]. To prevent BDI, CTO is directed when one of three fundamentals of the critical view of safety cannot be ascertained [30, 68]. These essentials include the clearance of the Calot’s triangle from adipose and fibrous tissue, detachment of the lowest part of the gallbladder from the GB bed and identification of the cystic duct and cystic artery going into the gallbladder (Figure 2) [69]. Alternatively, when the surgeon encounters severe inflammatory or desmoplastic reaction in the Calot’s triangle laparoscopic subtotal cholecystectomy can be performed [70–72].
Unclear biliary anatomy is another reason for CTO [20]. Instead, intraoperative cholangiography (IOC) can be used to prevent misidentification of the cystic duct and prevent BDI [73, 74]. Failure of the contrast to opacify the common hepatic duct and the right and left hepatic ducts would signal the surgeon that the CBD, not the cystic duct, has been cannulated [74]. The use of IOC is associated with a 62% reduction in CTO rate (OR = 0.38, 95% CI: 0.17–0.94;
Intraoperative patient-related risk factors for CTO |
Adhesions caused by previous upper abdominal operations |
Adhesions in the upper abdomen caused by severe pericholecystic tissue inflammation |
Enlarged fatty liver (steatohepatitis) restricting access and inability to elevate gallbladder to dissect Calot’s triangle |
Intra-hepatic gallbladder |
Necrotic gallbladder wall |
Thickened sclerotic gallbladder wall/porcelain gallbladder |
Gallbladder perforation with biliary peritonitis |
Large gallbladder stone impacted in Hartman’s pouch/Mirizzi syndrome |
Fibrosis of tissue in Calot’s triangle |
Severe inflammation in Calot’s triangle |
Uncontrollable bleeding from cystic artery, hepatic artery, gallbladder bed |
Cholecysto-intestinal fistula |
Unclear biliary anatomy |
Choledocholithiasis requiring open CBD exploration |
Suspicion of gallbladder cancer |
Intra-abdominal organs injury |
Intolerance of intraperitoneal carbon dioxide insufflation |
CTO is performed when open CBD exploration and stone clearance is required provided CBD stones cannot be removed laparoscopically or post-operatively by ERC/ES [20, 76, 77]. Furthermore, CTO is advised for an open repair of intraoperatively diagnosed IOI [20, 25]. Infrequently, CTO is necessary when the patient is not able to tolerate 12 mm Hg intraperitoneal carbon dioxide insufflation pressure and develops premature ventricular beats and bradycardia with hypotension [20].
Intraoperative patient-related risk factors that may require conversion of laparoscopic cholecystectomy to open surgery are presented in Table 5.
2.2.3. Surgeon-related risk factors
Surgeon’s knowledge, laparoscopic fellowship training, operative experience and skills in laparoscopic surgery play an important role in timely recognition of the need for CTO and are important predictors for CTO [49, 74, 75, 78]. Surgical registrars (postgraduate year 4–5) have a twofold higher rate of CTO (OR = 1.7; 95% CI: 1.1–2.5;
Importantly, there is statistically significant inverse correlation between surgeons’ LC volume and the rate of CTO (
2.3. Predictive models for conversion of LC to open surgery
Few predictive models have been developed to help the surgeon make an early CTO decision. Lipman et al. found that variables such as male gender, WCC ≥ 11 × 109/L, low albumin, pericholecystic fluid on US, the presence of diabetes mellitus and elevated total bilirubin independently predict CTO. These risk factors were included into the model which has the AUC of 83%. The authors showed that if none of these risk factors were present, the risk of conversion is 2%, but when six risk factors were present, the risk of conversion escalated to 90% [25].
Kama et al. presented a CTO risk scoring model consisting of a constant (-20) and six variables with their coefficients, age ≥60 years (coefficient of 5), male gender (11), previous upper abdominal surgery (8), abdominal tenderness (9), thickness of gallbladder wall >4 mm on US (13) and the clinical diagnosis of AC (15) [83]. The final risk score for CTO (RSCLO) is the sum of the constant and coefficients of the risk factors that are present in an individual patient. The RSCLO can take a value between −20 and 41. An operation with RSCLO exceeding −3 is considered difficult [84].
Goonawardena et al. proposed a CTO prediction model that is constructed on five independent variables, previous upper abdominal surgery, obesity (BMI > 30 kg/m2) and the presence of choledocholithiasis, impacted stone at the Hartmann’s pouch and GB wall thickening on the trans-abdominal US [52].
Sugrue et al. developed an intraoperative 10-point scoring system for an assessment of the difficulty in LC [85]. A score of <2 indicates mild degree difficulty, 2–4 moderate, 5–7 severe and 8–10 the extreme difficulty of LC [85].
These predictive models have limitations. They have not been tested on an independent sample. Therefore, their real-life predictive ability is unknown. In addition, these models excluded surgeon-related risk factors. Thus, it is difficult to tailor management of high-risk for CTO patients according to an available hepato-biliary expertise.
3. Outcomes and quality indicators in laparoscopic cholecystectomy
Patient-reported outcome measures including generic (the Short Form 36 (SF-36) Health Survey, Nottingham Health Profile), preference-based (European Quality of Life Questionnaire, EQ-5D) and condition-specific instruments (Otago Gallstones Condition-Specific Questionnaire, Gastrointestinal Quality of Life Index, Abdominal Surgery Impact Scale and Gallstone Impact Checklist) as well as economic evaluations (cost–minimization analysis, cost–consequence analysis, cost–effectiveness analysis, cost–utility analysis and cost–benefit analysis) can also be used as outcome measures.
4. Conclusion
LC is the treatment of choice for symptomatic GB disease, which in some patients requires CTO. CTO risk stratification based on patient- and surgeon-dependent variables may allow a better patient’s management to keep CTO at low rates and maintain benefits of minimally invasive GB surgery. The absence of an association between CTO and IOI is an important surgical safety indicator that demonstrates that CTO is used as a safety strategy rather than an emergency measure to repair iatrogenic IOI and control haemorrhage.
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