Energised Dissection (ED) & Patient Reported Outcomes (PRO) Greetings Energised Dissection (ED) & Patient Reported Outcomes (PRO) Prof. (Dr. ) Brij B. Agarwal Vice Chairman, Deptt. Of Laparoscopic & General Surgery, SGRH Chairman, International Medical Sciences Academy, Delhi Secretary, Association of Surgeons of India, Delhi Associate Editor, Indian Journal of Surgery Vice Chairman, International Society of ColoProctology Asia Pacific Member, STARR Expert Group, Hamburg, Germany Asia Pacific Advisor, Society of Laparoscopic Surgeons of America Brij B. Agarwal. SURGICON 2014

Disclosures Based upon studies presented at SAGES from 2007- 2013 and published in Surgical Endoscopy from 2007-Nov 2014 issues. No conflict of interest to declare Brij B. Agarwal. SURGICON 2014

Surgery leaves scars not only on body but on mind as well Scars are a result of inflammation mediated healing process Minimal access surgery has the same physiological invasion Over all physiological healing is dependent upon the surgically induced systemic inflammation Brij B. Agarwal. SURGICON 2014

What is Energised Dissection (ED) ? Using surgical energy to proceed with dissection It can be monopolar or bipolar electrosurgery/Cautery, ultrasonic energy, laser etc. We believe it should be used only for hemostasis & not dissection Brij B. Agarwal. SURGICON 2014

What are Patient Reported Outcomes (PRO) Wound Inflammation/ Healing Related Post-operative pain- Analgesia requirement Post-operative Convalescence Return to normal activity Systemic Inflammatory Response Related Post-operative nausea & vomiting Post-operative fatigue Post-operative circadian/sleep disturbances Brij B. Agarwal. SURGICON 2014

Energised Dissection (ED) & Patient Reported Outcomes (PRO) Our Hypothesis ED adds to inflammatory response to surgery Surgical inflammation can affect PROs Both clinical as well as molecular markers of post-operative inflammatory response are deranged Brij B. Agarwal. SURGICON 2014

Laparoscopic Cholecystectomy as an Index for study LC is an Index laparoscopic surgery LC is an index of training in laparoscopic surgery LC is an index of social perception of laparoscopic surgery LC is an index of surgical outcomes in laparoscopic surgery LC is an index of adverse outcomes in laparoscopic surgery & litigation Laparoscopic Cholecystectomy (LC) is universally done using ED Hence LC was an ideal surgery to study the effects of ED on PROs Brij B. Agarwal. SURGICON 2014

Pursuit of our Hypothesis Feasibilty study Anatomical basis of surgical navigation Reproducibility by all consultants in a surgical unit Reproducibility by senior residents Reproducible by supervised junior residents across units 10 years consecutive experience Case control study Present study moving towards RCT So we are moving from Level 4 to Level 1 designs Brij B. Agarwal. SURGICON 2014

Cystic Artery is an end Artery Brij B. Agarwal. SURGICON 2014

Brij B. Agarwal. SURGICON 2014

There are no blood vessels between GB & Liver Brij B. Agarwal. SURGICON 2014

All consenting consecutive candidates for LC were enrolled for the study Inclusion criteria 1) Able to understand and sign an informed consent 2) Literate enough and willing to communicate adverse events during the 90-day follow-up period Exclusion criteria 1) Presence of co-morbidity, precluding the patient‘s fitness for general anesthesia (GA) following failed preoperative optimization of co-morbidities 2) Pregnancy Brij B. Agarwal. SURGICON 2014

Study Design & Study Flow Brij B. Agarwal. SURGICON 2014

Study Points and Observer Stage of study Study points Observer Perioperative Technical difficulty; Hemodynamic instability; Conversion to open surgery; Blood transfusion (BT); Injury to Common Bile Duct (CBD)/hollow viscera Independent anaesthesist Postoperative Peritonism for >24 hr (paralytic ileus); Shoulder-tip pain for >24 hrs; Biliary leak; Re-intervention Independent non operating member Other data Length of hospital stay (LOS); Resumption of normal activity within 5 days; Any adverse event in 3 months; Mortality From Hospital Information System (HIS) and PRO Brij B. Agarwal. SURGICON 2014

Results Brij B. Agarwal. SURGICON 2014

Demographics & Co-morbidities Status Energised Dissection (ED)-Control : Cold Dissection (CD)- Study Variable ED (n=361) CD (n=384) p- Value Age, mean (SD) years   44.4 (14.4) 46.4 (13.4) 0.04 Male = n (%) Female = n (%) 100 (27.7) 261 (72.3) 122(31.8) 262(68.2) 0.22 Co-morbidity = n (%): Diabetes Hypertension No DM / HTN 80 (22.1) 29 (8) 252 (69) 96 (25) 29 (7.5) 254 (67.4) 0.65 Pre –operative ERCP, n (%) 35 (9.7) 42(10.9) 0.225 Brij B. Agarwal. SURGICON 2014

Gallbladder Inflammation Status Variable: Grade of inflammation, n (%) ED (n=361) CD (n=384) p- Value Chronic cholecystitis Acute cholecystitis Mucocele Gangrenous\Perfora ted 296 (82) 26 (7.2) 31 (8.6) 8 (2.2) 299 (77.9) 36 (9.4) 38 (9.9) 11 (2.9) 0.55 Brij B. Agarwal. SURGICON 2014 Brij B. Agarwal. SURGICON 2014

Postoperative outcomes according to Clavien-Dindo Grade Observation Grade ED (n=361) CD (n=384) p-Value CBD Injury III 1 <0.009 Conversion Blood Transfusion at Index Admission II 2 Postoperative Biliary Leak Re-intervention at Index Admission Required ICU Management IV 3 Re-hospitalization III-IV Mortality V Length of Stay in Hospital (days) I 1.6+1.03 1.35+1.2 <0.001 Dindo D et al.(2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213 Brij B. Agarwal. SURGICON 2014

Our Unambiguous observations Higher grade of complications are more likely with ED in LC Brij B. Agarwal. SURGICON 2014

Then we studied the Molecular response All the inflammatory markers i.e. IL6, HSCRP, TNF were significantly raise in ED group & their return to baseline was much longer ( Post-op fatifue/ panalgesia requirement, sleep disturbance) Similar rise & delayed molecular response was seen in LFT These were associated with higher degrees & incidence of post-operative nausea & vomitting Brij B. Agarwal. SURGICON 2014

Take Home Message ED should be jused judiciously & kept to minimum ED should remain an hemostatic tool ED has no scientific validity to be used for dissection We have been invited for a podium Presentation at SAGES 2015,for the molecular effects Study Brij B. Agarwal. SURGICON 2014

Thank you Thank you for your kind attention, any questions please Brij B. Agarwal Vice Chairman, Deptt. Of Laparoscopic & General Surgery, Ganga Ram Hospital, Dilli endosurgeon@gmail.com www.endosurgeon.org www.facebook.com/brij.agarwal +91-9810124256 Brij B. Agarwal. SURGICON 2014