Brij B Agarwal, MD1, Juhil D Nanavati, MBBS1, Nayan Agarwal, MBBSS2, 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 patient reported outcomes (PRO) related benefits of Yoga practice (YP) in laparoscopic surgery (LS) in a non-randomized study. We undertook a prospective blinded study for impact of YP on outcomes with laparoscopic cholecystectomy(LC) as an index LS.
METHODS AND PROCEDURES -An open ended triple blind randomized study of consecutive unselected consenting candidates for elective LC. Randomization by external research coordinators ( blind to peri-operative observations) into Group A and Group B. Standard techniques of LC followed by operating surgeons (blind to pre & postoperative parameters / observations).
| Post Operative (PO) PROs | Scale Used | Day (D)/week(W)/Month(M) |
Pain(POP) | 100point VAS | D1,D3,D10,W3 |
| Nausea & vomiting (PONV) | 6 point PONV | D1,D3,D10,W3 |
| Fatigue (POF) | 84 point MFIS | D1,D3,D10,W3 |
| Quality of Sleep(QoS) | 21point Pittsburg | W3 |
| GIQoL | 144 point GIQoL | M3 |
| Activity Resumed(AR) | Days | D |
| Marker | Molecule | Time |
| Cytokines | IL-6, HS-CRP, TNF-∝ | H0, H4, H24 |
| LiverEnzyme | SGOT,SGPT,ALP,GGT | H0, H4, H24 |
| Study Point | Group A | Group B |
| POP | 35.47 (10-86), 23.80 (6-79), 14.13 (4-75), 6.40 (2-32) | 34.53 (20-50), 19.62 (12-33), 9.08 (6-14), 3.62 (2-7) |
| PONV | 0.53 (0-3), 0.27 (0-2), 0.13 (0-2), 0.00 (0-0) | 0.31 (0-1), 0.08 (0-1), 0.0 (0-0), 0.0 (0-0) |
| MFIS | 26.87 (16-62), 18.33 (10-56), 11.90 (4-44), 5.00 (2-12) | 24.31 (13-45), 16.92 (10-42), 8.77 (5-16), 4.23 (2-10) |
| PSS | 10.33 (7-17) | 7.23 (2-13) |
| GiQoL | 23.53 (14-40) | 17.31 (12-26) |
| AR | 7.27 (3-36) | 5.08 (3-7) |
| IL-6 (pg/mL) | 6.32 (1.55-9.77), 31.26 (4.68-202.63), 51.58 (4.08-291.57) | 2.46 (0.38-3.4), 11.42 (3.5-31.06), 13.5 (2.1-38.3) |
| HS-CRP (mg/dL) | 1.63 (0.02-16.07), 1.85 (0.03-16.1), 5.66 (0.6-16.47) | 0.20 (0.01-0.66), 0.35 (0.04-1.62), 3.13 (0.44-14.47) |
| TNF-∝ (pg/mL) | 11.02 (7.7-18.8), 16.10 (8.9-39.1), 19.01 (9.1-61.9) | 8.62 (1.66-15.8), 11.41 (7-17.2), 12.48 (9.2-15.2) |
| SGOT | 21.09 (14-44), 52.09 (27-78), 43.18 (30-79) | 24.47 (13-37), 70.27 (23-428), 37.87 (19-101) |
| SGPT | 28.45 (9-154), 47.18 (21-85), 44.55 (25-71) | 23.13 (12-43), 47.73 (14-167), 41.87 (14-130) |
| ALP | 85.55 (40-314), 88.18 (44-249), 88.18 (43-241) | 74.40 (28-131), 75.80 (28-125), 74.67 (28-124) |
| GGT | 35.82 (9-253), 33.64 (13-180), (35.82 (10-174) | 20.20 (5-101), 23.13 (5-83), 21.73 (8-81) |
Prospective data being collected online auto-locking Hospital Information System.
Conclusions: The codes will be broken at study completion(Jan2014-Dec2014) & the appropriately analyzed results will be presented & discussed