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COMPARISON OF LAPAROSCOPIC CHOLECYSTECTOMY USING HARMONIC SCALPEL WITH CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY IN PATIENTS OF SYMPTOMATIC GALLSTONES

.. Objectives: To compare the laparoscopic cholecystectomy using harmonic scalpel with conventional laparoscopic cholecystectomy in patients of symptomatic gallstones in terms of mean operative time and mean intra-operative blood loss. Study Design: Randomized Control trial. Setting: Department of Surgical at Allied Hospital Faisalabad. Period: 6 months Oct 2017 to Mar 2018. Material & Methods: Eighty (80) patients (forty in one group) divided randomly into A (harmonic scalpel group) and B (conventional) group, done under general anesthesia. Total time of operation and blood loss during procedure was noted. Results: Our study showed that mean operative time in Harmonic group (A) was 38.07+5.28 minutes and in Conventional group (B) 63.75+7.62 minutes, (p-value = 0.0001), blood loss in Harmonic group (A) 32.93+8.86ml and 55.53+8.96ml in Conventional group (B), (p-value = 0.0001). Conclusion: It is concluded that the laparoscopic cholecystectomy using harmonic scalpel is significantly better when compared with conventional laparoscopic cholecystectomy in patients of symptomatic gallstones in terms of mean operative time and mean intra-operative blood loss.


INTRODUCTION
Formation of stones in the gall bladder is termed as Cholelithiasis. It is one of the common presentations of middle age adult's on the surgical floor. Patients can present with right sub costal pain with nausea, vomiting, postprandial fullness and abdominal discomfort, disturbing the daily routine activities. In developed countries its prevalence is about 15%. 1 Among the nonmodifiable risk factors, Age is on the top. Patients of age 20 to 40 years are mostly affected. 2 Complications include acute cholcystitis, chronic cholecystitis, choledocholithiasis, cholangitis and pancreatitis. The choice of treatment of gall stones is removal of gallbladder (i.e. cholecystectomy). 3 Laparoscopic cholecystectomy has now become common in the management of cholelithiasis with shorter hospital stay and post-operative complications. Traditionally calot's triangle and gall bladder are dissected with monopolar cautery but there is always risk of bleeding, collateral damage, smoke production, compromised vision hence prolonged operative time. 4 In advance techniques, Harmonic scalpel is now used during laparoscopy to prevent these complications. 5 The scalpel enables synchronous cutting, coagulation, and cavitation of the thicker tissue by a high-frequency (55,500 Hz) vibration, which generates heat by tissue stress and friction to degenerate tissue protein. This technique transfers minimal energy to the tissues in proximity and thereby minimizes the risk of collateral thermal damage. In addition, using a Harmonic scalpel can securely close and seal the biliary ducts and vessels with a diameter of ≤5 mm without requiring vessel clipping. 6 As there is controversy in literature regarding the effectiveness of use of harmonic scalpel technique in comparison of conventional technique of laparoscopic cholecystectomy in terms of intraoperative time and blood loss. So the objective of this study was to determine the mean operative time and mean intra-operative blood loss in the two techniques in LC and my study will be helpful in selecting the better treatment modality for symptomatic gallstones.

MATERIAL & METHODS
Randomized control trial at Surgical Department of Allied hospital Faisalabad conducted six months after approval from the hospital ethical review committee. Patient with symptomatic gall stones including both male and female patients age ranges from 20-70 years with duration of symptoms > 6 months and patients having ASA status I and II were included in the study.
Symptomatic Gallstones defined as pain in the upper part of abdomen and radiating to back and right shoulder tip and confirmed on ultrasound if gall bladder showed a hyper-echoic mass with clear acoustic shadow. Operative Time was defined as the time from skin incision to skin approximation measured in minutes. Intra-Operative Blood Loss was defined as estimated by measuring blood aspirated from the operative field. Patients having common bile duct stones, patients with suspicion of gall bladder malignancy, patients having acute cholecystitis and patients with of previous upper abdominal surgery were excluded from the study. Sample size of 80 (40 in each group) calculated using WHO sample size calculator for 2 mean Test value of population mean = 50.17 7 with pooled deviation of 40.58,power of study 90%,level of significance 5% and anticipated population mean of 100.08. 7 After explaining the study to the cases informed consent was taken.
Eighty (80) patients (forty in one group) divided randomly into A (harmonic scalpel group) and B (conventional) group. Total time of operation and blood loss during procedure was noted. All procedures were done under general anesthesia by a consultant having more than 5 years post fellowship experience using 4 ports. In Group A calot's triangle dissected with Harmonic and Maryland forceps, cystic duct & artery separated, clipped and cut with Harmonic Scalpel while same instrument used for dissection of gall bladder from its bed. In Group B Monopolar Cautery and Maryland forceps used to dissect cystic dust and artery. Cystic duct was cut with scissor after clipping & clipped cystic artery was cut with monopolar cautery followed by dissection of gall bladder from it bed with the same instrument. Data collected was noted according to a predesigned proforma.
Data entered and analyzed in SPSS version 20 with mean and standard deviation calculated for quantitative variables (age, duration of disease, operative time and intra-operative blood loss) and frequency with percentage calculated for qualitative variables like gender. Both major outcome variables (operative time and intraoperative blood loss) were compared using independent sample t-test. P-value ≤0.05 was considered significant. Effect modifiers like age, gender and duration of disease were controlled by stratification. Post-stratification independent sample t-test was applied.   We compared our results with a study, where the mean intra-operative blood loss in laparoscopic cholecystectomy using harmonic scalpel was 50.17±35.97 ml and intra-operative blood loss in conventional laparoscopic cholecystectomy 100.08±44.72 ml. Mean operative time for laparoscopic cholecystectomy using harmonic scalpel was 40±4.42 min and operative time for conventional laparoscopic cholecystectomy was 80±17.02 min. 7 Our findings are close to the above study.

Eighty
In another study, mean intra-operative blood loss in laparoscopic cholecystectomy using harmonic scalpel was 14.2±10.6 ml and intraoperative blood loss in conventional laparoscopic cholecystectomy 13.7±9.1 ml. Mean operative time for laparoscopic cholecystectomy using harmonic scalpel was 54.9±13.1 min and operative time for conventional laparoscopic Though there is a significant difference in operative and blood loss in our results and the above study, however, in both studies, it is justified that laparoscopic cholecystectomy is better than conventional.
Another study 8  Considering the results of our study and other above studies, the hypothesis of this trial "laparoscopic cholecystectomy using harmonic scalpel is better than conventional laparoscopic cholecystectomy in patients of symptomatic gallstones in terms of mean operative time and mean intra-operative blood loss" is justified.
This was a single center study and limited local and regional data is available regarding this topic. This study didn't compare other the postoperative complications possible related with the use of harmonic scalpel. Many controlled trials should be done comparing the two techniques in our region and in our country so that complications can be minimized and a better technique should be promoted.

CONCLUSION
We concluded that the laparoscopic cholecystectomy using harmonic scalpel is significantly better when compared with conventional laparoscopic cholecystectomy in patients of symptomatic gallstones in terms of mean operative time and mean intra-operative blood loss.