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Laparoscopic Cholecystectomy for Acute Cholecystitis
MAterIAl And Methods epigastric port enlargement, suction/irrigation, and subhepatic
Patients and Methods closed suction drain placement.
Conversion to open cholecystectomy was done through
This study was a prospective randomized interventional study right subcostal incision during difficulty in dissection, excessive
conducted in the Department of Surgery, at Postgraduate bleeding, and adhesion of Calot’s triangle. The drain was removed
Institute of Medical Sciences and Research and Employee after 24–72 hours postoperatively. Surgical procedures were
State Insurance Corporation Model Hospital, New Delhi, India performed by surgeons having more than 5 years of experience
from October 2017 to February 2019 after approval from the of LC in a single surgical unit. All patients were allowed to eat and
institutional ethical committee. Written and informed consent drink 6–8 hours postsurgery, in the absence of nausea or vomiting.
was obtained from each patient for inclusion in the study, LC, Intramuscular diclofenac injection was advised for pain relief.
and conversion to open. Antibiotics were prescribed as per hospital protocol.
Primary outcome measures were conversion to open surgery,
Inclusion Criteria mean duration of hospital stay, complications (bile leak, bile
Acute cholecystitis patients admitted to the Department of Surgery duct injuries, and postoperative wound infection), and mortality.
of age from 18 to 60 years of either sex, with the American Society The secondary outcome measures were the mean duration
of Anesthesiologists (ASA) grade I and II, were included. Right upper of surgery, intraoperative blood loss, other complications
abdominal pain, temperature more than 98.6°C, total leukoctes (subhepatic collection, postoperative pneumonia), and unsuccessful
counts (TLC) more than 10,000/dL, or both, and presence of gallstones, nonoperative management.
thickened and edematous gallbladder (GB) wall with pericholecystic
fluid were considered as diagnostic criteria. Finally, intraoperative Statistical Analysis
findings were reckoned as diagnostic for acute cholecystitis. The data were entered in an Excel spreadsheet and analyzed by
the Statistical Package for Social Sciences (SPSS) version 21.0.
Exclusiosn Criteria Categorical variables were presented in number and percentage (%).
Exclusion criteria included patients with simple biliary colic, Continuous variables were presented as mean ± standard deviation
obstructive jaundice, choledocholithiasis, gallstone-induced acute (SD) and median. Normality of data was tested by the Kolmogorov–
pancreatitis, post-endoscopic retrograde cholangiopancreatography, Smirnov test. Quantitative variables were compared using the
previous biliary tract surgery, previous abdominal surgery, biliary unpaired t-test/Mann–Whitney test while qualitative variables were
peritonitis, decompensated liver cirrhosis, intra-abdominal abscess, compared using the Chi-square test/Fisher’s exact test. A p value
GB polyp, or malignancy, ASA grade III and IV, refusal of surgery, acute of <0.05 was considered statistically significant.
cholecystitis in pregnancy, and other contraindication to surgery.
Sample Size Calculation results
Sample size calculation was done on the basis of the study of Gutt A total of 145 concordant patients were assessed for the study, out
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et al. in which the overall complications were 14.1 and 40.4% of which 45 patients were excluded as per criteria (Flowchart 1). The
in early group and delayed group, respectively. Considering the comparison group had 50 patients each with post-randomization at
80% power and 5% level of significance, the minimum number the final analysis. As shown in Table 1, both groups were comparable
of patients required was 40 in each group. The sample size was and equally distributed in respect of age, sex, body mass index,
increased by 10% on the basis of the assumption of nonparametric laboratory reports, radiological parameters, and comorbidities.
statics and dropout, and finally we consider 50 patients in each There was no failure of conservative treatment in the delayed group
group. which required urgent surgery. Various parameters were observed
and evaluated pre-, intra-, and postoperatively.
Randomization The physical examination findings were similar in comparison
Block randomization with a sealed envelope system was used. groups. The pain duration, first symptoms, and previous biliary
We prepared randomly generated ten opaque sealed envelopes symptoms were comparable in both the groups. The use of antibiotics
assigning A and B in five blocks each: A represented the ELC group was significantly more common in the DLC group (49; 98%) as
and B represented the DLC group. Patients who underwent LC compared to the ELC group 5 (10%); p <0.001. All patients had pain
within 72 hours of symptoms were included in the ELC group, in right hypochondrium. Murphy’s sign was positive in 45 (90%) and
whereas LC done after 6–12 weeks were included in the DLC 40 (80%) of ELC and DLC groups, respectively. Laboratory findings,
group. These patients were initially managed conservatively viz TLC, Kidney function test (KFT), and liver function test (LFT), were
(broad-spectrum intravenous antibiotics and intravenous fluid comparable in both the groups (Table 1). The ultrasound findings
resuscitation) and discharged when asymptomatic. were also comparable in both the groups (Table 2).
The mean intraoperative time and the mean intraoperative
Data Collection blood loss were significantly higher in the ELC group. The mean
Data were collected from the index admission of patients, which operative time was 77.30 ± 20.078 vs 66.94 ± 29.501 minutes;
included age, sex, associated comorbidities, BMI, past history of (p <0.001) and the mean blood loss 82.60 ± 59.67 vs 65.40 ± 74.21 mL;
biliary disease, history of previous abdominal surgeries, duration (p <0.007) in ELC and DLC groups, respectively. No patients in the
of symptoms, and clinical examination. Other data included comparison groups required blood transfusion.
were laboratory, radiological, intraoperative, and postoperative Conversion to open cholecystectomy and achievement of
parameters. critical view of safety were comparable in both the groups. The
LC was performed by conventional four ports operative adhesion in Calot’s triangle, adhesion with the inferior surface of
technique. Certain modifications were done as and when required, the liver, tensely distended GB, and mucocele/pyocele were more
like GB decompression, use of laparoscopic specimen retrieval bag, common in the ELC group (p <0.010) (Table 3).
150 World Journal of Laparoscopic Surgery, Volume 14 Issue 3 (September–December 2021)