Objective of Study
Post-operative pain, fatigue, circadian disturbances & well-being are cardinal patient reported outcome (PRO) measures indicating desired/ expected Health related Quality of Life (HrQoL) improvement after Laparoscopic Cholecystectomy (LC). These PROs result from a cascade of inflammatory and metabolic stress responses to surgery. Energised dissection (ED) in LC may excite these inflammatory & stress pathways as ED isn’t physiologically inert. We studied the effect of ED on PROs after LC.
Methods and procedures
Consecutive unselected candidates for day care LC (March 2007-Feb 2009) were enrolled following Ethics/ Informed Consent Protocol to be allocated to Study group i.e. LC without ED (LC-ED; those consulting us in the morning clinic) and the Control Group i.e. LC with ED (LC+ED; those consulting us in the evening clinic). A standard anesthesia / antibiotic/ analgesia / surgery & discharge protocol was followed.
|Study End Point||Measuring Scale|
|HrQoL||100-point; 36-items;8-subscale SF-36 generic measure|
|Nausea||0-no nausea; 1-some; 2-moderate; 3-severe; 4-vomiting|
|Pain||no pain-worst @100 point visual analog scale (VAS)|
|Sleep Quality||worst – best sleep @ 0-100-mm VAS-assessed at 8am.|
|Well Being||100-mm VAS-assessed in evening at 8pm.|
|Discharge Willingness||4 point Likert scale i.e.1-donot want to go; 2-will go if all is definitely well; 3-will go if doctor insists; 4-want to go|
|Fatigue||10-point Christensen fatigue scale; 1 = fit, 10 = fatigued|
Prospective data collected pre-operatively (P0) & post-operatively on Day1 (D1), Day2 (D2), Day3 (D3), 1st week (W1), 2nd week (W2) & 3rd week (W3).
The Study (53) & Control (93) groups were well matched for demographic, activity, co-morbidity and gallbladder inflammation parameters. There were no adverse events or failure to discharge from day care although control group patients were extremely reluctant. Patient noncompliance led to withdrawal of 9 & 17 patients leaving 44 (study) & 76 (control) for analysis. Only patients of LC+ED reported right sided scapulo-costal & shoulder tip pain predominating up to D3, patients of LC-ED didn’t report this at all.
|Sleep Quality||General Well-Being|
*PF-physical functioning; RP-role physical; BP-bodily pain; GHP-general health perception; VI-vitality; SF-social functioning; RE-role emotional; MH-mental health
Patient reported outcomes are better after laparoscopic cholecystectomy without energized dissection benefitting the global sense of well being.
Program Number: P421