Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery- Results of a triple blind randomized study.

Brij B Agarwal, MD1, Juhil D Nanavati, MBBS1, Nayan Agarwal2, Kumar Manish, DNB1, Naveen Sharma, MD2. 1Ganga Ram Institute of Postgraduate Medical Education & Research and Sir Ganga Ram Hospital, India, 2University College of Medical Sciences, University of Delhi, India

INTRODUCTION- We have earlier reported the energized disection (ED) induced addition to the surgical inflammatory response. This study is evaluating the quantitative biomolecular inflammatory changes due to ED in laparoscopic surgery (LS)

METHODS AND PROCEDURES -An open ended triple blind randomized study of consecutive unselected consenting candidates for day care Laparoscopic Cholecystectomy (LC), an index LS

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Biochemical Markers Studied; Starting at 1st Incision i.e. 0 Hour (H)
Marker Molecule Time
Cytokines IL-6, HS-CRP, TNF-∝ H0, H4, H24
LiverEnzyme SGOT,SGPT,ALP,GGT H0, H4, H24

Randomization by external research coordinators ( blind to peri-operative observations) into Group A and Group B. Standard techniques of LC with or without ED being followed by operating surgeons (blind to pre & postoperative parameters / observations) for the group allocated. Energy sources were/ are available as 'stand by' / rescue.The data is being collected by non-operative research coordinators (blind to operative technique) & stored in online auto-locking ( <24 Hrs) Hospital Information System (HIS). Prospectively collected data will be analyzed at the completion of the study according to the randomization code provided to the investigators (blind to peri-operative care).

Result : Demographics
Parameter Group A Group B
% Males 28.57 40
% Females 71.43 60
Age Average (Yrs) 42.38 43.9
BMI 23.29 24.63
%DiabetesMellitus 13 25
% Hypertension 6 20
ASA (Average Grade) 1.27 1.6
Results: ; Mean (Range) (Group A, n=51 Group B, n=47) at H0,H4 &H24
Molecule Group A Group B
IL-6 (pg/mL) 3.09 (0.38-10.43), 33.64 (3.5-202.63), 35.67 (5.4-291.57) 5.07 (1.55-29.77), 12.09 (4.4-22.57), 26.4 (4.08-29.9)
HS-CRP (mg/dL) 0.18 (0.01-0.66), 0.42 (0.08-1.62), 4.24 (0.24-16.47) 1.81 (0.02-16.07), 1.90 (0.03-16.1), 4.14 (0.6-13.76)
TNF-∝ (pg/mL) 8.39 (2.1-12.6), 12.84 (7.0-39.1), 15.32 (9.1-61.9) 11.62 (1.95-18.8), 14.27 (9.3-25.1), 15.11 (9.7-22.6)
SGOT 24.44 (13-44), 69.13 (27-428), 42.56 (21-101) 20.80 (15-35), 52.1 (23-78), 36.2 (19-56)
SGPT 30.25 (10-154), 49.75 (21-85), 46 (32-71) 17.60 (9-38), 43.90 (14-67), 38.20 (14-53)
ALP 81 (50-314), 79.44 (51-249), 79.06 (60-241) 76.10 (40-131), 83.60 (44-125), 82.50 (43-124)
GGT 34.31 (9-253), 32.63 (13-180), 32.31 (24-174) 14.80 (8-21), 19.50 (14-34), 20.30 (11-38)

The comprehensive HIS data & randomization codes will be available to the investigators in January 2015.The results from January2014- December 2014 will be presented.

Coclusions: Appropriately analyzed results will be presented & discussed at the meeting

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