Effect of surgical energy usage on clinical pathway of laparoscopic cholecystectomy :Results of a triple blind randomized study

Brij B Agarwal, MS1, Juhil D Nanavati, MBBS1, Nayan Agarwal, MBBS, S2, Kumar Manish, DNB1, Satish Saluja, MD1, Naveen Sharma, MS2. 1Ganga Ram Institute of Postgraduate Medical Education & Research and Sir Ganga Ram Hospital India, 2University College of Medical Sciences, University of Delhi, India

Introduction:Elective Laparoscopic Cholecystectomy (LC) is an ambulatory or day care surgery. Postoperative morbidity can prolong hospitalisation upsetting the fasttrack clinical pathways.We studied the impact of using surgical energy (USE) in LC on existing fasttrack LC clinical pathway protocols.

METHODS AND PROCEDURES -An open ended triple blind randomized study of consecutive unselected consenting LC candidates for standard ambulatory (discharge ability < 4hours) clinical pathway protocol. Randomization by external research coordinators ( blind to peri-operative observations) into Group A and Group B. Standard techniques of LC with / without USE followed by surgeons (blind to pre-postoperative parameters / observations) for the group allocated. The data being collected by blinded non-operative research coordinators & stored online in auto-locking Hospital Information System (HIS). Prospective data will be analyzed at completion.

Clinical Pathway related data- Group A (n=121) Group B (n=116)

Study PointGroup AGroup B

Operating time-Average (mins)


Iatrogenic Gallbladder(GB) Perforation [IGbP] (%)

By dissecting instrument % of IGbP

By Grasping instrument % of IGbP







GB bed surface hemostatic aid used-%33.0546.55
Index Bile duct Injury %0.80
Significant ShoulderTipPain > 24Hrs- %66.6719.82
Peritonism > 24 Hrs.- %27.785.48

Postoperative Mean hospitalisation _Hours

(excludes duct injury& rehospitalisation)

Metrics used for post-operative clinical outcomes
Pain (POP)100pointVASD1, D3, D10, W3
Nause-Vomit(PONV)6point PONVD1, D3, D10, W3
Fatigue(POF)84point MIFSD1, D3, D10, W3
Sleep Quality(QoL)21point PSSW3
GIQoL144point GIQoLM3
Results: Outcomes- Group A (n=121) Group B (n=116)
Group AGroup B
POP39.72 (20-86), 25.66 (11-79), 14.11 (5-75), 6 (2-32)26.6 (10-40), 15 (6-26), 7.6 (4-14), 3.5 (2-7)
PONV0.5 (0-3), 0.28 (0-2), 0.11 (0-2), 00.3 (0-1), 0 (0-0), 0 (0-0), 0
MIFS28.83 (16-62), 19.94 (10-56), 12.30 (5-44), 5.5 (3-12)20 (13-32), 13.6 (10-22), 7 (4-10), 3.1 (2-7)
PSS9.56 (2-17)7.7 (5-11)
GIQoL23.5 (12-40)15.5 (12-20)
AR7.95 (3-36)4.6 (3-7)

The HIS data & randomization codes will be available to the blinded 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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