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Comparison of Clinical Outcomes of Laparoscopic Cholecystectomy Done with Surgical Energy Versus Done Without Surgical Energy: A Prospective Randomized Control Study

Brij B Agarwal, MD, Karan Goyal, MBBS, Nayan Agarwal, Krishna A Agarwal, MBBS, M K Gupta, Sheikh M Mustafa, Himanshu Pandey, Satish Saluja, MD. Ganga Ram Institute for Post-Graduate Medical Education & Research, Sir Ganga Ram Hospital, University College of Medical Sciences, Vardhaman Mahavir Medical College & Dr. Agarwal’s Surgery, New Delhi, India.

 INTRODUCTION-This study was undertaken to compare the clinical outcomes of laparoscopic cholecystectomy (LC) done by either using surgical energy i.e. energized dissection (ED) or without using surgical energy i.e. by cold dissection (CD) .

METHODS AND PROCEDURES -A prospective randomized control study (September 2008- June 2013) of consecutive unselected consenting candidates for LC performed on index hospitalization without any exclusion (except uncorrected coagulopathy & unfitness for general anaesthesia). The study population was randomized into ‘Control Group’ (LC with ED) and ‘Study Group’ (LC with CD). A standard perioperative clinical management protocol/ pathway for day care LC was followed. Standard technique of LC for the control group (ED) and our published technique of LC with CD for the study group (CD) were followed. All the LC candidates were operated in same operative complex with same surgical team & same set of instruments. Energy sources were available as ‘stand by’ / rescue for the CD group if needed.

Study Points
Perioperative Technical difficulty, Hemodynamic instability, Conversion, Blood transfusion (BT), Injury to Common Bile Duct(CBD)/ hollow viscera
Postoperative Peritonism for >24 hr (paralytic ileus); shoulder tip pain for >24 hrs; biliary leak; re-intervention; re-hospitalization for any complication
Other data Length of hospital stay (LOS), Self-care ability after 1 day, Resumption of normal activity within 5 days, any adverse event in 3 months, mortality

Prospectively collected data analysed using SPSS-17 version. Qualitative data was compared using chi-square and quantitative data was compared using T-test and P-value < 0.05 was considered significant.

Results-Demographics &; Pre-operative data
Variable ED(n=361) CD(n=384) p- Value
Age, mean (SD) years   44.4 (14.4) 46.4 (13.4) 0.04
Male=  n (%)
Female=n(%)
100 (27.7)
261 (72.3)
122(31.8)    
262(68.2)
0.22
Grade of inflammation, n (%)
Chronic cholecystitis
Acute cholecystitis
Mucocele
Gangrenous\Perforated

296 (82)
26 (7.2)
31 (8.6)
8 (2.2)

299 (77.9)
36 (9.4)
38 (9.9)
11 (2.9

0.55
Comorbidity n (%)
Diabetes
Hypertension
No diabetes/hypertension

80 (22.1)
29 (8)
252 (69)

96 (25)
29 (7.5)
254 (67.4)

0.65
Pre –operative ERCP, n (%) 35 (9.7) 42(10.9)

0.225

 

Results-Post-operative data
Variable ED(n=361) CD(n=384) p-Value
No complications
Complications n (%)
Blood transfusion
Post- operative Bile leak
CBD injury

356 (98.6)
5 (1.4)
2(0.55)
2(0.55)
1(0.27)

383 (99.7)
1 (0.03)
0
0
1(0.03)
0.08
LOS, mean (SD) days 1.6 (1.03) 1.35(1.2) <0.001

There was no technical difficulty in either group & no need of ‘rescue’ use of surgical energy in the CD group. All un-complicated cases could be discharged as ‘day care’. Except for the complications given in the table above,  other adverse study points were not observed in either of the groups.

Coclusion- There was no statistically significant difference in clinical outcomes of LC done either with ED or CD. However occurence of post-operative biliary leaks & hemorrhage necessitating blood transfusion in the ED group(precluding discharge as ‘day care’)  requires further studies to look for any association of adverse outcomes with the use of  ED in LC.

81

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