1. Single Site Umbilical Laparoscopic Surgery (SSULS) George W. Holcomb, III, M.D., MBA Surgeon-in-Chief Children’s Mercy Hospital Kansas City, MO

2. Open Surgery Laparoscopic Surgery 1)Less discomfort 2)Reduced hospitalization 3)Faster return to routine activities 4)Cosmesis

3. SSULS Cosmesis, but less risky c/w NOTES Open SurgeryLaparoscopic Surgery NOTES Cosmesis, but risks

4. SILS (TM) -Single Incision Laparoscopic Surgery SPA (TM) -Single Port Access SSULS -Single Site Umbilical Laparoscopic Surgery (CMH) SIPES –Single Incision Pediatric Endosurgery (CH-A) All use umbilicus as single site. Acronyms

5. Umbilical Portals (U.S.) SILS Port (Covidien) Tri - Port (Olympus)

6. Umbilical Portals (U.S.)

7. What Else Is Different? Instruments are in-line and parallel to each other Ideally, instruments/telescope should be different lengths

8. What Else Is Different? Assistant/camera holder stands next to or behind the surgeon

9. What Else Is Different? Harder to operate

10. What Operations Are Being Done Using This SSULS Approach? Appendectomy Cholecystectomy Splenectomy Ileocecectomy Pyloromyotomy (CH-A) Fundoplication (CH-A) Others

11. SSULS Appendectomy

13. Please use this link if you experience problems viewing the video above.this link

14. Postoperative Appearance

15. SSULS Cholecystectomy Please use this link if you experience problems viewing the video above.this link

16. SSULS Splenectomy Please use this link if you experience problems viewing the video above.this link

17. SSULS Splenectomy

18. SSULS Ileocecectomy Intracorporeal dissection/mobilization Extracorporeal resection/anastomosis

19. Single-Incision Laparoscopic Surgery in Children: Initial Single-Center Experience 142 SSULS procedures: Appendectomy (103) Cholecystectomy (24) Splenectomy (2) Cholecystectomy/splenectomy (1) Ileocecectomy (8) J Pediatr Surg 46:904-907, 2011

20. Results Procedure Additional ports Mean Op time (min) Mean LOS (days) Complications Appendectomy (103) 1034+/-1616 Cholecystectomy (24) 273+/-281.50 Splenectomy (2) 090+/- 61.50 Cholecystectomy /splenectomy (1) 011610 Ileocecectomy (8) 086+/-2250 J Pediatr Surg 46:904-907, 2011

21. SIPES CH - ALABAMA Appendectomy -130 Pyloromyotomy -32 Cholecystectomy -32 Fundoplication -6 Pull-through -4 204 Pediatr Surg Int 2010

22. Conclusion These series show that single site surgery is feasible, and appears to be associated with acceptable operating times

23. Disadvantages Compromised degrees of freedom and triangulation Visualization limited by inline field of view and motion of instruments More difficult for the surgeon

24. Questions Do the benefits outweigh the risks? What are the benefits? Is there improved cosmesis? Prospective evidence needed We are enrolling in 3 SSULS PRT’s  Appendectomy, Cholecystectomy, Splenectomy  Validated scar assessment tool

25. Prospective Randomized Trials Power1 0 Outcome AnalysisVariable SSULS Appendectomy360 (360)Infection SSULS Cholecystectomy 60 (60)Operative time SSULS Splenectomy30 ( 7)Operative time

26. Other Variables Being Collected Pain Cost (hospital charges) Cosmesis (Validated Scar Assessment Tool)

27. Aug 2009 – Nov 2010 Non-perforated appendicitis 360 pts – 180 each arm No difference in patient characteristics at time of operation

28. Ann Surg 254: 586-590, 2011 SSULS vs 3-Port Lap. Appendectomy Single Incision (N=180) 3-Port (N=180)P Age (yrs) 11.1 +/- 3.511.1 +/- 3.30.90 Weight (kg)42.7 +/- 18.542.5 +/- 17.40.90 Body mass index (kg/m 2 )19.4 +/- 4.919.6 +/- 4.50.67 Gender (% male)55.0%51.1%0.53 Admission temperature ( o C) 37.1 +/- 0.737.0 +/- 0.70.46 Leukocyte count (1000 cells/mm 3 ) 14.6 +/- 5.414.6 +/- 5.20.96 Table 1- Patient Characteristics at Operation

29. SSULS vs 3-Port Lap. Appendectomy Table 2 - Operative Data Single Incision (N=180) 3-Port (N=180) P Operative Time (mins) 35.2 +/- 14.529.8 +/- 11.6<0.001 Surgical Difficulty (1–Easy to 5–Difficult) 2.3 +/- 1.41.7 +/- 1.0<0.001 Ann Surg 254: 586-590, 2011

30. SSULS vs 3-Port Lap. Appendectomy Single Incision (N=180) 3-Port (N=180) P Wound Infection 3.3%1.7%0.50 Abscess 0.0%0.6%0.99 Time to Liquid Diet (Hours) 4.1 +/- 3.73.7 +/- 3.10.25 Time to Regular Diet (Hours) 7.2 +/- 5.16.9 +/- 5.20.48 Postoperative Length of Stay (hours) 22.7 +/- 6.222.2 +/- 6.80.44 Total Doses of Analgesics 9.6 +/- 4.98.5 +/- 4.30.04 Hospital Charges ($) 17.6K +/- 4.0K16.6K +/- 3.9K0.005 Corrected Charges* ($) 16.8K +/- 4.1K16.6K +/- 3.9K0.60 Table 3 - Table 3 - Outcome Data *Hospital charges minus the stapler charges. Ann Surg 254: 586-590, 2011

31. SSULS vs 3-Port Lap. Appendectomy Single Incision (104) 3-Port (101) P Days of Prescribed Analgesics 3.8 +/- 3.64.0 +/- 5.10.85 Doses of Prescribed Analgesics 6.4 +/- 9.35.1 +/- 6.60.37 Days to Full Activity 7.5 +/- 5.88.5 +/- 6.20.33 Days to Return to School 4.7 +/- 2.94.9 +/- 3.70.77 Table 4 - Convalescence After Hospital Discharge

32. Summary No difference in infectious complications: wound infx, intra-abd abscess mean operating time for SSULS – 5 min ? clinical relevance (but leads to hospital charges) doses analgesics (p =.04) for SSULS Cosmetic advantage for SSULS – We’ll see. Ann Surg 254:586-590, 2011

33. Does Body Habitus Make a Difference? SINGLE SITE Normal (N=135) Overweight (N=26) P-Value Obese (N=19) P-Value Age (yrs)11.0 ± 3.510.8 ± 3.90.7812.1 ± 2.90.20 Weight (kg)38.3 ± 14.547.4 ± 19.1N/A67.5 ± 22.0N/A Body Mass Index Percentile 41.1 ± 26.489.7 ± 2.8N/A97.5 ± 1.5N/A Gender (% male)53.357.70.8363.20.47 3 PORT Normal (N=139) Overweight (N=25) P-Value Obese (N=16) P-Value Age (yrs)10.9 ± 3.411.9 ± 2.70.1711.7 ± 3.50.38 Weight (kg)37.8 ± 14.152.7 ± 15.3N/A66.8 ± 20.5N/A Body Mass Index Percentile 44.7 ± 26.589.6 ± 2.5N/A97.1 ± 1.7N/A Gender (% male)50.460.00.4043.80.79 IPEG 2012

34. Outcomes for 3-Port Based on Body Habitus 3 PORT Normal (N=139) Overweight (N=25) P-Value Obese (N=16) P-Value Operating Time (Minutes)29.6 ± 13.631.4 ±12.60.4729.3 ± 20.10.93 Surgical Difficulty (1 – Easy to 5 – Difficult) 1.7 ± 1.01.6 ± 1.00.701.5 ± 0.60.33 Wound Infection (%)2.201.000 Doses of Narcotics5.3 ± 3.24.6 ± 3.20.316.2 ± 4.40.32 LOS after Operation (Hours) 22.5 ± 7.220.6 ± 5.00.2221.8 ± 5.40.72 Hospital Charges ($)16.4K ± 4.0K17.2K ± 2.9K0.3217.1K ± 4.1K0.51 IPEG 2012

35. Outcomes for Single Incision Based on Body Habitus SINGLE SITE Normal (N=135) Overweight (N=26) P-ValueObese (N=19)P-Value Operating Time (Minutes) 34.0 ± 13.634.1 ± 11.90.9745.4 ± 20.10.002 Surgical Difficulty (1 – Easy to 5 – Difficult) 2.2 ± 1.42.6 ± 1.40.182.5 ± 1.40.38 Wound Infection (%)1.57.70.1210.50.08 Doses of Narcotics5.7 ± 3.55.6 ± 3.70.857.6 ± 0.150.05 LOS after Operation (Hours) 22.0 ± 5.724.1 ± 6.70.1125.4 ± 8.10.03 Hospital Charges ($)17.1K ± 3.8K18.5K ± 3.9K0.0920.3K ± 4.7K< 0.001 IPEG 2012

36. Outcome Comparison for Normal Weight NORMALSINGLE (N=135)3 PORT (N=139)P-Value Operating Time (Minutes) 34.0 ± 13.629.6 ± 13.6 0.004 Surgical Difficulty (1 – Easy to 5 – Difficult) 2.2 ± 1.41.7 ± 1.0 0.002 Wound Infection (%)1.52.20.68 Doses of Narcotics 5.7 ± 3.55.3 ± 3.2 0.31 LOS after Operation (Hours) 22.0 ± 5.722.5 ± 7.2 0.59 Hospital Charges ($)17.1K ± 3.8K16.4K ± 4.0K0.13 IPEG 2012

37. OVERWEIGHT SINGLE (N=26)3 PORT (N=25) P-Value Operating Time (Minutes) 34.1 ± 11.931.4 ±12.6 0.44 Surgical Difficulty (1 – Easy to 5 – Difficult) 2.6 ± 1.41.6 ± 1.0 0.006 Wound Infection (%) 7.70 0.08 Doses of Narcotics 5.6 ± 3.74.6 ± 3.2 0.32 LOS after Operation (Hours) 24.1 ± 6.720.6 ± 5.0 0.04 Hospital Charges ($)18.5K ± 3.9K17.2K ± 2.9K0.20 Outcome Comparison for Overweight IPEG 2012

38. OBESE SINGLE (N=19)3 PORT (N=16) P-Value Operating Time (Minutes) 45.4 ± 20.129.3 ± 20.1 0.006 Surgical Difficulty (1 – Easy to 5 – Difficult) 2.5 ± 1.41.5 ± 0.6 0.014 Wound Infection (%) 10.50 0.11 Doses of Narcotics 7.6 ± 0.156.2 ± 4.4 0.42 LOS after Operation (Hours) 25.4 ± 8.121.8 ± 5.4 0.14 Hospital Charges ($)20.3K ± 4.7K17.1K ± 4.1K0.04 Outcome Comparison for Obese IPEG 2012

39. Conclusions Obesity increases operating time, postoperative length of stay, doses of narcotics, and hospital charges c/w single site lap appendectomy Obesity has no impact in 3 port appendectomy Clinically significant increase in wound infection in overweight and obese patient undergoing single site lap appendectomy We do not recommend single site laparoscopic appendectomy in obese patients IPEG 2012

40. SSULS vs 4-Port Lap. Cholecystectomy Table 1 – Patient Characteristics at Operation APSA 2012 Single Incision (N=30) 4-Port (N=30) P-Value Age (yrs) 14.0 +/- 3.213.3 +/- 3.30.39 Weight (kg)55.0 +/- 19.459.7 +/- 24.00.40 Gender (% male)20% 0.99 Gallstones (% present) 50%56.7%0.7

41. SSULS vs 4-Port Lap. Cholecystectomy Single Incision (N=30) 4-Port (N=30) P-Value Time to Initial Diet (Hours)3.8 +/- 4.75.2 +/- 9.20.41 Time to Full Diet (Hours)6.3 +/- 5.87.2 +/- 9.70.66 Postoperative Length of Stay (days) 1.01 +/- 0.540.90 +/- 0.120.28 Total Doses of Analgesics16.4 +/- 17.810.1 +/- 4.30.06 Hospital Charges ($)29.7K +/- 27.3K20.6K +/- 6.9K0.08 Table 2 – Operative Data Table 3 – Outcome Data APSA 2012 Single Incision (N=30) 4-Port (N=30) P-Value Operative Time (mins)68.6 +/- 22.156.1 +/- 22.10.03 Surgical Difficulty (1 – Easy to 5 – Difficult) 2.7 +/- 1.01.9 +/- 0.80.005

42. SSULS vs 4-Port Lap. Cholecystectomy Single Incision3-Port P-Value Days of Prescribed Analgesics 3.5 +/- 3.23.6 +/- 3.80.96 Doses of Prescribed Analgesics 7.0 +/- 5.93.0 +/- 2.50.23 Days to Full Activity 6.1 +/- 3.16.0 +/- 4.70.96 Days to Return to School 4.8 +/- 1.94.5 +/- 4.20.88 Table 4 – Convalescence After Discharge APSA 2012

43. www.cmhclinicaltrials.com www.cmhmis.com QUESTIONS