Effect of Yoga Practice On Laparoscopic Surgery Outcomes: Results of a Randomized Control Study

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).

Metrics for study points

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

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

Results:PROs ; Mean (Range) (Group A, n=52 Group B, n=45)

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