|Year : 2019 | Volume
| Issue : 4 | Page : 1267-1271
Is it safe to do laparoscopic cholecystectomy for acute cholecystitis up to 7 days?
Mohamed M Abdalgaleil1, Ahmed M Shaat2, Osama S Elbalky1, Mamdouh M Ibrahim1, Mohamed S Elnagaar1
1 Department of General Surgery, Damanhour Teaching Hospital, El Beheira, Egypt
2 Department of Anesthesia, Damanhour Teaching Hospital, El Beheira, Egypt
|Date of Submission||22-Jun-2019|
|Date of Decision||08-Jul-2019|
|Date of Acceptance||25-Aug-2019|
|Date of Web Publication||31-Dec-2019|
Mohamed M Abdalgaleil
Kafr Eldawar, El Beheira 22625
Source of Support: None, Conflict of Interest: None
The aim was to compare the safety of early (≤72 h) vs late (>72 h to 7 days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).
As LC within 72 h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC for patients with AC who failed to have LC within 72 h of acute attack.
Patients and methods
This was a prospective randomized comparative study carried out on 120 patients presented with AC at Damanhour Teaching Hospital, El Beheira, Egypt, between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC: group E: within 72 h of symptom onset, and group L: after 72 h up to 7 days from symptom onset.
There were no statistically significant differences between both groups regarding demographic data, American Society of Anesthesiologist physical status, history of previous upper abdominal operations, conversion to open cholecystectomy, postoperative complications, and hospital stay. Operative duration and intraoperative blood loss were significantly higher in group L than group E.
Extending the golden time for LC up to 7 days of acute attack was safe and feasible. It was associated with the same open cholecystectomy conversion rate, postoperative complications rate, and length of hospital stay; however, the operative duration and intraoperative blood loss were significantly increased. We highly recommend a well-trained laparoscopic surgeon to perform the procedure for patients' safety.
Keywords: acute cholecystitis, early laparoscopic cholecystectomy, gallbladder disease, late laparoscopic cholecystectomy
|How to cite this article:|
Abdalgaleil MM, Shaat AM, Elbalky OS, Ibrahim MM, Elnagaar MS. Is it safe to do laparoscopic cholecystectomy for acute cholecystitis up to 7 days?. Menoufia Med J 2019;32:1267-71
|How to cite this URL:|
Abdalgaleil MM, Shaat AM, Elbalky OS, Ibrahim MM, Elnagaar MS. Is it safe to do laparoscopic cholecystectomy for acute cholecystitis up to 7 days?. Menoufia Med J [serial online] 2019 [cited 2020 Apr 4];32:1267-71. Available from: http://www.mmj.eg.net/text.asp?2019/32/4/1267/274234
| Introduction|| |
Acute cholecystitis (AC) is one of the most common surgical emergencies . Laparoscopic cholecystectomy (LC) is now the most common procedure performed for AC with acceptable results . Although operation within 'golden 72 h' from symptom onset has been suggested for AC, such early surgery is hardly possible in clinical practice because of variable timing of presentation , and for a variety of reasons, referring to both patients and physicians . So, till now the optimal timing of LC for AC is controversial , as the early period is recently extended up to 7 days . The aim of this study was to evaluate the safety and surgical outcomes of LC for AC within and after 72 h up to 7 days of symptom onset.
| Patients and Methods|| |
After obtaining approval from the Local Ethics Committee, written consent was obtained from each patient to participate in the study. This was a prospective randomized comparative study carried out on 120 patients with AC at Damanhour Teaching Hospital, El Beheira, Egypt, between September 2017 and April 2019. Patient selection for this study was based on clinical diagnosis, ultrasonographic findings, and laboratory findings suggesting AC. Inclusion criteria were patients with AC within 7 days from symptom onset, American Society of Anesthesiologist physical status I-II, age from 21 to 60 years. Exclusion criteria included; patients withAmerican Society of Anesthesiologistphysical status more than II, age less than 21 years or more than 60 years, Child–Turcotte–Pugh classification B or C, choledocholithiasis, acute pancreatitis, severe sepsis, gallbladder perforation, and pregnant women. Patients were randomly allocated into two equal groups: in group E, early LC (within 72 h from symptom onset) was done, whereas in group L, late LC (after 72 h ≥7 days from symptom onset) was done. All patients in the study were subjected to clinical assessment in the form of complete history taking, clinical examination, abdominal ultrasonography, and laboratory investigations in the form of complete blood picture, coagulation profile, liver function tests, kidney function tests, blood glucose level, alkaline phosphatase, C-reactive protein, serum amylase, and serum lipase. The operative technique was limited to four senior surgeons with more than 10 years of experience in laparoscopic surgery and have sufficient surgical skills to accomplish LC for AC. Under standardized general anesthesia with endotracheal intubation and controlled mechanical ventilation, LC was performed by the four-port technique. In brief, after peritoneal insufflation, the gallbladder was decompressed by aspirating bile, the cystic artery and cystic duct were freed, and the critical view of safety was created in each case. The cystic duct and artery were clipped and dissected, a tubal drain was routinely left at gallbladder bed after thorough saline lavage and suction, and finally, port-site wound closure was done. Demographic data (age, sex, weight, height, and BMI), ASA physical status, history of previous upper abdominal operations, operative duration, intraoperative blood loss, conversion to open cholecystectomy (OC), and length of hospital stay were recorded. Follow-up of patients was done by serial clinical examination. Postoperative complications were defined during 30 days postoperatively and recorded, such as postoperative bleeding, fluid collection, bile leak, portsite infection, revision surgery, and mortality rate. The primary outcome variable of this study was postoperative complications rate, and the secondary outcome variables were operative duration, intraoperative blood loss, conversion rate, and length of hospital stay. In this clinical trial, after reviewing the literature ,, we found that with a confidence level of 95% (i.e., α/2 = 0.05, Zα/2 = 1.96) and with a power of 80% (i.e., β=0.2, Zβ=0.84) to detect a 12% increase in postoperative complications (primary outcome variable) between studied groups (i.e. P1 = 0 and P2= 0.12), the sample size was calculated from the following formula: [n=(Zα/2 + Zβ) 2×(P1 (1 − P1)+P2 (1 − P2))/(P1 − P2)2] and determined that at least 58 patients were required per group. We included 60 patients in each group to allow for dropouts and protocol violation. The sample was randomly allocated by random allocation software program, version 1. Charts were drawn using Microsoft Excel (Microsoft Office Professional Plus for Windows PC 2016, 64-bit; Microsoft Corp., Redmond, Washington, USA). Data were statistically analyzed using statistical package for social science program (IBM SPSS Statistics for Windows 2011, Version 20.0; IBM Corp., Armonk, New York, USA). Data were tested with Student's t-test for comparison between parametric means and expressed as mean ± SD, χ2-tests for comparison between the incidences and expressed as number of patients (percentage), and Mann–Whitney U test for comparison between nonparametric values and expressed as median (range). A P value less than 0.05 was considered statistically significant, and P valueless than 0.01 was considered highly significant.
| Results|| |
All 120 patients who were recruited and randomized completed the study and were included in the analysis. There were no statistically significant differences between both studied groups regarding age, sex, weight, height, and BMI [Table 1]. There were no statistically significant differences between both studied groups regarding ASA physical status and history of previous upper abdominal operations. The mean operative duration was prolonged in group L (76.67 ± 23.301 min) than in group E (53.33 ± 9.508 min), with a mean difference of 23.34 min, and was highly statistically significant [Figure 1]. The mean intraoperative amount of blood loss was increased in group L (182.50 ± 50.376 ml) than in group E (67.58 ± 52.364 ml) with a mean difference of 105.92 ml and was highly statistically significant [Figure 2]. The length of hospital stay in patients of group E ranged between 1 and 14 days, with a mean value of 1.47 ± 1.732 days, whereas in group L, it ranged between 1 and 15 days, with a mean value of 2.05 ± 1.780 days, with no statistically significant differences between both groups [Table 2]. Three (5%) cases in group E were converted to open approach: two of them were due to obscure anatomy and one case was due to excessive bleeding. However, six (10%) cases in group L were converted to open approach: three of them were owing to difficult anatomy and three cases were owing to excessive bleeding, with no statistically significant difference between both groups regarding the rate of conversion to open approach. Four (6.7%) cases in group E experienced postoperative complications in the form of postoperative bile leak in one (1.7%) case, which appeared on the first postoperative day, with no identifiable cause after thorough investigations and was managed conservatively till it stopped spontaneously on the 14th postoperative day. And also there were port-site infections in three (5%) cases. The remaining cases of this group passed without complications. In contrast, eight (13.3%) cases in group L experienced postoperative complications: three (5%) of them were complicated by postoperative bile leak, where one case experienced bile leak from cystic duct owing to slipped clips, which appeared on the fifth postoperative day and was managed by ultrasound-guided drainage and stenting with endoscopic retrograde cholangiography endoscope and discharged on the 15th postoperative day, and two cases from the gallbladder bed, which appeared on the second postoperative day and managed conservatively; moreover, there were five (8.3%) cases with port-site infection. The remaining cases of this group passed without complications. All cases of port-site infection occurred at the umbilical port where the gallbladder was retrieved. There were no statistically significant differences between both groups regarding postoperative complications rate, and there were no incidences of postoperative bleeding, fluid collection, revision surgery, or mortality [Table 3].
|Figure 1: Differences in operative duration between the two studied groups.|
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|Figure 2: Differences in intraoperative blood loss between the two studied groups.|
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|Table 2: American Society of Anesthesiologist physical status, previous upper abdominal operations, operative duration, intraoperative blood loss, and hospital stay duration|
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| Discussion|| |
AC is the most common infectious disease of the gallbladder. It is initiated by three main mechanisms: cystic duct obstruction by gallstones, lysolecithin release, or ascending bacterial infection . Formerly, LC for patients with AC was intended 6–8 weeks after clinical improvement of acute inflammatory attack to permit amelioration of the acute phase reaction of the gallbladder . Conservative treatment for AC followed by delayed cholecystectomy was associated with many events . Approximately 20–26% of admitted patients would not respond to medical treatment or develop instantaneous complications and require a pressing and technically challenging cholecystectomy. Unfortunately, ∼15–30% of discharged home patients would be readmitted with recurrent manifestations and undergo an unplanned emergency cholecystectomy . At the time of delayed operation, dense fibrotic adhesions at Calot's triangle make interval LC difficult and risky . According to the updated Tokyo Guidelines 2013 (TG13), the optimal treatment for AC is early LC when less than 72 h have passed since symptom onset . Beyond 72 h of symptom onset, late LC for AC is controversial because of greater operative difficulty, so elective surgery has been recommended several weeks after AC; alternatively, careful LC may be performed by an expert team . The definition of 72 h for early LC has recently been changed, as the early period is now defined as 24 h to 7 days, based on multicenter randomized controlled studies . Few retrospective studies have compared the outcomes of LC implemented within and after 72 h of symptom onset ,,,,,, and some previous studies concluded safety of LC within seven days of symptom onset ,,,. Zhu et al.  performed a retrospective clinical study on 133 patients in China, and they found statistically significant prolongation of operative duration (66.4 ± 3.05 min) in late (>72 h to 7 days) LC group vs (44.1 ± 5.32 min) in early (≤72 h) LC group, which agreed with our results. On the contrary, a retrospective clinical study in Japan showed no significant difference between early and late LC groups regarding mean operative duration . We found that they excluded patients with history of previous upper abdominal surgery and patients with technical difficulty of performing laparoscopic procedures leading to selection bias and affecting evaluation of the results. Our results concedes with that of Shinke et al. , which declared statistically significant increase in the mean intraoperative blood loss (140 ± 184 ml) in late (>72 h to 7 days) LC group vs (69 ± 107 ml) in early (≤72 h) LC group. The increase of local inflammation in the gallbladder over several days may lead to hardening of the gallbladder wall, resulting in increased intraoperative blood loss; however, it did not influence the postoperative course, which was clinically and hemodynamically insignificant . Gallbladder inflammation during the first 72 h of symptom onset may not involve structures within Calot's triangle; therefore, surgical dissection during LC within this critical period appears easiest, owing to lack of organized adhesions and reduces the risk of injury to the structures within Calot's triangle . Asai et al.  performed a retrospective analysis and propensity score matching of medical records of 82 patients in Japan. They reported no significant difference between both groups regarding median operative duration and intraoperative blood loss, which disagreed with our results. We found that they performed preoperative gallbladder drainage in 36.6 and 29.3% of early and late group patients, respectively; moreover, the median surgeon experience was 14 (7–25) years, which shortened the operative duration and decreased the amount of blood loss in the late group. Conversion from LC to OC is considered important to guard against bile duct injury resulting from obscure anatomy. Patients presented with AC have a greater chance of a laparoscopically completed cholecystectomy if operated on by a laparoscopy-oriented surgeon . The combined results of two retrospective studies in Japan ,, which evaluated 315 patients, found that there were no significant differences in OC conversion rate and overall postoperative complications when comparing early (≤72 h) and late (>72 h to 7 days) LC groups in their studies, which were similar to our results. Our results were comparable with that of Qureshi et al. , which reported no statistically significant difference in the rate of postoperative bile leak between early and late LC groups. Three previous studies showed no statistically significant difference in port-site infection rate between early and late LC groups ,,, which go along with our results. On the contrary, a retrospective analysis of prospectively collected database of 61 patients in India, who were categorized into two groups, early (≤72 h) LC 21 patients and late (>72 h to 7 days) LC 40 patients, showed no significant difference between both groups regarding mean operative duration, and there was neither conversion to OC nor postoperative complications in their study . We suggest that these results were owing to the small sample size of their study. Five clinical studies consisting of a total of 573 patients, found no statistically significant differences in the length of hospital stay between early (≤72 h) and late (>72 h to 7 days) LC ,,,,, which were in line with our results. A retrospective descriptive study of clinical records of 164 patients in Pakistan showed there were statistically significant increases in conversion rate, postoperative complications rate, and mean length of hospital stay in late LC group than in early LC group , which were incomparable with our results. We suggest that high conversion rate could be owing to lack of experience in LC for AC, leading to increase in postoperative complications and consequently prolonged hospital stay.
| Conclusion|| |
From this study, we declare the safety and feasibility of extending the 72 h golden time of LC for AC up to 7 days from the onset of symptoms. It is associated with the same conversion rate, postoperative complications rate, and length of hospital stay. However, the operative duration and intraoperative blood loss were significantly increased. We highly recommend a well-trained laparoscopic surgeon to perform the procedure for patient safety.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]