title: Outcomes of laparoscopic cholecystectomy done with surgical energy versus done without surgical energy: a prospective-randomized control study.
abstract: OBJECTIVE
  Laparoscopic cholecystectomy (LC), a gold standard procedure can be done without energized dissection (ED). We did a randomized study for the outcomes of LC done with ED or without ED, i.e., with cold dissection (CD).
  
  
  METHODS
  At a tertiary level institution, open-ended prospective-randomized control study was conducted between September 2008 and June 2013. Consecutive, unselected, consenting candidates for LC were enrolled following standard ethics, informed consent, anesthesia, and clinical pathway protocol. They were allocated to control group (LC with ED) or study group (LC with CD, as per our published technique with the option for rescue ED). The study points were based upon Clavien-Dindo grading of postoperative complications. They were either, peri-operative events potentially affecting, hospital stay (Grade I) or Grade II-V, e.g., peri-operative hemodynamic instability, needing intervention/blood transfusion, injury to biliary ducts/hollow viscous, postoperative biliary leak, postoperative re-intervention, re-hospitalization, mortality, and any adverse event during a 90-day follow-up period. The data were prospectively collected in an integrated "hospital information system" that could be retrieved only by independent external coordinators.
  
  
  RESULTS
  Demographics, co-morbidities, and gallbladder inflammation profile of the control group (n = 361) and study group (n = 384) were comparable. There was no rescue ED usage in the study group. Hospital stay (Grade I adverse outcome dependent) was longer, i.e., 1.6 ± 1.03 in the control versus 1.35 ± 1.2 days in the study group (p < 0.001). Grade II-IV complications were significantly more (p < 0.009) in control group. There was one common bile duct (CBD) injury in each group. The index bilio-enteric anastomosis for CBD injury in control group failed and needed a revision with multiple interventions. There was one grade V adverse outcome, i.e., mortality in the control group.
  
  
  CONCLUSIONS
  Avoiding the use of ED in LC is associated with better outcomes.
authors.affiliation: Department of General and Laparoscopic Surgery, Ganga Ram Institute of Post Graduate Medical Education and Research (GRIPMER), New Delhi, India, endosurgeon@gmail.com.
authors.forename: Brij B
authors.initials: BB
authors.lastname: Agarwal
authors.forename: Nayan
authors.initials: N
authors.lastname: Agarwal
authors.forename: Krishna A
authors.initials: KA
authors.lastname: Agarwal
authors.forename: Karan
authors.initials: K
authors.lastname: Goyal
authors.forename: Juhil D
authors.initials: JD
authors.lastname: Nanvati
authors.forename: Kumar
authors.initials: K
authors.lastname: Manish
authors.forename: Himanshu
authors.initials: H
authors.lastname: Pandey
authors.forename: Shruti
authors.initials: S
authors.lastname: Sharma
authors.forename: Kamran
authors.initials: K
authors.lastname: Ali
authors.forename: Sheikh T
authors.initials: ST
authors.lastname: Mustafa
authors.forename: Manish K
authors.initials: MK
authors.lastname: Gupta
authors.forename: Satish
authors.initials: S
authors.lastname: Saluja
authors.forename: Sneh
authors.initials: S
authors.lastname: Agarwal
mesh_terms: D017081:Cholecystectomy, Laparoscopic / Q000379:methods*; D002764:Cholecystitis / Q000601:surgery; D003135:Common Bile Duct / Q000293:injuries; D004210:Dissection / Q000379:methods*; D005260:Female; D006801:Humans; D007431:Intraoperative Complications / Q000453:epidemiology; D007902:Length of Stay; D011183:Postoperative Complications / Q000209:etiology; D011184:Postoperative Period; D011446:Prospective Studies; D014464:Ultrasonic Therapy