European Journal of Cardiovascular Medicine

Laparoscopic cholecystectomy (LC) is the gold standard operation for gall bladder disease. It is a safe and cost effective procedure, with less post-operative pain and a nearly return to work compared to open surgery [1-3]. It is estimated that over one million patients under go cholecystectomy each year in the USA, mostly on an elective basis [4-7].We can identify four LC setups. The first and probably most practiced is elective LC. The second is LC performed 6 or more weeks following an episode of acute cholecystitis (AC), also termed interval LC (ILC). The third is LC performed during an acute episode of cholecystitis, and the fourth is LC performed following a percutaneous cholecystostomy (PCC) for severely sick high-risk patients .It was our impression that of all these groups, the group of patients undergoing LC following a PCC posed the highest technical difficulties to the operating surgeon and hence the highest con-version and complication rates. Based on this assumption and with the aim to either endorse or negate it, we decided to review our results in operating on these four different groups of patients.

This is a retrospective study performed with the authorization of the Institutional Review Board of our medical center (No.64/12).All patients who under went LC during the period from July 2007 to December 2012 entered the study. The indications for surgery were biliary colic, AC, resolved AC, cholecystocholedocholithiasis (resolved obstructive jaundice, resolved biliary pancreatitis, and resolved ascending cholangitis). Patients who under went LC during another operation such as laparoscopic adjustable gastric banding and any type of colectomy were excluded. Patient records were reviewed and the data was collected in a computerized database. The following parameters were studied: age, sex, comorbidities, length of surgery, need for perioperative blood transfusion, conversion rate, complication rates, length of hospital stay, 30-day readmission rate, and mortality.All operations were performed by the same technique, using a four-trocar technique (2 ×10 mm and 2 ×5 mm), insufflating the abdominal cavity to a maximum pressure of 15 mmHg. The use of drains was based on the senior surgeons' judgment. Drains were taken out within 12-24 h depending on the amount and type of Discharge (bloody/biliary), or left in situ for alonger period of time in cases of biliary discharge until full clearance. Patients were divided into four groups: Group I- patients undergoing elective LC, Group II-patients undergoing interval LC following an episode of AC (average of 15.1 weeks); Group III-patients undergoing LC during an episode of AC; and Group IV-patients undergoing LC following PCC performed in very high-risk patients not fit for surgery or not responding to medical treatment during an episode of AC. Prophylactic antibiotics were used in all operated patients, usually one portion of a third-generation cephalosporin (ceftriax-one 1g, half an hour before surgery, intra-venous). In cases of AC, a combination of antibiotics was used and continued based on clinical grounds (empyema of gall bladder, gangrenous cholecystitis, or perforation). In cases of conversion from LC to open cholecystectomy (OC), the preferred incision was a subcostal incision.

Statistical analysis

In order to compare quantitative (continuous) variables between two independent groups, the two sample t-test was applied as well as the non-parametric Mann-Whitney test. The compari-son of quantitative (continuous) variables between three or more groups was carried out using the ANOVA procedure, with the Bonferroni post hoc test. The association between two categorical variables was assessed using either the Chi-square test or the Fisher's exact test. The logistic regression model was applied in order to test the simultaneous effect of several independent variables on a qualitative, dichotomous dependent variable. All statistical tests applied were two-tailed, and a p-value of 5% or less was considered statistically significant.

Between July 2007 and December 2012, a total of 1658 patients under went LC in our medical center. Group I consisted of 1221 patients (73.6%) who underwent elective LC due to biliary colic or following an episode of biliary pancreatitis or resolved obstructive jaundice. Group II consisted of 271 patients (16.3%) who under went interval LC following an episode of AC. Group III consisted of 125patients (7.5%) operated during an episode of AC. Group IV consisted of 41 patients (2.5%) who underwent LC following a PERICHOLECYSTIC performed during an episode of AC that did not respond to medical treatment or patients at risk for surgery. For the whole cohort of patients, the female to male ratio was 2.44:1 and the mean age 51.0 years (range 17-94). The mean operative time was 45.8±26 min and the median length of hospital stay was 1 day (range 1-67days). There was a 5% (83 patients) conversion rate. Complications occurred in 62 patients (3.7%). The 30-day readmission rate was 4.9% (80 patients).

The demographic data, including comorbidities, operative time, conversion rate, length of hospital stay, complications, and read-mission rate for the four different groups are summarized in Table1. The operative data are listed in Table 2.

The patients of Group IV who underwent PCC were the oldest (67±12 years) and had the highest comorbidity rates (63.4%), while the elective group of patients undergoing LC (Group I) were the youngest (50±17years) and had the lowest comorbidity rates(34%). The difference in mean age was significant (p<0.05). The female/male ratio was significantly different between Group I(3:1 F/M) and the other groups, but this ratio was not significantly different between the other groups (Groups II, III, and IV).

The operative time was significantly different between the groups (p<0.05). It was the shortest in elective LC (39±19 min) and longest in LC following PCC (81 ± 32 min).

The conversion rate was highest in Group III (24.8%). It was significantly higher than for all the other groups (p<0.05).Group II had higher conversion rates (8.5%) than Group I (2.1%) (p<0.05).

The length of the hospital stay was not significantly different between Groups I and II (1.5 and 1.96 respectively), and between Groups III and IV (4.46 and 4.78 respectively). The differences between Groups I and II, and Groups III and IV were statistically sig-nificant (p <0.05).

Complication rates were significantly different between Groups I,II, and III (2.2%,5.6%,and13.6%,respectively) (p<0.05). Group I had the lowest complication rates (2.2%) while Group III had the highest complication rates (13.6%).There were no statistically significant differences between Groups III and IV. There were no significant differences in the 30-day readmission rate between the groups.

Demographic data.

 LC, laparoscopic cholecystectomy; AC, acute cholecystitis; S/P PCC, status post percutaneous cholecystostomy;     HTN, hypertension; IHD, ischemic heart disease; DM, diabetes mellitus.

LC, laparoscopic cholecystectomy; AC, acute cholecystitis; S/P PCC, status post percutaneous cholecystostomy.

a Some patients had more than one complication. However, they were counted as one.

b Acute cholecystitis.

c Percutaneous cholecystostomy.

All clinical presentations of gallstone disease (biliarycolic, biliary pancreatitis, obstructive jaundice, ascending cholang it is followed by clearance of the common bile duct by endoscopic retro grade cholangiopancreatography and AC) are treated by the gold standard procedure-LC. Although performed on a large scale, and based on over 20 years of accumulated experience, LC is not free of complications, one of which is iatrogenicbileduct damage, a devastating complication and a matter of medico-legal litigation[8].

Most LCs are performed on an elective basis for one or more episodes of biliary colic or complicated cholelithiasis, while acertain number, varying from 7% to 9% according to different studies, are performed during an episode of AC or following an episode of AC as ILC[9-11]. Only sporadically is LC performed following a PCC, as this procedure is reserved for very high-risk and elderly patients.

It was our impression that operating following an episode of AC, and especially on the subgroup of patients who underwent a PCC, posed extremely difficult technical problems to the operating surgeon. Based on this assumption, we designed this retrospective study aiming to learn and compare the operative time, conversion rates, complication rates, and readmission of the four different groups presented earlier. A lot of data has been reported on the conversion and complication rates of LC [12-14], but most studies deal with either elective LC or LC performed during AC. To the best of our knowledge ,no study has reported or compared four different set-ups of LC performed by the same team.

Operative time

Not surprisingly, the operative time was shortest in the elective group of operated patients, increasing from 39 ± 19 min to 81 ±32 min in the group of patients who underwent LC following PCC. Our operative time compares well with the data available in the literature for elective LC [9,10,14-16]. Our results show also that the operative time was significantly shorter in Group II (57±32 min) compared with Group III (69±27 min) (p<0.05). Similar data have been reported in other studies [9,10]. We could Not find any data on operative time for patients undergoing LC following PCC.

Conversion rate

For the elective group, the conversion rate was extremely low (2.1%) and this compares very well with another publication [ 12]. However ,our conversion rate in the group of patients operated for AC was as high as 24.8% and compares well to the conversion rates cited in the literature, which are as high as 30% [7,10,11]. On the other hand, the conversion rate in Group II was very low (8.5%) compared with that in the literature. Most studies report that the conversion rate for AC is the same as for ILC [7,10,11]. ILC is technically more difficult to perform than elective LC and there fore the conversion rate is expected to be higher. We were surprised to find that, contradictory to our assumption, the conversion rate in Group IV was lower than expected.

Complications

The complication rate was lowest in the  elective group (Group I-2.2%), and compares well with the reported figures of around 4 % in the literature [9]. The complication rate was significantly lower in Group II (5.6%) compared with Group III (13.6%) (p<0.05).Ac-cording to different studies, there is no difference in the complication rate between the two groups.

Bowel injury resulting in perforation was four times higher in Groups III and IV compared with Groups I and II. We have no explanation for this high rate of complication (0.7%). However, all perforations were recognized during the procedure and repaired with no sequelae for the patients .Bowel injury was also reported in other series, with an incidence of 0.75% [12].

Iatrogenic bile duct injury (IBDI)

During the study period, we encountered one case of IBDI in the ILC group, accounting for an incidence of 0.06% (1/1658). The injury was recognized immediately and repaired by a Roux-en-Yhepaticojejunostomy.

IBDI has remained more or less constant over the 20 years since LC was introduced, with an average rate of 0.3-0.95% [8,9,17].The possible reasons for IBDI and the long-term results of the repair are well known and widely discussed in the literature and are out of the scope of this study [8,17].

We believe that the low rate of IBDI in our series was due to adhering to a strict protocol, especially important in a taching set-up. 

Mortality

Only one of the 1658 operated patients died, accounting for 0.06% of our patients. This was a 91-year-old female admitted for septic shock, who needed vasopressor drugs due to perforated cholecystitis and generalized peritonitis ,and died shortly following cholecystectemy. Reported mortality figures in other series are also very low, ranging from 0.08% to 0.09% [9-11].

ILC/LC during AC

The group of patients with LC during an acute episode of cholecystitis had the worst results. While these results are still comparable with the figures of conversion and complication rates reported in other series [7,10,11], the findings are somewhat contradictory to the better results reported in the literature for LC performed during the first 72 h from the onset of symptoms [5].Forty-two percent of our patients underwent LC more than 72 h after the beginning of their symptoms due to late presentation for treatment or a poor response to conservative treatment. Moreover, a high percentage of our patients presented with signs of sepsis on admission, advocating emergency surgery which was performed in the event of pathological findings of gangrenous cholecystitis (36% of Group III).

A logistic regression model found LC performed in this set-upto

Be an independ ent risk factor for complications (odds ratio [OR] of 2.3 with 95% confidence interval [CI] of 1.14-4.84) and conversion to open surgery (OR of 4.8 with 95% CI of 2.5-9.1).

The debate regarding the timing of surgery inpatients with AC is not yet settled. While some studies favor an emergency operation, other studies show a higher complication rate and there fore recommend the delayed approach [4-7].

Until recently, it was our policy to“cool” patients with AC and operate on them at a later stage by performing ILC. Therefore, the group of patients operated during an episode of AC was a highly selected group of severely sick patients and not the “whole”group of AC patients. Changing the policy and operating all patients presenting with AC of less than 96h seems to lower the conversion and complication rates, but we will need more time to evaluate our results.

Readmission

We were surprised to learn that the readmission rate was 4.2% in the group of elective LC. This rate compared well with that in the literature[13]. The readmission rate was the highest in Group IV(12.2%), as expected.

In conclusion, we defined four different set-ups of LC operated on by the same group of surgeons. To the best of our knowledge, no such classification has been reported in the literature. The highest rates of conversion and complications were in Group III, LC per-formed during AC, contradictory to our assumption that LC following PCC (Group IV) would be the most difficult to perform and hence followed by a high rate of conversion and complications. We found that ILC (Group II) had a medium risk for complications and conversion, with higher rates than the elective LC (GroupI), but lower rates than LC performed during AC (Group III).

1. A. Lujan, P. Parrilla, R. Robles, P. Marin, J.A. Torralba, J. Garcia-Ayllon,Lapa-roscopic cholecystectomy vs. open cholecystectomy in the treatment of acutecholecystitis: a prospective study, Arch. Surg. 133 (1998) 173e175.
2. Kiviluoto, J. Sire´n, P. Luukkonen, E. Kivilaakso, Randomised trial oflaparo-scopic versus open cholecystectomy for acute and gangrenous cholecystitis,Lancet 351 (1998) 321e325.
3. L. Zacks, R.S. Sandler, R. Rutledge, R.S. Brown Jr., A population-based cohort study comparing laparoscopic cholecystectomy and open cholecystectomy ,Am. J. Gastroenterol. 97 (2002) 334e340.
4. Y. Lee, J.J. Carter, M.S. Hochberg, A.M. Stone, S.L. Cohen, H.L. Pachter, Thetiming of surgery for cholecystitis: a review of 202 consecutive patients at alarge municipal hospital, Am. J. Surg. 195 (2008) 467e470.
5. Lau, C.Y. Lo, N.G. Patil, W.K. Yuen, Early versus delayed-interval laparo-scopic cholecystectomy for acute cholecystitis :a metaanalysis, Surg. Endosc.20 (2006) 82e87.
6. M. Lo, C.L. Liu, S.T. Fan, E.C. Lai, J. Wong, Prospective randomized study of early versus delayed laparoscopic cholecystectomy for acute cholecystitis, Ann. Surg. 227 (1998) 461e467.
7. S. Gurusamy, K. Samraj, Early versus delayed laparoscopic cholecystectomy for acute cholecystitis ,Cochrane Database Syst.Rev.(2006)CD005440.
8. M.Targarona,C.Marco,C.Balague´,etal.,How,when,andwhybileduct
9. injury occurs. A comparison between open and laparoscopic cholecystectomy ,Surg. Endosc. 12 (1998) 322e326.
10. R. Scott, K.A. Zucker, R.W. Bailey, Laparoscopic cholecystectomy: a review of12,397 patients, Surg. Laparosc. Endosc. 2 (1992) 191e198.
11. Siddiqui, A. MacDonald, P.S. Chong, J.T. Jenkins, Early versus delayed lapa-roscopic cholecystectomy for acute cholecystitis: a meta-analysis ofran-domized clinical trials, Am. J. Surg. 195 (2008) 40e47.
12. Gurusamy, K. Samraj, C. Gluud, B.R. Davidson, Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis, Br. J. Surg. 97 (2010)141e150.
13. Yi, W.S. Jin, D.B. Xiang, G.Y. Sun, D. Huaguo, Complications of laparoscopic cholecystectomy and its prevention: a review and experience of 400cases,Hepato-Gastroenterology 59 (2012) 47e50.
14. Lau, D.C. Brooks, Contemporary outcomes of ambulatory laparoscopic cholecystectomy in a major teaching hospital, World J. Surg. 26 (2002)1117e1121.
15. J. Shea, M.J. Healey, A.J. Berlin, et al., Mortality and complications associated with laparoscopic cholecystectomy. A meta-analysis, Ann. Surg. 224 (1996)609e620.
16. Banz,T.Gsponer,D.Candinas,U.Güller,Population-basedanalysisof4113patients with acute cholecystitis: defining the optimal time-point for lapa-roscopic cholecystectomy, Ann. Surg. 54 (2011) 964e970.
17. Z. Ahmad, G. Byrnes, S.A. Naqvi, A meta-analysis of ambulatory versus inpatient laparoscopic cholecystectomy, Surg. Endosc. 22 (2008)1928e1934.
18. Waage, M. Nilsson, Iatrogenic bile duct injury: a population-based study of152 776 cholecystectomies in the Swedish inpatient registry, Arch. Surg. 141(2006) 1207e1213.