1. 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

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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

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

10. Brij B. Agarwal. SURGICON 2014

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

12. 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

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

14. 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

15. Results
Brij B. Agarwal. SURGICON 2014

16. 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

17. 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

18. 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
<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

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

20. 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

21. 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

22. 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
Brij B. Agarwal. SURGICON 2014