Comparison of early and delayed laparoscopic cholecystectomy for acute cholecystitis--experience from a single centre.
Biliary diseases constitute a major portion of digestive tract disorders. Among these is cholelithiasis, which causes general ill health and hence requires surgical intervention for total cure.  Gallstone disease is three times more common in women than men. With advancing age, prevalence increases from 4% in the third decade of life to 27% in the seventh decade of life.  Acute cholecystitis is a major complication of gallstones. Cholecystectomy remains the treatment of choice for gallstone disease. Open cholecystectomy remains the gold standard for symptomatic cholelithiasis for over a century. However, in the last decade, the introduction of laparoscopic technique to perform cholecystectomy has revolutionised this procedure and the latter became the gold standard procedure. The first laparoscopic cholecystectomy was performed in 1985 by Muhe and a report was presented in the German Surgical Society in 1986. However, Reddick and Oslen devised the currently used method for laparoscopic cholecystectomy while performing their first case in September 1988. [3,4] Laparoscopic cholecystectomy was thus performed as an elective procedure and achieves the goal of shorter recovery time, decreased expense, less postoperative pain and improved cosmesis.  Several randomised studies in the prelaparoscopic era had shown that early open cholecystectomy for acute cholecystitis was better than delayed open cholecystectomy in terms of shorter hospital stay, but both had similar operative mortality and morbidity. [5-9] Early surgery for acute cholecystitis had since gained popularity in the late 1980s. In the early years of minimally invasive surgery, acute cholecystitis was considered to be a relative contraindication to laparoscopic cholecystectomy because of inflammatory changes making dissection difficult and because of friability of tissues and ill-defined surgical planes. In acute phase, the oedema may spread into the triangle of Calot or it may stop at the fundus of gall bladder, leaving Calot's triangle reasonably free of inflammation. When acute inflammation matures to chronic inflammation, neovascularity, fibrosis and contraction makes laparoscopic cholecystectomy substantially more difficult and potentially more dangerous. In general patients who have acute cholecystitis, laparoscopic cholecystectomy should be performed as soon as convenient within the first seven days. There is no benefit in attempting to 'cool off' the gallbladder before proceeding to the operating room. Laparoscope or no laparoscope, the message remains the same: For acute cholecystitis, get it while it is hot. 
Laparoscopic cholecystectomy for acute cholecystitis has still not become routine because the timing and approach to the surgical management in patients with acute cholecystitis is still a matter of controversy.  Several studies have concluded that cholecystectomy for acute cholecystitis should be carried out during 72 hours of admission [11,12] with an advantage to decrease the morbidity and mortality of patients due to complications who would otherwise need repeated admissions for recurrent symptoms.
This prospective randomised study was undertaken to evaluate the safety and feasibility of laparoscopic cholecystectomy for acute cholecystitis and compare the results with those of delayed cholecystectomy.
MATERIALS AND METHODS
This was a prospective and comparative study conducted in the Department of Surgery, Gauhati Medical College and Hospital, Guwahati, from July 2015 to June 2016. The study was approved by Hospital Ethics Committee.
The study comprised 104 cases (64 in early group and 40 in delayed group). Before the procedure, fully informed consent was taken. Patients were fully informed that the gallbladder and stones will be removed. Additionally, patients' consent for conversion to an open procedure was obtained.
All patients were subjected to laparoscopic cholecystectomy. All the patients who were admitted with a diagnosis of acute cholecystitis were informed regarding early and interval cholecystectomy; 64 out of total 104 opted for early laparoscopic cholecystectomy within seven of onset of symptoms and rest 40 opted for initial conservative treatment followed by delayed interval surgery 6-12 weeks later.
The diagnosis of acute cholecystitis was based on the finding of acute upper abdominal pain with acute right upper quadrant tenderness, associated nausea or vomiting, fever (> 1000F) and ultrasonographic (USG) evidence of acute cholecystitis such as distended gall bladder, presence of gallstones with a thickened and oedematous gallbladder wall, positive Murphy's sign and pericholecystic fluid collections. In addition, increased total leukocyte count (> 10,000/[mm.sup.3]) in such patients was taken as an inclusive criterion for acute cholecystitis.
The initial supportive treatment during the acute phase was same for both groups of patients. All patients received intravenous (IV) fluid infusion and IV antibiotics. Patients excluded from the study were those with surgical jaundice (bilirubin level above 3.5 mg/dL), USG proved choledocholithiasis, malignancy, preoperatively diagnosed acute gallstone induced pancreatitis, previous upper abdominal surgery, significant medical disease rendering them unfit for laparoscopic surgery and those who refused to undergo laparoscopic surgery.
On admission, a detailed history was taken. Thorough general physical examination and systemic examination was done for every patient. Relevant investigations were done, which included complete haemogram, blood urea, serum creatinine, blood sugar, serum electrolytes, liver function test, serum amylase and lipase, x-ray chest, electrocardiogram and USG abdomen.
The operation was performed by consultant and the surgery was done with the patient under general anaesthesia. Pneumoperitoneum was created by blind puncture with a Veress needle through an infraumbilical incision. Four laparoscopic ports were used: two 10 mm ports (one umbilical 10 mm port for the optical system and one epigastric port for the dissector/suction device) and two 5 mm ports (one at the midclavicular line along the right subcostal margin and one in the right flank. Adhesion release and exposure of Calot's triangle were first undertaken. If necessary, the gallbladder was emptied through a laterally inserted Veress needle to allow better grasping. The cystic pedicle was dissected to isolate the cystic duct and the artery separately. Both were then clipped and divided. The gallbladder was dissected off its bed with a monopolar cautery hook. Use of harmonic was taken wherever necessary. At completion of the surgery, the gallbladder was extracted through the epigastric incision, which was enlarged if necessary. Haemostasis was achieved in gallbladder bed and after a thorough saline lavage a suction drain was placed if clinically indicated and the incisions closed. When required, conversion to the open procedure was performed through a right subcostal incision.
Postoperatively, the patients were allowed oral intake 6-12 hrs. after surgery, provided they had no nausea or vomiting. The single dose of antibiotics was repeated. Pain relief was obtained by intramuscular ketorolac injection, which was changed to tablet administration once patient was allowed orally. The patients were discharged once the drain was removed and the patient was afebrile and taking nutrition orally.
All data obtained were entered into the database and analysed by means of Statistical Package for Social Sciences (SPSS) software using appropriate statistical tests like Fisher's exact test or unpaired 't' test as and when needed. A P value of less than 0.05 was considered significant.
The study comprised 104 cases (64 in early and 40 in delayed group). Age distribution in both groups was comparable with no statistically significant difference observed (P = 0.8458). The mean age of patients in the early and delayed groups was 36.82 years and 37.22 years, respectively. Out of 104 cases, 27 were male and 77 were female. The male: female ratio was 1:2.8, and the difference between the two groups was statistically not significant (P > 0.05).
Clinical Profile and Laboratory Investigations of Patients in the two Groups
Pain Right Hypochondrium (RHC) was present in all patients. Nausea/vomiting was present in 53 patients in the early group and 36 patients in the delayed group. Fever was noted in 41 patients in the early group and 21 patients in the delayed group. Six patients presented with an additional history of RHC lump. However, no statistically significant difference was observed in the presentation between the two groups (P > 0.05). Symptoms and findings of physical examination of patients in the two groups are presented in Table 1 and 2. Routine blood investigations and ultrasonographic parameters of patients in the two groups are shown in Tables 3 and 4, respectively.
Operative Procedures and Operating Time
More modifications in the operation technique (Table 5) and a longer operation time were required in the early group than in the delayed group. The mean operating time was 112 mins. (range, 40-210 mins.) in the early group and 81 mins. (range, 35-200 mins.) in delayed group. The difference in operation time was not statistically significant (p = 0.386). The average blood loss was 238 mL in the early group and 125 mL in the delayed group (p < 0.0001). No patient in either groups required blood transfusion. Intraoperative blood loss was estimated by measuring suction canisters pre- and postoperatively and subtracting the amount of irrigation used from it.
Conversion to Open Surgery
Ten patients (16%) in early group and five patients (12.5%) in delayed group underwent conversion to open surgery (p = 0.7784). The main reasons for conversion in the early cases were technical including one case each of unclear Calot's triangle anatomy, suspicion of bile duct injury, minor bile duct injury and transection of gallbladder at Hartmann's pouch. The main reason for conversion in the delayed group involved dense adhesions around Calot's triangle and gallbladder, making dissection difficult.
Postoperative complications in the two groups are shown in Table 6.
The mean total hospital stay was 9.84 days (range, 7-15 days) in the early group and 16.4 days (range, 12-22 days) in the delayed group. This difference was statistically significant (p = 0.0001). However, the mean postoperative hospital stay was 5.9 days (range, 4-11 days) in the early group and 5.8 days (range, 3-12 days) in the delayed group (p = 0.8040).
Laparoscopic surgery has radically changed the field of general surgery, and with increasing experience its applications are expanding rapidly. It has become the standard of care for symptomatic cholelithiasis. The pioneers of laparoscopic cholecystectomy initially considered acute cholecystitis to be a contraindication for laparoscopic surgery.  The main reason for a conservative approach was the concern of having a high risk of common bile duct injury due to oedematous and inflamed tissues obscuring the anatomy in the Calot's triangle. However, with growing experience and greater technical skills, surgeons realised that these obstacles could be managed. Consequently, an increasing number of reports became available, demonstrating the feasibility of the laparoscopic approach for acute cholecystitis with an acceptable morbidity. 
The general belief that initial conservative treatment increases the chance of successful laparoscopic cholecystectomy at a later date probably is not true, as borne out by this study. In our study, both the early and delayed groups had not significant conversion rates. The reasons for conversion, however, were different. In the early group, the friable and oedematous gall bladder tore when grasped. Moreover, there was excessive oozing attributable to acute inflammation. However, in delayed group, the main reason for conversion involved dense adhesions obscuring the anatomy of Calot's triangle. Although our 16 percent conversion rate in early group seems to be high, it reflects our safety concerns for the method, and we believe that more experience with early surgery for these cases may bring the conversion rate down.
An important issue in comparison of the two groups is the bile duct injury. None of the patients in either groups had bile duct injury. Two patients had bile leak in the early group due to distal partial obstruction by a small stone in distal common bile duct, which had slipped off gallbladder during dissection and was successfully removed by Endoscopic retrograde cholangiopancreatography (ERCP) and the leak settled.
Most surgeons agree that timing of the procedure is an important factor in determining outcome. Ideally, the surgery should be performed as soon after admission as possible. Although, operation within the "golden 72 hrs." from the onset of symptoms has been suggested, [15,16,17,18,19] such early surgery is not always possible in clinical practice because there are logistic difficulties in performing surgery for such patients on an emergency basis. We performed the surgery for the patients in the early group according to the next available elective operating list. As a result, all the early group patients underwent cholecystectomy within seven days of onset of symptoms.
Several technical key points must be kept in mind when laparoscopic surgery is performed for acute cholecystitis. For good exposure of Calot's triangle, decompression of the gallbladder should be done early because this allows better grasping and retraction of the gallbladder. In our study, during early surgery a thickened and oedematous gall bladder was encountered in all cases who underwent early operation, which posed a difficulty in grasping and retraction of the gall bladder and also obscured the Calot's triangle. Decompression of gallbladder was done to visualise the anatomy of Calot's triangle was done in 50 (78 percent) cases. A subhepatic drain was placed in 51 (80%) patients in the early group and in 9 (22.5%) patients in the delayed group. The reason for this was spillage of bile and stones during dissection of gallbladder from liver bed.
The average blood loss was more in the early group than in the delayed group; however, no patient required blood transfusion. The difference could be attributed to more vascularity around gallbladder and Calot's triangle in acute phase.
Our experience supports the belief that the inflammation associated with acute cholecystitis creates an oedematous plane around the gallbladder, thus facilitating its dissection from the surrounding structures. Waiting for the inflamed gallbladder to cool down allows maturation of the surrounding inflammation and results in organisation of the adhesions, leading to scarring and contraction, which make the dissection more difficult. Also, although inflammation in early stages may not necessarily involve Calot's triangle, chronic inflammation often scars and distorts Calot's triangle, making dissection in this critical area more difficult.
The difference in the operation times was not significant, although early group patients required a longer operation time than the delayed group. However, the total hospital stay in the delayed group, which included the total time spent during two admissions was significantly longer than in the early group.
The safety and efficacy of early and delayed laparoscopic cholecystectomy for acute cholecystitis were comparable in terms of mortality, morbidity and conversion rate. However, early laparoscopic cholecystectomy allows significantly shorter total hospital stay and reduction in days away from work at the cost of significantly longer operating time and blood loss and offers definitive treatment at initial admission. Moreover, it avoids repeated admissions for recurrent symptoms.
In conclusion, early operation within seven days of onset of symptoms has both medical and socioeconomic advantages and should be the preferred approach for patients managed by surgeons with adequate experience in laparoscopic cholecystectomy.
Financial or Other, Competing Interest: None.
Submission 20-11-2016, Peer Review 14-12-2016, Acceptance 20-12-2016, Published 26-12-2016.
Dr. Purujit Choudhury, P. O. Gopinath Nagar, Arya Path, Gauhati-781016, Assam.
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Purujit Choudhury (1), Shashank Agrawal (2)
(1) Associate Professor, Department of Surgery, Gauhati Medical College, Assam.
(2) Junior Resident, Department of Surgery, Gauhati Medical College, Assam.
Table 1. Comparison of Symptoms in Two Groups Symptoms Early (n = 64) Delayed (n = 40) P value Pain abdomen 64 40 1.0000 Nausea & vomiting 53 36 0.3966 Fever 41 21 0.3052 Lump 06 04 1.0000 Table 2. Comparison of Physical Findings in Two Groups Examination Early (n=64) Delayed (n=40) P value Tender RHC * 64 40 1.0000 Murphy's sign 24 17 0.6818 Fever (>1000F) 26 14 0.6795 RHC Lump 08 05 1.0000 Jaundice 0 0 -- Table 3. Routine Blood Investigations of the Patients in Two Groups Investigations Early Delayed P value (n = 64) (n = 40) N (%) N (%) Haemoglobin (< 10 gm%) 6 (9) 3 (7.5) 1.0000 TLC (> [10.sup.3]/cum *) 42 (65) 22 (56) 0.3059 Bilirubin (> 2 mg/dL) 9 (14) 4 (10) 0.7619 SGOT (Deranged) ([gamma]) 11 (17) 06 (15) 1.0000 SGPT (Deranged) ([alpha]) 11 (17) 07 (17) 1.0000 ALP (Deranged) ([infinity]) 8 (12.5) 04 (10) 0.7635 Serum Amylase (Deranged) 0 0 -- Serum Lipase (Deranged) 0 0 -- * Cumm: Cubic millimetre; ([gamma]) SGOT: Serum glutamic oxaloacetic transaminase; ([alpha])SGPT: Serum glutamic pyruvate transaminase; ([infinity]) ALP: Alkaline phosphatase. Table 4. Ultrasonogram Parameters of Patients in the Two Groups USG Finding Early Delayed P value (n =64) (n = 40) N (%) N (%) Thickened (> 4 mm) & 64 (100) 40 (100) 1.0000 Oedematous Gallbladder Distended Gallbladder 54 (85) 30 (75) 0.3075 Presence of Gallstones 59 (92) 38 (95) 0.7045 Pericholecystic Fluid 22 (35) 12 (30) 0.6738 Table 5. Modification of the Operative Technique Modification of Technique Early Delayed P value (n=64) (n=40) N (%) N (%) Gallbladder decompression 50 (78) 02 (5) 0.0001 Subhepatic drain 51 (80) 09 (22.5) 0.0001 Epigastric port enlargement 04 (6) 01 (2.5) 0.6466 Conversion to open 10 (16) 05 (12.5) 0.7784 Table 6. Postoperative Complications in Two Groups Complication Early Delayed P value Wound Infection 12 06 0.7912 Biliary Leakage 02 00 0.5220 Prolonged Ileus 05 00 0.1537 URTI * 02 04 0.2011
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|Title Annotation:||Original Research Article|
|Author:||Choudhury, Purujit; Agrawal, Shashank|
|Publication:||Journal of Evolution of Medical and Dental Sciences|
|Date:||Dec 26, 2016|
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