Brij B Agarwal, MD1, Juhil D Nanavati, MBBS1, Nayan Agarwal2, Naveen Sharma, MD2. 1Ganga Ram Institute of Postgraduate Medical Education and Research &Sir Ganga Ram Hospital, India., 2University College of Medical College, University of Delhi, India
INTRODUCTION- We have earlier reported non-inferiority & potential patient reported outcomes (PRO) related benefits of avoiding energized dissection (ED) in laparoscopic cholecystectomy (LC). We undertook a better designed study to evalute the impact of ED on the PROs following LC.
METHODS AND PROCEDURES -An open ended triple blind randomized study of consecutive unselected consenting candidates for day care LC. Randomization by external research coordinators ( blind to peri-operative observations) into Group A and Group B. Standard techniques of LC with ED or CD followed by operating surgeons (blind to pre & postoperative parameters / observations) for the group allocated. Energy sources were/ are available as 'stand by' / rescue.
Post Operative (PO) PROs
|Pain (POP)||100 point VAS||D1,D3,D10,W3|
|Nausea & vomiting (PONV)||6 point PONV||
|Fatigue (POF)||84 point MFIS||D1,D3,D10,W3|
|Quality of Sleep(QoS)||21-point Pittsburg||W3|
|GIQoL||144 point GIQoL||M3|
|Peri-operative||Technical difficulty, Hemodynamic instability, Conversion, Blood transfusion, Injury Bile Duct/ hollow viscera|
|Post-operative||Peritonism for >24 hr; shoulder tip pain for >24 hrs; biliary leak; re-intervention; re-hospitalization for any complication|
|Other & PROs||Length of hospital stay, Self-care ability after 1 day, Resumption of normal activity as per preop patient defined activity, any adverse event in 3 months, mortality|
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).
|Study Point||Group A (n= 71)||Group B (n= 63)|
|VAS (D1, D3, D10, W3)||39.72 (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)|
|PONV (D1, D3, D10, W3)||0.5 (0-3), 0.28 (0-2), 0.11 (0-2), 0||0.3 (0-1), 0, 0, 0|
|MFIS (D1, D3, D10, W3)||28.83 (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)|
|PSS (Sleep) (W3)||9.56 (2-17)||7.7 (5-11)|
|GIQoL (M3)||23.5 (12-40)||15.5 (12-20)|
|Return to Normal Activity-days||7.95 (3-36)||4.6 (3-7)|
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- This is a better designed study to evaluate our earlier reported benefits of avoiding ED in LC.