Single Incision Laparoscopic Cholecystectomy: Is it the way to go? Clarence Mak Prince of Wales Hospital

Introduction The first laparoscopic cholecystectomy was performed in 1987 by Phillip Mouret The first laparoscopic cholecystectomy was performed in 1987 by Phillip Mouret Advantages of laparoscopic cholecystectomy -less postoperative pain Advantages of laparoscopic cholecystectomy -less postoperative pain -shorter recovery times -shorter recovery times -better cosmetic results -better cosmetic results Laparoscopic cholecystectomy Laparoscopic cholecystectomy  gold standard of care for gallbladder removal

Introduction Efforts have been made to further reduce surgical access trauma Efforts have been made to further reduce surgical access trauma Reducing wound size Reducing wound size  needlescopic surgery (2-3mm port  needlescopic surgery (2-3mm port size) size) Reducing wound number Reducing wound number  single incision laparoscopic surgery  single incision laparoscopic surgery

The single incision technique for laparoscopic cholecystectomy was first described in 1997 by Navarra et al The single incision technique for laparoscopic cholecystectomy was first described in 1997 by Navarra et al 10mm trocars placed inside a single umbilical incision, and 3 trans-abdominal stay sutures to aid in gallbladder retraction 10mm trocars placed inside a single umbilical incision, and 3 trans-abdominal stay sutures to aid in gallbladder retraction Navarra G, Pozza E, Occhionorelli S, et al. One-wound laparoscopic cholecystectomy. Br J Surg. 1997;84:695.

Different Methods/ Variations of SILC Multiple trocars/ ports placed side by side via a single long umbilical incision of 1.5 – 2.0cm Multiple trocars/ ports placed side by side via a single long umbilical incision of 1.5 – 2.0cm Special techniques such as sutures and hooks to replace retraction instruments, reducing the number of instruments required Special techniques such as sutures and hooks to replace retraction instruments, reducing the number of instruments required

Different Methods/ Variations of SILC Special access devices for the introduction of laparoscope and multiple instruments Special access devices for the introduction of laparoscope and multiple instruments

Proposed benefits of SILC Fewer port sites with a reduced risk of wound infection Fewer port sites with a reduced risk of wound infection Faster recovery Faster recovery Less post-operative pain Less post-operative pain Improved cosmesis Improved cosmesis

Possible disadvantages of SILC Technical challenges Technical challenges -Conflicts between instruments  “ Sword fighting ” -Conflicts between instruments  “ Sword fighting ” -Reduced triangulation -Reduced triangulation Steep learning curve Steep learning curve Prolonged operation time Prolonged operation time Safety concern Safety concern Decreased visualization or exposure, ? leading to an increased risk of CBD injuries Decreased visualization or exposure, ? leading to an increased risk of CBD injuries

Review of current evidence Conversion rate Conversion rate Operation time Operation time Pain Pain Cosmesis Cosmesis Complications & Bile Duct Injury Rate Complications & Bile Duct Injury Rate

Conversion rate

Single-incision laparoscopic cholecystectomy: a systematic review Stavros A. Antoniou, Rudolph Pointner and Stavros A. Antoniou, Rudolph Pointner and Frak A. Granderath Surg Endoscopy (2011) 25: studies including 1166 patients in total Success rate of 90.7 % (conversion rate 9.3%) 0.4% of patients required conversion to open surgery 0.4% of patients required conversion to open surgery Common reasons for technical failureCommon reasons for technical failure  obscure anatomy of the Calot ’ s triangle due to adhesions, acute or chronic inflammation (5.2%) adhesions, acute or chronic inflammation (5.2%)  inadequate exposure of the Calot ’ s triangle due to insufficient gallbladder retraction (2.6%) insufficient gallbladder retraction (2.6%)

Conversion rate 8 of included prospective RCTs reported on conversion rates8 of included prospective RCTs reported on conversion rates SILC group  9.63%SILC group  9.63% Conventional LC group  0.67%Conventional LC group  0.67% Meta-analysis of conversions confirmed the results with a pooled OR ofMeta-analysis of conversions confirmed the results with a pooled OR of ANZ J Surg 82 (2012)

Operation time

Thirteen of the RCTs reported on the length of operationThirteen of the RCTs reported on the length of operation One study showed a mean time of 88.5min in SILC vs 44.8min in conventional LCOne study showed a mean time of 88.5min in SILC vs 44.8min in conventional LC Pooled estimate  mean difference of 11.6 in favour of conventional LCPooled estimate  mean difference of 11.6 in favour of conventional LC Surg Laparosc Endosc Percutan Tech 2012;22:487 – 497

Operation time Operative times tended to be longer in studies enrolling patients with a BMI > 30kg/m2 (83.4 vs 74.5)Operative times tended to be longer in studies enrolling patients with a BMI > 30kg/m2 (83.4 vs 74.5) Acute cholecystitis as an inclusion criteria resulted in an increase of surgical time (78.1 vs 70.6min)Acute cholecystitis as an inclusion criteria resulted in an increase of surgical time (78.1 vs 70.6min)

Operative time Sources of bias: Sources of bias:  Steep part of learning curve when small studies were published during early experience of SILC  Included studies with a wide variation of technical methods with regard to the number, type, and size of the trocars, the instrumentation, and the preferred method of gallbladder anchorage and exposure of the Calot ’ s triangle

Pain

Pain 40 patients included in this RCT40 patients included in this RCT Assessment of post-op painAssessment of post-op pain -visual analog scale (1-10) -visual analog scale (1-10) -2, 4, 6, 12, 24, 48, 72 hours postoperatively -2, 4, 6, 12, 24, 48, 72 hours postoperatively Significantly lower abdominal pain scores observed in SILS group > 12Significantly lower abdominal pain scores observed in SILS group > 12 hours hours Total pain non-existent after the first 24 hour in SILS groupTotal pain non-existent after the first 24 hour in SILS group Request for analgesics significantly less in SILS groupRequest for analgesics significantly less in SILS group

Pain

Pain 51 patients with symptomatic gallstones or GB polyps randomized51 patients with symptomatic gallstones or GB polyps randomized Difference in pain score of 1 in the visual analog scale (1-10) Difference in pain score of 1 in the visual analog scale (1-10) Statistically significant, but clinical significance to be determinedStatistically significant, but clinical significance to be determined

Cosmesis

Cosmesis Difference in cosmetic score at 3 months after surgery of 1Difference in cosmetic score at 3 months after surgery of 1

Cosmesis 6 of the included RCTs examined cosmesis at 1 month6 of the included RCTs examined cosmesis at 1 month Pooled analysis showed improved cosmesis in SILC group at 1 monthPooled analysis showed improved cosmesis in SILC group at 1 month Surg Laparosc Endosc Percutan Tech 2012;22:487 – 497

Cosmesis RCT RCT  patients not blinded, leading to bias Meta-analysis Meta-analysis  Patient only given chance to rate own scars, with no chance to compare cosmetic result of another procedure  Short follow-up times in most studies with time dependent changes (scarring) not assessed

Complications & Bile Duct Injury

Complications Complication rate 6.1%Complication rate 6.1% Common intra-operative complicationsCommon intra-operative complications - gallbladder perforation/ bile spillage (2.2%) - gallbladder perforation/ bile spillage (2.2%) hemorrhage (0.3%) - hemorrhage (0.3%) Common post operative complicationsCommon post operative complications -wound infection and hematoma (2.1%) -wound infection and hematoma (2.1%) -bile leakage (0.4%) -bile leakage (0.4%)

Complications Annals of Surgery Volume 256, Number 1, July studies included, total of 2626 patients

Results Complication rate Complication rate - complications were graded according to the Dindo-Clavien Classification System - aggregate complication rate was 4.2%

Results Bile Duct Injury Bile duct injuries were classified according to the Strasberg Bile Duct Injury Classification Bile duct injuries were classified according to the Strasberg Bile Duct Injury Classification Nineteen bile duct injuries were identified for a SILC- associated bile duct injury rate of 0.72%. Nineteen bile duct injuries were identified for a SILC- associated bile duct injury rate of 0.72%. 58% (11 out of the 19) were categorized as type A 58% (11 out of the 19) were categorized as type A

Complications Short follow-up periods Short follow-up periods  Long term wound complications such as incisional hernia could not be assessed  Long term wound complications such as incisional hernia could not be assessed

Bile Duct Injury Accepted historic bile duct injury rate of 0.4% to 0.5% for standard laparoscopic cholecystectomy* Accepted historic bile duct injury rate of 0.4% to 0.5% for standard laparoscopic cholecystectomy* 0.76% for SILC 0.76% for SILC *Nuzzo G, Giuliante F, Giovannini I, et al. Bile duct injury during laparoscopic cholecystectomy: results of an Italian national survey on cholecystectomies. Arch Surg. 2005;140:986 – 992. Waage A, Nilsson M. Iatrogenic bile duct injury: a population-based study of 152,776 cholecystectomies in the Swedish Inpatient Registry. Arch Surg. 2006;141:1207 – Flum DR, Dellinger EP, Cheadle A, et al. Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy. JAMA. 2003;289:1639 – 1644.

However, the rate of bile duct injuries may even be higher, since …….

1. Most SILCs performed under ideal conditions  absence of acute cholecystitis (90.6%)  absence of acute cholecystitis (90.6%) 2. Publication bias  compilation of results using multiple small studies  compilation of results using multiple small studies  important negative events (i.e. bile duct injury) underreported  important negative events (i.e. bile duct injury) underreported

Bile Duct Injury Is there a more accurate way to know the exact incidence? Is there a more accurate way to know the exact incidence? Low incidence of bile duct injury known (0.4%) Low incidence of bile duct injury known (0.4%)  High powered randomized controlled study not feasible since a large number of patients would have to be enrolled (i.e up to thousands)

Is SILC the way to go?

Conventional laparoscopic cholecystectomy is a well established technique with satisfactory outcome and hard to improve upon Conventional laparoscopic cholecystectomy is a well established technique with satisfactory outcome and hard to improve upon Cosmesis being a major attraction of SILC Cosmesis being a major attraction of SILC “ As surgeons, should we advocate for an improved cosmetic value over safety? ” “ As surgeons, should we advocate for an improved cosmetic value over safety? ”

To conclude ….. Limited evidence on SILC vs conventional LC may have shown improved pain and cosmesis Limited evidence on SILC vs conventional LC may have shown improved pain and cosmesis Incidence of bile duct injury apparently higher, with exact incidence still unknown Incidence of bile duct injury apparently higher, with exact incidence still unknown Until there is further data to suggest that SILC is as safe as conventional LC, it should not be adopted as a routine surgical procedure for the removal of gallbladder Until there is further data to suggest that SILC is as safe as conventional LC, it should not be adopted as a routine surgical procedure for the removal of gallbladder

SILC is an exciting technological advancement in minimally invasive surgery SILC is an exciting technological advancement in minimally invasive surgery Development of new instruments to overcome technical barriers, such as curved instruments, may make SILC easier and safer to perform in the future Development of new instruments to overcome technical barriers, such as curved instruments, may make SILC easier and safer to perform in the future

Thank you With a special thanks to my mentors: Dr. KF Lee, Dr. Sunny Cheung & Dr. HC Yip HBP team, PWH Surgery