Advantages of early cholecystectomy in clinical practice of a terciary care center

Madrid, Spain

Advantages of early cholecystectomy in clinical practice of a terciary care center

Marta Barceló, Dulce María Cruz-Santamaría, Cristina Alba-López, María José Devesa-Medina, Manuel Díaz-Rubio and Enrique Rey

Madrid, Spain

BACKGROUND:Despite a number of studies show the superiority of early over delayed cholecystectomy in the treatment of acute cholecystitis, there is still controversy over the time for intervention. This study aimed to assess the use of early versus delayed cholecystectomy for the treatment of acute cholecystitis in terms of complications, conversion to open surgery and mean hospital stay.

METHOD:We collected patients with acute cholecystitis treated at a referral center for a year, and retrospectively analyzed the chosen therapeutic approach, the percentage of conversion of early cholecystectomy to open surgery, appearance of surgical complications, and mean hospital stay.

RESULTS:The study included 117 patients, 44 women and 73 men, who had a mean age of 67.36±15.74 years. Early cholecystectomy was chosen in 31 (26.5%) and delayed cholecystectomy in 74 patients (63.2%). Of the 74 patients, 28 (37.8%) required emergency performance of delayed cholecystectomy, and 19 (25.7%) had not undergone surgery by the end of the study. While no differences were observed between early and delayed cholecystectomy in terms of surgical complications and conversion to open surgery, mean hospital stay was nevertheless signif i cantly shorter in the early versus the delayed cholecystectomy group (8.32±4.98 vs 15.96±8.89 days).

CONCLUSION:Under the routine working conditions of a hospital that is neither specially dedicated to the surgical treatment of acute cholecystitis nor provided with specif i c management guidelines, early cholecystectomy can reduce the hospital stay without increase of the conversion rate or complications.

(Hepatobiliary Pancreat Dis Int 2013;12:87-93)

acute cholecystitis; cholecystectomy; complications

Introduction

Gallstones (cholelithiasis) has a prevalence of around 10% and an annual incidence of 0.5%.[1,2]Approximately, 35% of patients with cholelithiasis develop complications or recurrent symptoms in their lifetime,[3]indicating that every year, 1% to 2% of patients with asymptomatic cholelithiasis develop biliary colic and 0.5% present with some complications.[4-6]The most frequent complication is acute cholecystitis, accounting for 15%-26% of all complications in patients with symptomatic cholelithiasis.[7,8]

Although 75% of patients with acute cholecystitis respond to medical treatment in the fi rst 24-48 hours, the only def i nitive treatment is cholecystectomy. Comparative studies clearly show that early cholecystectomy affords outcomes similar to those of delayed cholecystectomy, albeit with a shorter mean stay,[9-28]thus making it more cost-effective.[9,17]

Despite such scientif i c evidence, only 12% to 30% of cholecystectomies for acute cholecystitis are performed early in the USA,[29-31]20% in the United Kingdom[32]and 46% in Japan.[33]Moreover, surgeons continue to express a preference for delayed cholecystectomy.[34]

There is no clear reason for this divergence between the evidence on the one hand and standard clinical practice on the other. It is possible that the conditions under which randomised prospective clinical studies are conducted are not representative of routine working conditions. A recent study[35]reported that these benef i ts were applicable to standard practice, and yet the results of this study might not be truly representative, in that the standard practice in question had been previously stimulated by a randomised study and specif i c trainingprogramme undertaken at the hospital. There is no clear information about the benef i ts of early cholecystectomy performed at a general hospital with neither any special dedication nor specif i c training for the treatment of acute cholecystitis.

Accordingly, our study assessed the use of early versus delayed cholecystectomy for the treatment of acute cholecystitis in terms of complications, percentage of conversion to open surgery, and mean hospital stay.

Methods

A retrospective observational study was undertaken in patients with acute cholecystitis who had been admitted to Madrid's San Carlos Clinical Hospital between January 1, 2008 and January 1, 2009.

The hospital keeps a computerised record of discharge reports issued for all patients admitted. All the reports are processed by a coding unit, with the fi nal diagnoses coded in accordance with the off i cial Spanish translation of the International Classif i cation of Diseases, Ninth Revision, Clinical Modif i cation.

Patients

Using the record, we identif i ed all patients with diagnoses coded 575.0 (acute cholecystitis), 575.10 (cholecystitis unspecif i ed), 575.11 (chronic cholecystitis) and 575.12 (acute and chronic cholecystitis). The clinical histories of all patients identif i ed were reviewed to conf i rm the diagnosis of cholecystitis. Acute cholecystitis was def i ned as presence of compatible clinical (abdominal pain in the right hypochondrium with fever and positive Murphy sign), analytical (leukocytosis and elevation of acute-phase reactants) and echographic criteria (>4 mm thickening of the gallbladder wall, selective pain to pressure on the gallbladder, gallbladder dilatation or presence of pericholecystic fl uid in the absence of ascites).

Data collection

The clinical histories were reviewed, and the pre-def i ned data were collected: demographic data; characteristics of the acute cholecystitis episode (date of symptom onset, date of hospital admission, type of cholecystitis-lithiasic or alithiasic and presence of echographic signs of complicated cholecystitis at date of admission-emphysematous, gangrenous, and bladder perforation); patient characteristics that might inf l uence the therapeutic approach (existence of related disease or cardiovascular comorbidity, the American Society of Anesthesiologists (ASA) risk and existence of other additional diagnoses at date of admission); and the therapeutic decision adopted within the fi rst 48 hours of admission.

Patients were deemed to have related comorbidity in any case where there were cardiovascular risk factors or related diseases that might directly inf l uence surgical outcome, by increasing anesthetic or surgical risk or exerting a negative inf l uence on post-operative disease course. To this end, we used the classif i cation system designed by ASA to assess risk to patient status posed by anaesthesia. Comorbidity was def i ned as being present in any case where ASA risk was III or higher.

Data were obtained on patients' clinical progress, and in surgical treatment they included date of surgery; type of surgical approach (laparoscopic, open or laparoscopic converted to open surgery); appearance of pre-surgical, surgical or post-surgical complications; mean total stay; and mean pre- and post-surgical stay.

Def i nitions

We divided the severity of acute cholecystitis into three categories according to Tokyo Guidelines: (a) Mild (grade I) acute cholecystitis: “mild” acute cholecystitis. can be def i ned as acute cholecystitis in a healthy patient with no organ dysfunction and only mild inf l ammatory changes in the gallbladder, making cholecystectomy a safe and low-risk operative procedure; (b) Moderate (grade II) acute cholecystitis: "moderate" acute cholecystitis is accompanied by one of the following conditions: 1. elevated WBC count (>18 000/mm3), 2. palpable tender mass in the right upper abdominal quadrant, 3. duration of complaints >72 hours, 4. marked local inf l ammation (biliary peritonitis, pericholecystic abscess, hepatic abscess, gangrenous cholecystitis, emphysematous cholecystitis); (c) Severe (grade III) acute cholecystitis: "severe" acute cholecystitis is accompanied by dysfunctions in one of the following organs/systems: cardiovascular dysfunction (hypotension requiring treatment with dopamine 5 μg/kg per minute, or any dose of dobutamine); neurological dysfunction (decreased level of consciousness); respiratory dysfunction (PaO2/FiO2ratio <300); renal dysfunction (oliguria, creatinine >2.0 mg/dL); hepatic dysfunction (PT-INR >1.5); and hematological dysfunction (platelet count <100 000/mm3).

According to the approach adopted at the date of admission and surgical assessment, the following two possible attitudes to therapy were considered: early cholecystectomy (cholecystectomy within the fi rst 48 hours) and delayed cholecystectomy (medical treatment, followed by cholecystectomy after an acute episode). In the latter, three possible results were envisaged: (b1) emergency performance of delayedcholecystectomy, def i ned as a need for urgent surgery owing to poor response to medical treatment or to a new episode of acute cholecystitis while waiting for elective cholecystectomy; (b2) delayed cholecystectomy that was completed, def i ned as a favourable progress with medical treatment, followed by effective performance of elective cholecystectomy at the appointed time; and (b3) delayed cholecystectomy that was not completed, def i ned as a progress with medical treatment but no ensuing performance of elective cholecystectomy within the follow-up period.

Failure of medical treatment existed when treatment with a nothing per orem diet and antibiotherapy failed to lead to an appropriate clinical response, def i ned as an improvement in clinical manifestations, abdominal examination and analytical parameters which would allow for the reintroduction of oral diet. Reappearance of the clinical prof i le or a new episode of acute cholecystitis was def i ned as the case that the reappearance after the initial episode had been resolved.

"Pre-surgical complication" was def i ned as the appearance of gangrenous emphysematous cholecystitis, presence of empyema of the gallbladder or existence of bladder perforation whether they appeared in the form of abscess of the gallbladder wall or in the form of peritonitis (Grade II-III Tokio Criteria to severity cholecistitis). "Surgical or post-surgical complication" was considered as intra-operative bladder rupture, hemorrhage, bile-duct injury, wound infections or existence of bilioenteric fi stulae.

Similarly, "total hospital stay" was def i ned as the total number of days of hospitalization required by any patient (at one or more admissions) from date of emergency-ward admission to fi nal discharge after cholecystectomy. "Pre-surgical stay" was def i ned as time of hospitalisation, calculated from date of admission to intervention (at one or more admissions), and "postsurgical stay" as the number of days from date of surgery to hospital discharge.

"Problem resolution time" was def i ned as the total number of days elapsed, regardless of hospitalisation, between diagnosis of cholecystitis and discharge following cholecystectomy.

Post-cholecystectomy follow-up

Clinical histories were examined for evidence of development of biliary problems or late surgical complications until September 2009, so all patients had at least six months of follow-up.

Statistical analysis

All data were analyzed using the SPSS version 15.0. For the study of quantitative variables, numerical values were expressed as mean±standard deviation (SD). The Chi-square test was used for comparison of groups. Statistical signif i cance was set atP≤0.05.

Results

Patients

After a review of the clinical histories of 152 patients admitted in 2008 and allocated one of the designated codes, 35 were excluded because of failure to meet the acute cholecystitis def i nition criteria. Hence the study involved 117 patients, 44 women (37.6%) and 73 men (62.4%), with a mean age of 67.36±15.74 years (range 25-99). Of these patients, 95 suffered from cholelithiasis and 22 had no intravesicular content that would justify cholecystitis. Twenty-nine patients (24.8%) had related diseases. Of the 117 patients, 86 met the criteria for mild cholecystitis Tokyo (grade I), 26 met the criteria for moderate cholecystitis (grade II), and 5 met the severe cholecystitis criteria (grade III).

Therapeutic approach

Fig. shows the therapeutic approach taken and the clinical changes of the study population. Surgery was ruled out in 12 (10.3%) of the 117 patients because of high surgical risk (11 patients) or their refusal to undergo the intervention (1 patient). Early cholecystectomy was performed in 31 patients (26.5%) and delayed cholecystectomy in 74 (63.2%).

Fig.Therapeutic approach taken and the clinical progress of the study population.

Of the 74 patients initially selected for delayed cholecystectomy, one died 7 days after admission as a result of septic shock secondary to cholecystitis, and 28patients (37.8%) required cholecystectomy prior to the envisaged date, owing to failure of medical treatment (21 patients) or a new episode of acute cholecystitis while waiting for elective cholecystectomy (7 patients).

Of the 45 patients who should have undergone elective cholecystectomy 6-8 weeks after the initial episode, only 26 underwent surgery. When the study ended, the remaining 19 patients had not yet undergone any intervention, despite the fact that a mean of 144.82 days had elapsed since the initial episode of cholecystitis.

Early versus delayed cholecystectomy

No differences were observed between the 31 patients selected for early cholecystectomy and the 74 patients selected for delayed cholecystectomy, in terms of age (64.06±16.12 vs 66.92±15.50 years), women (29.0% vs 43.8%), and severity of cholecystitis or related comorbidity (16.1% vs 23.3%). Similarly, there were no differences in surgical complications or conversion to open surgery.

Surgical complications according to Clavien classif i cation were described as 7, 3 bleeding (grade III), bile leakage (grade III), pericholecystic collection (grade II), infection of the surgical bed (grade I) and one death (grade V).

Total mean hospital stay was statistically shorter in the early versus the delayed cholecystectomy patients (8.32±4.98 vs 15.96±8.89 days) (Table 1).

The patients selected for early cholecystectomy underwent the intervention 1.40±4.54 days after admission to the hospital, and the time after surgical recovery to discharge was 6.92±3.34 days.

Among the patients selected for delayed surgery, notable differences in total hospital stay were shown by subgroup. Patients who underwent delayed surgery at the appointed time (n=26) registered a total mean stay of 15.96±8.89 days, made up of a pre-surgical stay of 10.78±5.69 days (corresponding to the medically treated episode of acute cholecystitis) plus a post-surgical stay of 4.70±3.94 days (corresponding to subsequent elective cholecystectomy). Those who required emergency performance of delayed cholecystectomy registered a total mean stay of 17.50±13.60 days, corresponding to a pre-surgical stay of 7.62±8.07 plus a post-surgical stay of 9.88±10.23 days. Patients on whom cholecystectomy was not performed registered a mean stay of 11.26±6.25 days (Table 2).

The mean waiting time from date of admission after the initial episode of acute cholecystitis to date of intervention was 89.67±80.08 days. The time for total problem resolution was 8.32±4.98 days in the early cholecystectomy group and 100.11±67.64 days in thedelayed cholecystectomy group.

Table 1.Early versus delayed cholecystectomy

Table 2.Stays according to delayed cholecystectomy subgroup (day)

Factors associated with early versus delayed cholecystectomy

None of the factors assessed was associated with the decision to perform early or delayed cholecystectomy, with patients' characteristics in terms of age, gender, comorbidity and origin of cholecystitis, which were similar in both groups (70.97% lithiasic cholecystitis in group of early cholecystectomy and 87.67% in group of delayed cholecystectomy).

Factors associated with emergency performance of delayed surgery

The sole factor associated with the need to perform emergency surgery due to failure of medical treatment or symptomatic recurrence was the appearance of a complication (bladder perforation, emphysematous cholecystitis, severe sepsis, formation of large pericholecystic fl uid collections or liver abscesses) (Table 3).

Compared with patients who underwent elective cholecystectomy at the appointed time, thosewho required emergency performance of delayed cholecystectomy had a higher incidence of surgical complications (10.71% versus 7.69%) (P<0.05), and open surgery and laparoscopic surgery were converted to open surgery more often (28.57% versus 7.69%, and 14.29% versus 7.69%, respectively) (Table 4).

Table 3.Factors associated with emergency performance of delayed surgery

Table 4.Delayed cholecystectomy performed as scheduled versus emergency performance of delayed cholecystectomy

Long-term follow-up

After a mean follow-up of 14.35±3.75 months after resolution of the acute cholecystitis episode, 4 patients presented with the following complications: acute pancreatitis in two patients, acute pancreatitis associated with cholangitis in one, and recurrent episodes of pain in the right hypochondrium in one. All of them were likely linked to post-cholecystectomy syndrome. The four patients had been selected for delayed cholecystectomy and had received cholecystectomy.

Discussion

The benef i ts reported by randomised prospective studies of early cholecystectomy in the treatment of acute cholecystitis are also evident under the routine working conditions of a hospital like ours, i.e., one that is neither specially dedicated to the surgical treatment of acute cholecystitis nor provided with specif i c management guidelines for this condition.

The clinical reality at our hospital is similar to that elsewhere. The reported rate of early cholecystectomy is 27% for patients with acute cholecystitis, which is comparable to 28% reported by Bhatacharya[28]and Knight.[36]It is also similar in the USA (12%-30%),[29-31]United Kingdom (20%)[32]and Japan (46%).[33]Our results are similar to those of prospective studies, i.e., the conversion rate of early cholecystectomy-open surgery is 16.17%. In these studies, the conversion rate of early cholecystectomy-open surgery ranged from 8% to 25%, which is similar to the rate of 20.3% described in the 2006 Cochrane review.[37]

In our study, hospital stay was slightly longer than that reported in randomised clinical trials (8.32±4.95 versus 1.6±7.6 days for early cholecystectomy, and 15.96± 8.89 versus 2.7±11.6 days for delayed cholecystectomy). This fi nding ref l ects the diff i culties in making an early diagnosis and the operating-theatre related problems. Although hospital stay was longer in both groups, a reduction of over 4 days in mean hospital stay was evident in patients who underwent cholecystectomy early.[12,14,15]

Despite the good results of clinical trials, why early cholecystectomy has not been widely used is due to these results are out the focus of the prospective study. There are few retrospective studies on the results of early cholecystectomy compared with delayed cholecystectomy. The results of early cholecystectomy performed as standard practice for acute cholecystitis were reported in 2007.[35]But it cannot be recognized as a standard practice because it not only fails to include all patients with acute cholecystitis but also exerts an inf l uence on certain factors which might bias the results.

The characteristics of the patient or acute cholecystitis episode is not the reason for the performance of early or delayed cholecystectomy since there were no differences in age, gender, related comorbidity or origin of cholecystitis between the designated early- and delayed-cholecystectomy groups in our study. As there were no differences in the characteristics of the patients or cholecystitis episodes, it is diff i cult to trace the precise reasons that led the surgical team to perform early or delayed cholecystectomy for each patient.

The weakness of the present study is sample size, but it is enough for ascertaining whether early cholecystectomy is benef i cial in standard practice. It would be desirable to study extraneous factors inf l uencing therapeutic decisionmaking, yet it is diff i cult to assess retrospectively such factors as operating-theatre or operating-staff availabilityand surgical workload at any time point.

In brief, early cholecystectomy for acute cholecystitis is superior to delayed cholecystectomy under routine working conditions in a hospital, where therapeutic decisions are biased by neither special surgical dedications nor the presence of guidelines.

Contributors:BM and RE have had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors made the study concept and design. BM and RE made the analysis and interpretation, and drafted the manuscript. All authors made the critical review of the manuscript for important intellectual content. BM is the guarantor.

Funding:None

Ethical approval:Not needed.

Competing interest:No benef i ts in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. The authors declare that they have no conf l icts of interest.

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Received February 25, 2012

Accepted after revision August 30, 2012

AuthorAff i liations:Health Research Institute, San Carlos Clinical Hospital, Department of Medicine, School of Medicine, Complutense University, Madrid 28040, Spain (Barceló M, Cruz-Santamaría DM, Alba-López C, Devesa-Medina MJ, Díaz-Rubio M and Rey E)

Marta Barceló, MD, Servicio de Aparato Digestivo, Hospital Clínico San Carlos, c/Martin Lagos s/n, Madrid 28040, Spain (Tel: 34-699915879; Email: marta.barcelo@yahoo.es)

? 2013, Hepatobiliary Pancreat Dis Int. All rights reserved.

10.1016/S1499-3872(13)60011-9