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

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

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Single Site Umbilical Laparoscopic Surgery

(SSULS)

George W. Holcomb, III, M.D., MBA

Surgeon-in-ChiefChildren’s Mercy Hospital

Kansas City, MO

Open Surgery

Laparoscopic Surgery

1) Less discomfort

2) Reduced hospitalization

3) Faster return to routine activities

4) Cosmesis

SSULS

Cosmesis, but less risky c/w

NOTES

Open Surgery Laparoscopic Surgery

NOTES

• Cosmesis, but risks

• 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

Umbilical Portals (U.S.)

SILS Port(Covidien)

Tri - Port(Olympus)

Umbilical Portals (U.S.)

What Else Is Different?

Instruments are in-line and parallel to each other

Ideally, instruments/telescope should be different lengths

What Else Is Different?

Assistant/camera holder stands next to or behind the surgeon

What Else Is Different?Harder to operate

What Operations Are Being Done Using This SSULS Approach?

• Appendectomy

• Cholecystectomy

• Splenectomy

• Ileocecectomy

• Pyloromyotomy (CH-A)

• Fundoplication (CH-A)

• Others

SSULS Appendectomy

SSULS Appendectomy

SSULS Appendectomy

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Postoperative Appearance

SSULS Cholecystectomy

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SSULS Splenectomy

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SSULS Splenectomy

SSULS Ileocecectomy

•Intracorporeal dissection/mobilization

•Extracorporeal resection/anastomosis

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, 2011J Pediatr Surg 46:904-907, 2011

ResultsResults

ProcedureProcedure Additional Additional portsports

Mean Op Mean Op time (min)time (min)

Mean LOS Mean LOS (days)(days)

ComplicationsComplications

Appendectomy (103) 10 34+/-16 1 6

Cholecystectomy (24)

2 73+/-28 1.5 0

Splenectomy

(2)0 90+/- 6 1.5 0

Cholecystectomy/splenectomy

(1)0 116 1 0

Ileocecectomy (8) 0 86+/-22 5 0

J Pediatr Surg 46:904-907, 2011J Pediatr Surg 46:904-907, 2011

SIPESCH - ALABAMA

Appendectomy - 130

Pyloromyotomy - 32

Cholecystectomy - 32

Fundoplication - 6

Pull-through - 4

204

Pediatr Surg Int 2010Pediatr Surg Int 2010

Conclusion

These series show that single site surgery is

feasible, and appears to be associated

with acceptable operating times

Disadvantages

• Compromised degrees of freedom and triangulation

• Visualization limited by inline field of view and motion of instruments

• More difficult for the surgeon

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

Prospective Randomized Trials

Power 10 Outcome Analysis Variable

SSULS Appendectomy 360 (360) Infection

SSULS Cholecystectomy 60 (60) Operative time

SSULS Splenectomy 30 ( 7) Operative time

Other Variables Being Collected

• Pain

• Cost (hospital charges)

• Cosmesis (Validated Scar Assessment Tool)

• Aug 2009 – Nov 2010

• Non-perforated appendicitis

• 360 pts – 180 each arm

• No difference in patient characteristics at time of operation

Ann Surg 254: 586-590, 2011Ann Surg 254: 586-590, 2011

SSULS vs 3-Port Lap.Appendectomy

  Single Incision   (N=180)    

3-Port (N=180)

PP

Age (yrs)          11.1 +/- 3.5 11.1 +/- 3.3 0.90

Weight  (kg) 42.7 +/- 18.5 42.5 +/- 17.4 0.90

Body mass index (kg/m2) 19.4 +/- 4.9 19.6 +/- 4.5 0.67

Gender (% male) 55.0% 51.1% 0.53

Admission temperature (oC) 37.1 +/- 0.7 37.0 +/- 0.7 0.46

Leukocyte count (1000 cells/mm3)

14.6 +/- 5.4 14.6 +/- 5.2 0.96

Table 1- Patient Characteristics at Operation

SSULS vs 3-Port Lap.Appendectomy

Table 2 - Operative Data  Single Incision

(N=180)     3-Port

(N=180) P

Operative Time (mins) 35.2 +/- 14.5 29.8 +/- 11.6 <0.001

Surgical Difficulty (1–Easy to 5–Difficult) 2.3 +/- 1.4 1.7 +/- 1.0 <0.001

Ann Surg 254: 586-590, 2011Ann Surg 254: 586-590, 2011

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 +/- 3.7 3.7 +/- 3.1 0.25

Time to Regular Diet (Hours) 7.2 +/- 5.1 6.9 +/- 5.2 0.48

Postoperative Length of Stay (hours)   22.7 +/- 6.2 22.2 +/- 6.8 0.44

Total Doses of Analgesics 9.6 +/- 4.9 8.5 +/- 4.3 0.04

Hospital Charges ($) 17.6K +/- 4.0K 16.6K +/- 3.9K 0.005

Corrected Charges* ($) 16.8K +/- 4.1K 16.6K +/- 3.9K 0.60

Table 3 - Table 3 - Outcome Data

*Hospital charges minus the stapler charges.

Ann Surg 254: 586-590, 2011Ann Surg 254: 586-590, 2011

Ann Surg 254: 586-590, 2011Ann Surg 254: 586-590, 2011

SSULS vs 3-Port Lap.Appendectomy

  Single Incision (104)

3-Port (101) 

P

Days of Prescribed Analgesics 3.8 +/- 3.6 4.0 +/- 5.1 0.85

Doses of Prescribed Analgesics 6.4 +/- 9.3 5.1 +/- 6.6 0.37

Days to Full Activity 7.5 +/- 5.8 8.5 +/- 6.2 0.33

Days to Return to School 4.7 +/- 2.9 4.9 +/- 3.7 0.77

Table 4 - Convalescence After Hospital Discharge

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, 2011Ann Surg 254:586-590, 2011

Does Body Habitus Make a Difference?

SINGLE SITENormal (N=135)

Overweight (N=26)

P-ValueObese (N=19)

P-Value

Age (yrs) 11.0 ± 3.5 10.8 ± 3.9 0.78 12.1 ± 2.9 0.20

Weight (kg) 38.3 ± 14.5 47.4 ± 19.1 N/A 67.5 ± 22.0 N/A

Body Mass Index Percentile

41.1 ± 26.4 89.7 ± 2.8 N/A 97.5 ± 1.5 N/A

Gender (% male) 53.3 57.7 0.83 63.2 0.47

3 PORTNormal (N=139)

Overweight (N=25)

P-ValueObese (N=16)

P-Value

Age (yrs) 10.9 ± 3.4 11.9 ± 2.7 0.17 11.7 ± 3.5 0.38

Weight (kg) 37.8 ± 14.1 52.7 ± 15.3 N/A 66.8 ± 20.5 N/A

Body Mass Index Percentile 44.7 ± 26.5 89.6 ± 2.5 N/A 97.1 ± 1.7 N/A

Gender (% male) 50.4 60.0 0.40 43.8 0.79

IPEG 2012IPEG 2012

Outcomes for 3-Port Based on Body Habitus

3 PORTNormal (N=139)

Overweight (N=25)

P-ValueObese (N=16)

P-Value

Operating Time (Minutes) 29.6 ± 13.6 31.4 ±12.6 0.47 29.3 ± 20.1 0.93

Surgical Difficulty (1 – Easy to 5 – Difficult)

1.7 ± 1.0 1.6 ± 1.0 0.70 1.5 ± 0.6 0.33

Wound Infection (%) 2.2 0 1.00 0 1.00

Doses of Narcotics 5.3 ± 3.2 4.6 ± 3.2 0.31 6.2 ± 4.4 0.32

LOS after Operation (Hours)

22.5 ± 7.2 20.6 ± 5.0 0.22 21.8 ± 5.4 0.72

Hospital Charges ($) 16.4K ± 4.0K 17.2K ± 2.9K 0.32 17.1K ± 4.1K 0.51

IPEG 2012IPEG 2012

Outcomes for Single Incision Based on Body Habitus

SINGLE SITENormal (N=135)

Overweight (N=26)

P-Value Obese (N=19) P-Value

Operating Time (Minutes)

34.0 ± 13.6 34.1 ± 11.9 0.97 45.4 ± 20.1 0.002

Surgical Difficulty (1 – Easy to 5 – Difficult)

2.2 ± 1.4 2.6 ± 1.4 0.18 2.5 ± 1.4 0.38

Wound Infection (%) 1.5 7.7 0.12 10.5 0.08

Doses of Narcotics 5.7 ± 3.5 5.6 ± 3.7 0.85 7.6 ± 0.15 0.05

LOS after Operation (Hours)

22.0 ± 5.7 24.1 ± 6.7 0.11 25.4 ± 8.1 0.03

Hospital Charges ($) 17.1K ± 3.8K 18.5K ± 3.9K 0.09 20.3K ± 4.7K < 0.001

IPEG 2012IPEG 2012

Outcome Comparison for Normal Weight

NORMAL SINGLE (N=135) 3 PORT (N=139) P-Value

Operating Time (Minutes) 34.0 ± 13.6 29.6 ± 13.6 0.004

Surgical Difficulty (1 – Easy to 5 – Difficult)

2.2 ± 1.4 1.7 ± 1.0 0.002

Wound Infection (%) 1.5 2.2 0.68

Doses of Narcotics 5.7 ± 3.5 5.3 ± 3.2 0.31

LOS after Operation (Hours) 22.0 ± 5.7 22.5 ± 7.2 0.59

Hospital Charges ($) 17.1K ± 3.8K 16.4K ± 4.0K 0.13

IPEG 2012IPEG 2012

OVERWEIGHT SINGLE (N=26) 3 PORT (N=25) P-Value

Operating Time (Minutes) 34.1 ± 11.9 31.4 ±12.6 0.44

Surgical Difficulty (1 – Easy to 5 – Difficult)

2.6 ± 1.4 1.6 ± 1.0 0.006

Wound Infection (%) 7.7 0 0.08

Doses of Narcotics 5.6 ± 3.7 4.6 ± 3.2 0.32

LOS after Operation (Hours)

24.1 ± 6.7 20.6 ± 5.0 0.04

Hospital Charges ($) 18.5K ± 3.9K 17.2K ± 2.9K 0.20

Outcome Comparison for Overweight

IPEG 2012IPEG 2012

OBESE SINGLE (N=19) 3 PORT (N=16) P-Value

Operating Time (Minutes) 45.4 ± 20.1 29.3 ± 20.1 0.006

Surgical Difficulty (1 – Easy to 5 – Difficult)

2.5 ± 1.4 1.5 ± 0.6 0.014

Wound Infection (%) 10.5 0 0.11

Doses of Narcotics 7.6 ± 0.15 6.2 ± 4.4 0.42

LOS after Operation (Hours)

25.4 ± 8.1 21.8 ± 5.4 0.14

Hospital Charges ($) 20.3K ± 4.7K 17.1K ± 4.1K 0.04

Outcome Comparison for Obese

IPEG 2012IPEG 2012

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 2012IPEG 2012

SSULS vs 4-Port Lap. Cholecystectomy

Table 1 – Patient Characteristics at OperationTable 1 – Patient Characteristics at Operation

APSA 2012APSA 2012

  Single Incision   (N=30)    

4-Port (N=30) P-Value

Age (yrs)          14.0 +/- 3.2 13.3 +/- 3.3 0.39

Weight  (kg) 55.0 +/- 19.4 59.7 +/- 24.0 0.40

Gender (% male) 20% 20% 0.99

Gallstones (% present) 50% 56.7% 0.7

SSULS vs 4-Port Lap. Cholecystectomy

  Single Incision (N=30)    

4-Port (N=30)

P-Value

Time to Initial Diet (Hours) 3.8 +/- 4.7 5.2 +/- 9.2 0.41

Time to Full Diet (Hours) 6.3 +/- 5.8 7.2 +/- 9.7 0.66Postoperative Length of

Stay  (days)   1.01 +/- 0.54 0.90 +/- 0.12 0.28

Total Doses of Analgesics 16.4 +/- 17.8 10.1 +/- 4.3 0.06

Hospital Charges ($) 29.7K +/- 27.3K 20.6K +/- 6.9K 0.08

Table 2 – Operative DataTable 2 – Operative DataTable 2 – Operative DataTable 2 – Operative Data

Table 3 – Outcome DataTable 3 – Outcome Data

APSA 2012APSA 2012

  Single Incision (N=30)    

4-Port(N=30)

 P-Value

Operative Time (mins) 68.6 +/- 22.1 56.1 +/- 22.1 0.03

Surgical Difficulty (1 – Easy to 5 – Difficult)

2.7 +/- 1.0 1.9 +/- 0.8 0.005

SSULS vs 4-Port Lap. Cholecystectomy

  Single Incision 3-Port  P-Value

Days of Prescribed Analgesics 3.5 +/- 3.2 3.6 +/- 3.8 0.96

Doses of Prescribed Analgesics 7.0 +/- 5.9 3.0 +/- 2.5 0.23

Days to Full Activity 6.1 +/- 3.1 6.0 +/- 4.7 0.96

Days to Return to School 4.8 +/- 1.9 4.5 +/- 4.2 0.88

Table 4 – Convalescence After Discharge

APSA 2012APSA 2012

www.cmhclinicaltrials.comwww.cmhmis.com

QUESTIONS