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Surgical EndoscopyAnd Other Interventional TechniquesOfficial Journal of the Society ofAmerican Gastrointestinal andEndoscopic Surgeons (SAGES) andEuropean Association for EndoscopicSurgery (EAES) ISSN 0930-2794 Surg EndoscDOI 10.1007/s00464-015-4428-y

SAGES TAVAC safety and effectivenessanalysis: da Vinci® Surgical System(Intuitive Surgical, Sunnyvale, CA)

Shawn Tsuda, Dmitry Oleynikov, JonGould, Dan Azagury, Bryan Sandler,Matthew Hutter, Sharona Ross, EricHaas, Fred Brody, et al.

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CONSENSUS STATEMENT

SAGES TAVAC safety and effectiveness analysis: da Vinci�

Surgical System (Intuitive Surgical, Sunnyvale, CA)

Shawn Tsuda1 • Dmitry Oleynikov2 • Jon Gould3 • Dan Azagury4 • Bryan Sandler5 •

Matthew Hutter6 • Sharona Ross7 • Eric Haas8 • Fred Brody9 • Richard Satava10

Received: 7 July 2015 / Accepted: 9 July 2015

� Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2015

Abstract

Background The da Vinci� Surgical System (Intuitive

Surgical, Sunnyvale, CA, USA) is a computer-assisted

(robotic) surgical system designed to enable and enhance

minimally invasive surgery. The Food and Drug

Administration (FDA) has cleared computer-assisted

surgical systems for use by trained physicians in an

operating room environment for laparoscopic surgical

procedures in general, cardiac, colorectal, gynecologic,

head and neck, thoracic and urologic surgical proce-

dures. There are substantial numbers of peer-reviewed

papers regarding the da Vinci� Surgical System, and a

thoughtful assessment of evidence framed by clinical

opinion is warranted.

Methods The SAGES da Vinci� TAVAC sub-committee

performed a literature review of the da Vinci� Surgical

System regarding gastrointestinal surgery. Conclusions by

the sub-committee were vetted by the SAGES TAVAC

Committee and SAGES Executive Board. Following revi-

sions, the document was evaluated by the TAVAC Com-

mittee and Executive Board again for final approval.

Results Several conclusions were drawn based on expert

opinion organized by safety, efficacy, and cost for robotic

foregut, bariatric, hepatobiliary/pancreatic, colorectal sur-

gery, and single-incision cholecystectomy.

Conclusions Gastrointestinal surgery with the da Vinci�

Surgical System is safe and comparable, but not superior to

standard laparoscopic approaches. Although clinically

acceptable, its use may be costly for select gastrointestinal

procedures. Current data are limited to the da Vinci�

Surgical System; further analyses are needed.

Keywords Da Vinci� Surgical System � Safety �Effectiveness � Cost � Abdominal surgery � Gastrointestinalsurgery

Technology overview

The da Vinci� Surgical System (Intuitive Surgical, Sun-

nyvale, CA, USA) is a computer-assisted (robotic) surgical

system designed to enable and enhance minimally invasive

surgery. The Food and Drug Administration (FDA) has

cleared computer-assisted surgical systems for use by

& Shawn Tsuda

stsuda@medicine.nevada.edu

1 Department of Surgery, University of Nevada School of

Medicine, 1701 W. Charleston Blvd. Suite 400, Las Vegas,

NV 89102, USA

2 Department of Surgery, University of Nebraska Medical

Center, Omaha, NE, USA

3 Department of Surgery, Medical College of Wisconsin,

Milwaukee, WI, USA

4 Department of Surgery, Stanford School of Medicine,

Stanford, CA, USA

5 Department of Surgery, University of California San Diego

School of Medicine, La Jolla, CA, USA

6 Department of Surgery, Harvard Medical School, Boston,

MA, USA

7 Department of Surgery, Florida Hospital, Orlando, FL, USA

8 Department of Surgery, University of Texas Medical School

at Houston, Houston, TX, USA

9 Department of Surgery, George Washington University,

Washington, DC, USA

10 Department of Surgery, University of Washington, Seattle,

WA, USA

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DOI 10.1007/s00464-015-4428-y

and Other Interventional Techniques

Author's personal copy

trained physicians in an operating room environment for

laparoscopic surgical procedures in general, cardiac, col-

orectal, gynecologic, head and neck, thoracic and urologic

surgical procedures.

The da Vinci� Surgical System is not technically a robot

but is a computer-assisted telemanipulator. A robotic

device is a ‘‘powered, computer-controlled manipulator

with artificial sensing that can be reprogrammed to move

and position tools to carry out a wide range of surgical

tasks.’’ [1] Conversely, computer-assisted devices are not

true robots because they lack independent motions or

preprogrammed actions. The term telemanipulator, or tel-

esurgery, implies that there is a distance interposed

between the surgeon and the patient.

When using the da Vinci� Surgical System, the surgeon

sits at a console remote from the patient and manipulates

controls for the surgical instruments. The computer

enhances the interaction between the surgeon and the

bedside robotic device by eliminating tremor and scaling

all motions to a selected degree. This makes fine and

precise movements of the surgical instruments possible. In

addition, the robotic instruments are multi-articulated and

capable of a full range of motion enabling complex

maneuvers that would be difficult with standard laparo-

scopic instruments. High-definition, three-dimensional

visualization provides image detail and depth. A robotic

arm manipulates the camera, providing a steady view that

is directed by the operating surgeon. The surgeon’s hand

and instrument tip movements are synchronous.

The da Vinci� Surgical System consists of the control

console, vision system cart, and the patient-side cart. The

surgeon sits at the control console, separated from the

operative table but typically in the same room. This con-

sole is designed to provide the surgeon with an ergonom-

ically comfortable position in which he or she can

manipulate the ‘‘masters,’’ or controls. The vision system

cart includes the processor, video monitor, light source, and

other equipment related to the endoscopic camera. The cart

receives input from the camera and displays the resulting

live video on the video monitor and at the surgeon console.

The patient-side cart provides two or three robotic arms

(depending on the version and options) and one camera-

manipulating arm that execute the surgeon’s commands.

There are currently more than 50 different detachable

instruments (needle drivers, graspers, etc.) that can be

attached to the manipulator arms and exchanged as needed

during a procedure. Additional options include a dual

console that enables surgeons to work in tandem, FireflyTM

imaging (near-infrared imaging of vasculature achieved by

tracking a fluorescent dye), and single-port surgery capa-

bility (recently cleared by the FDA for laparoscopic

cholecystectomy).

Technology significance

The advantages of minimally invasive surgery when

compared with an open approach have been well docu-

mented in many surgical specialties and for many different

procedures [2–4]. These differences include decreased

duration of hospital stay, less pain, fewer wound infections

and hernias, quicker return of bowel function, and less time

to resume normal activities. In certain disciplines, most

notably urology and gynecology (prostatectomy made up

31 % and hysterectomy 41 % of all da Vinci� procedures

in 2011), robotic surgical systems have enabled increased

adoption of minimally invasive techniques by surgeons and

a move away from open surgery. When compared with

open prostatectomy, minimally invasive robotic prostatec-

tomy has been demonstrated to be associated with better

urinary continence and erectile function recovery, lower

rates of positive surgical margins, and better perioperative

outcomes [5–7]. However, when an established laparo-

scopic approach to an operation exists, the benefits of

robotic surgery when compared with laparoscopy have not

been demonstrated to be superior [8, 9].

The da Vinci� Surgical System has evolved since the

original version was released in 2000 at the time of FDA

approval. In 2006, the S version was released, followed by

the Si in 2009 and the Si-e in 2010 (Si-e is a more basic

version of the Si with three robotic arms rather than four).

On April 1, 2014, the newest intuitive system, the da

Vinci� Xi, was cleared by the FDA (Xi has an overhead

arm and thinner arms which allow greater range of motion

and placement of any instrument or the camera through any

port). According to the 2012 Intuitive Surgical Annual

Report, there were 2585 da Vinci� Surgical Systems

installed worldwide, including 1878 in the USA, 416 in

Europe, and 291 in the rest of the world [10]. In 2013,

approximately 523,000 surgical procedures were per-

formed with the da Vinci� Surgical System, up 16 %

compared with approximately 450,000 procedures per-

formed in 2012. The growth in overall 2013 procedure

volume was driven by the growth in US general surgery

procedures, US gynecologic procedures, and urology pro-

cedures outside of the USA [11].

The 2013 list price of a da Vinci� Si system (without

dual console, single-site platform, FireflyTM, or simulator)

was $1.75 million. The annual service fee is approximately

$150,000, and the estimated added consumable cost per

procedure is $1600 compared with open surgery [1].

Insurance companies generally provide coverage and

reimbursement for robotic procedures at the same rate as

conventional laparoscopic surgery. In order to recoup the

added expense of robotic surgery, cost savings through

length of stay reductions and decreased complications must

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theoretically be coupled with high caseloads. The cost-ef-

fectiveness of robotic surgery has not yet been shown.

Clinical evidence summary

Data have been published for multiple general and gas-

trointestinal surgeries with robotic surgery, including

cholecystectomy, esophagectomy, fundoplication, Heller

myotomy, gastrectomy, splenectomy, pancreatectomy,

liver resection, colectomy, sleeve gastrectomy, and Roux-

en-Y gastric bypass.

Foregut surgery

Use of the da Vinci� Surgical System in operations

involving the foregut comprises some of the largest data

sets for robotic gastrointestinal surgery, mainly in Nissen

fundoplication and Heller myotomy [12–15].

A robotic-assisted laparoscopic Heller myotomy

(RALHM) was first reported in 2001 followed by a small

case series [16–18]. An academic robotic surgery group,

comprising surgeons from Ohio State University, Johns

Hopkins University, and the University of Illinois at Chi-

cago, prospectively collected data on 104 robotic Heller

myotomies without any perforations. Both laparoscopic and

robotic techniques were safe and associated with low

occurrence of complications. However, no clear benefit was

seen in the robotic group. Some studies have demonstrated a

lower incidence of esophageal perforation with the use of

robotic assistance than reported for conventional laparo-

scopic techniques. Melvin et al. [29] demonstrated the fea-

sibility of robotic assistance for 104 patients, with a mean

operative time of 140 min, no esophageal perforations, and

only one conversion to an open procedure. In the series by

Galvani et al. [30], 54 patients underwent RALHM with no

esophageal perforations, minimal blood loss, and an average

hospital stay of 1.5 days. The average operative time was

162 min, and 93 % of the patients had no dysphagia during

an average follow-up period of 17 months. Iqbal et al. [31]

demonstrated a 7.8 % esophageal perforation rate with the

standard laparoscopic technique and no esophageal perfo-

rations in the 19 patients undergoing RALHM. Horgan et al.

[32] reported an esophageal perforation rate of 16 % in their

LHM group compared with 0 % for the RALHM patients.

Similar results regarding the robotic telesurgical approach

were obtained in three subsequent published series com-

paring robotic Heller myotomy with laparoscopic Heller

myotomy [20, 21].

Melvin et al. [19] reported a comparison case series of

gastroesophageal fundoplication performed by standard

laparoscopy or with robotic telesurgical assistance. Several

randomized studies have examined the utility of robotic

Nissen fundoplication for treatment of gastroesophageal

reflux disease (GERD) [22, 23]. These studies compared

robotic Nissen fundoplication (RF) to laparoscopic Nissen

fundoplication. Both studies quoted increased operative

times for patients within the robotic groups.

The short-term outcomes of robotic paraesophageal

hernia repair (RPEH) are not well reported in the literature

[24, 25]. Several studies had reported that RPEH is not

associated with statistically significant increases in opera-

tive times when compared with RF [26]. It has been sug-

gested that technically superior hiatal repairs can be

achieved with RPEH, although in long-term follow-up

comparisons to a laparoscopic PEH cohort this has not

been shown [27, 28].

Other data have looked at operative time and cost com-

paring robotic fundoplication to laparoscopic fundoplication.

Several randomized trials were conducted comparing robotic

and laparoscopic fundoplication, which demonstrated that

short-term outcomes were similar in both groups, with

increased hospital cost seen in the robotic group [33–35].

Most recently, Owen et al. [51] with Oleynikov at the

University of Nebraska Medical Center analyzed 12,079

patients from the University Health System Consortium and

found for Nissen fundoplication similar outcomes between

robotic and laparoscopic approaches except for increased cost

(US$10,644 ± 6041 vs. US$$12,766 ± 13,982, p\ 0.05).

Robotics in the management of gastric cancer has been

employed, first reported by Giulianotti in 2003 [36]. There

are comparison series between robotic and laparoscopic

gastrectomy [37–46]. Some of the results are: The overall

conversion rate is between 0–10 %, mean operating time

ranges from 293.8 to 656 min, and there is a noticeable

decrease in time for robotic system setup as registered over

2 years. Estimated mean blood loss ranged from 65 to

300 ml. Specific morbidity ranges from 9 to 30 % in the

literature. Mortality varies between 0 and 9 % [47–49].

There is additional data looking specifically at oncologic

outcomes in robotic versus laparoscopic or open surgery.

Kim et al. [50] provided comparison-effectiveness infor-

mation regarding robotic surgery versus laparoscopic or

open gastrectomy for the treatment of gastric cancer. The

authors compared the results of robotic gastrectomy using

the da Vinci� Surgical System with those for 11 laparo-

scopic and 12 open gastrectomies. The total number of

lymph nodes retrieved was used as a quality control mea-

sure in gastric, colorectal, and other cancers and did not

differ significantly among the groups. Robotic surgery was

associated with significantly less blood loss and a shorter

postoperative hospital stay.

Overall studies suggest that robotic foregut surgery is

safe; however, no improvement in outcomes has been

shown and costs are increased.

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Bariatric surgery

The use of robotic technology has been increasingly

reported in bariatric surgery, including five systematic

reviews [52–56]. The only procedure studied in any vol-

ume is the Roux-en-Y gastric bypass. A totally robotic

laparoscopic RYGBP procedure using the da Vinci� Sur-

gical System has been described as a safe and effective

alternative to open or laparoscopic techniques.

The published reviews report non-inferiority of the

robotic approach when compared with standard laparo-

scopy. However, they fail to demonstrate superiority,

pointing to the lack of high-quality data. A single ran-

domized trial exists showing equivalent outcomes [57].

Other large trials include case control studies with up to

400 patients per group or case series (one including over

1000 robotic RYGB) [58–69]: These studies all confirm

non-inferiority of the robotic approach, and most demon-

strate some benefit when compared with laparoscopy in

reduction in gastrojejunal (GJ) leak rates, reduced strictures

rates, or reduced length of stay. Data also consistently

show longer operative times in the robotic groups. Repor-

ted rates of complications after stapling at the GJ are

1.1–6.0 % leak rate, 2.9–27.1 % stricture rate, and 1.6 %

rate of intraluminal bleeding [70–72].

Robotic approaches can facilitate hand-sewn GJ creation

that offers several advantages to the bariatric surgeon

compared with laparoscopy. The most important advantage

is that the added degrees of freedom of the needle driver

allow for precise, ambidextrous forehand and backhand

suture placement [73]. The angles encountered in the cre-

ation of the laparoscopic GJ are sometimes awkward and

can make the anastomosis technique challenging. With

robotic surgery, this additional challenge is potentially

minimized. A completely hand-sewn robotic gastrojejunal

anastomosis appears to be feasible and although it may

even be less technically challenging than a pure laparo-

scopic hand-sutured approach, there is no data. However,

since the standard is a stapled anastomosis, there appears to

be no difference in either safety or outcomes between

laparoscopic and robotic approaches.

Hepatobiliary/pancreatic surgery

The use of the da Vinci� Surgical System to perform liver

resection has been described by several authors in a variety

of case series for both benign and malignant hepatic

resections [74–85]. The challenge in fully evaluating this

technology for this application is that no randomized,

controlled data exist to compare robotic assistance with

conventional laparoscopy for hepatic resections.

A systematic review of the literature reports 19 series of

robotic-assisted liver resection that included 236 robotic

procedures in 219 patients [86]. Both benign and malignant

lesion resections were included in the series with tumor

size of up to 6.4 cm. Robotic-assisted wedge resection or

segmentectomy was the most commonly performed pro-

cedure (37.7 %), followed by right hepatectomy (21.6 %),

left lateral segmentectomy (20.8 %), left hepatectomy

(13.1 %), and bisegmentectomy (5.1 %). Also included in

the series were two right trisegmentectomies (0.8 %), an

extended right hepatectomy (0.4 %), and a right live donor

hepatectomy (0.4 %). Liver parenchymal transection was

performed using robotic ultrasonic dissection or robotic

bipolar electrosurgery after tissue crushing, while vessel

transection was performed with clip application, ligature,

or with running suture. Conversion to open surgery was

performed in 10 cases (4.6 %), most commonly for unclear

margins or bleeding. No mortality was reported. Morbidity

was cited in 20.3 % of cases (48/236), the most common

being intra-abdominal bile collection/abscess in 6.6 % of

procedures. Operative duration ranged from 200 to

507 min.

A few non-randomized, comparative cohort studies

exist, comparing robotic liver resection with laparoscopic

and open hepatic surgery [87, 88]. A comparative study

showed no time difference between robotic and conven-

tional laparoscopic liver resection, while others suggested

longer robotic surgical times when compared with laparo-

scopic or open techniques (253 min vs. 199 min, respec-

tively). Estimated blood loss was not significantly different

from that of laparoscopic liver resection although direct

comparison with laparoscopic hepatectomy showed that

the robotic approach allowed for increased percentage of

hepatectomies to be completed in a purely minimally

invasive fashion (81 % vs. 7.1 %) [88]. Similar disease-

free survival was seen when robotic resection of mixed

malignancies was compared with laparoscopic resection

[74, 76, 82]. With a lack of true randomized, controlled

data comparing robotic hepatectomy with laparoscopic or

open hepatectomy, no significant conclusions can be made

comparing the procedures. Robotic hepatectomy is feasi-

ble, as demonstrated in several series, but true compar-

isons, especially to help evaluate oncologic and other

patient outcomes, cost-effectiveness, and morbidity and

mortality differences cannot be determined with existing

data.

Similar to robotic-assisted hepatic procedures, robotic-

assisted pancreatic surgery has been described in several

case series for both benign and malignant diseases [89, 90].

Again, no randomized, controlled trials exist comparing

robotic pancreatic surgical procedures with laparoscopic or

open surgical procedures, but several series have

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demonstrated safe outcomes in select patients. Pancreatic

resections described using robotic assistance include:

pancreaticoduodenectomy, distal pancreatectomy, central

pancreatectomy, pancreatic enucleation, total pancreatec-

tomy, Appleby resection, and Frey procedure. No direct

comparison studies look at open versus laparoscopic versus

robotic pancreatectomy in a randomized, controlled,

prospective fashion, so drawing definitive conclusions

about the superiority of a robotic approach in pancreatec-

tomy is not possible.

Multi-port cholecystectomy has been performed with

robotic assistance, and is commonly used as a procedure

for surgeons to gain comfort with the robotic platform early

in their learning curve. There is insufficient data, however,

to support robotic cholecystectomy outside of training

purposes.

Colorectal surgery

Adaptation of the da Vinci� system for colorectal proce-

dures was first reported by Weber et al. in 2002 [91]. They

found that the robot overcame several of the inherent

limitations of conventional laparoscopy, although a much

longer operative time was required. Delaney et al. [92]

evaluated perioperative outcomes for six matched robotic

versus laparoscopic colorectal procedures in 2003. Their

robotic procedures were associated with an increased

operative time; however, incision length, blood loss, and

length of hospitalization were similar between the groups.

Several other authors have also reported their early

assessment of da Vinci� robotic colorectal surgery [93–

98]. Although some variability exists, the early phases of

robotic literature generally revealed similar conclusions

showing comparable short-term results compared with

laparoscopy with lower blood loss, and increased length of

surgery and cost [99, 100].

True benefits of robotic colorectal surgery have not been

shown. The potential benefits of robotic colorectal surgery

may be seen in cases involving rectal and pelvic dissection,

but proven benefits have not been demonstrated [101].

There is, however, literature examining the robotic

approach for colorectal cases involving rectal and pelvic

anatomy [102]. Some have shown positive outcomes for a

quality total mesorectal excision (TME) and cylindrical

excision for low rectal cancers [103–105]. It has also been

suggested that in the obese and male gender, robotic sur-

gery is associated with decreased blood loss and lower

rates of conversion. Nearly all studies have shown, how-

ever, that the robotic platform results in prolonged opera-

tive times as well as higher costs compared with

laparoscopy. Some surgeons advocate for robotic right

colectomy; however, unlike its role in pelvic anatomy, no

significant advantages over existing minimally invasive

techniques in regard to technical considerations and out-

comes have been shown [106, 107]. In light of the

increased resources required for robotic surgery, its role in

non-rectosigmoid procedures is limited at this time.

At present, the greatest utilization for continued

advancements with robotic colorectal surgery is centered

on techniques and outcomes for total mesorectal excision

(TME) [108, 109]. Although 45 % of colectomies are

performed laparoscopically in the USA, less than 10 % of

rectal resections are performed using a minimally invasive

approach. Robotic surgery has been touted as an enabling

technology for rectal resections, and it is estimated that

nearly half of minimally invasive rectal cases are per-

formed robotically [109]. These procedures involve pelvic

anatomy in which critical structures are located in a con-

fined and restricted anatomical location, which is even

more pronounced in the male or obese patient. Numerous

authors contend that the 3D visualization and wristed

instruments afford advantages for mesorectal excision and

nerve-sparing over conventional laparoscopic technique

[110–112]. The published literature is yet to validate such

benefits, with some studies showing advantages and others

demonstrating non-inferiority for robotic rectal resec-

tion. However, the literature does consistently reveal sim-

ilar short-term outcomes with longer operative times and

higher costs [113, 114]. Some early studies have shown

trends toward better sexual or bladder function; neverthe-

less, this has not reached significance and has yet to be

proven [115, 116]. Currently, randomized control trials are

looking to answer these and other questions regarding the

widespread role of robotic surgery for rectal cancer [117].

Procedures for benign diseases such as rectal prolapse

and complicated diverticulitis have been reported [118–

121]. No clear advantage has been shown over laparo-

scopy. Overall, these studies have shown similar short-term

outcomes with lower blood loss at the expense of longer

operative times and higher costs similar to the TME data.

Rectal surgery, either by laparoscopy or utilizing the

robotic platform, is still considered more technically

challenging than open colon resection. As such, some

would suggest only employing robotics for the treatment of

rectal pathology once the early phase of the learning curve

is achieved. There are few studies that have evaluated the

learning curve for robotic colorectal surgery. Spinoglio

et al. [122] aimed to assess surgical and oncological

advantages of robotic colorectal surgery for cancer in 2010.

They noted that operative time decreased as their experi-

ence increased (419 min in the first 20 cases vs. 346 min in

the last 30 cases; p = 0.036). In 2011, Bokhari et al. [123]

utilized a cumulative sum (CUSUM) methodology to cre-

ate a three-phase learning curve from a series of 50 con-

secutive robotic rectal cases. They concluded that the

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learning phase for robotic rectal surgery was achieved after

15 to 25 cases. Similar observations were noted by Jime-

nez-Rodrıguez et al. and Sng et al. [124, 125]. While there

is no consensus on the exact number of cases required to

overcome the learning curve, it is acknowledged that

competency with laparoscopic colectomy is recommended

prior to operating the robotic system for rectal procedures

[126].

At present, no significant benefits have been realized

with regard to operative time or patient-related outcomes

following robotic colorectal surgery. Without significant

reductions in operative time or length of stay, meaningful

cost reductions cannot be realized. Utilization of this

platform should be rationalized on a case-by-case basis,

especially for cases with pelvic anatomy or unfavorable

patient characteristics such as obesity or low rectal tumors.

Efforts can be made toward developing improved instru-

mentation as well as optimizing the approach and lowering

of times and costs [127, 128]. Until such time, the uti-

lization of the robotic platform for rectal pathology should

be reserved for cases and pathologies in which the surgeon

feels it affords true benefits that outweigh the increased

resources of this approach.

Single-port robotic colorectal surgery has been per-

formed but has not been evaluated outside of small series

and initial experiences [129–131]. Use of the da Vinci�

platform has also been extended for use in transanal sur-

gery, with several authors demonstrating safety and feasi-

bility in combination with transanal minimally invasive

surgery (TAMIS) [132–134]. This is early data, and further

studies will need to be performed to know whether there is

any benefit to this approach.

Single-incision robotic cholecystectomy

With the introduction of the single-incision Da Vinci�

robotic platform, several institutions have described their

experience with this technology for robotic cholecystec-

tomy [135–145]. It appears that, with adequate experience,

the use of this technology for single-incision robotic-as-

sisted cholecystectomy is safe and feasible. In addition to

the use of a novel robotic platform, this technology also has

the capability of fluorescent imaging using an integrated

near-infrared camera following indocyanine green (ICG)

administration for real-time visualization of biliary anat-

omy. This has been advocated by some groups to help

facilitate bile duct visualization during the procedure in

efforts to reduce biliary injury [146]. The real-time visu-

alization of a patient’s biliary anatomy requires a simple

push of a button to swap between the white-light and the

near-infrared camera filter feature built into the most recent

robotic system.

While convenient for deciphering obscure anatomy

quickly, the true reliability of this single-incision robotic

surgery approach awaits further clinical trials. Similar to

hepatic and pancreatic surgery, no randomized, controlled

trials exist comparing robotic single-incision cholecystec-

tomy with either traditional four-trocar laparoscopic chole-

cystectomy or conventional single-incision laparoscopic

cholecystectomy and any advantages that the robotic system

offers must await this analysis before definitive conclusions

can be made. There are also ample data that the costs are

higher with the robotic approach. Robotic cholecystectomy

cannot, therefore, be recommended currently as a modality

to be used for routine cholecystectomy.

Ongoing trials

A review of clinicaltrials.gov (accessed 2/19/2014) was

performed to identify current clinical studies regarding

robotic surgery:

• Robotic versus laparoscopic resection for rectal cancer:

This study at the University of California, Irvine, aims

to compare two different surgical procedures for the

treatment of rectal cancer: laparoscopic surgery and

robotic-assisted laparoscopic surgery. The ROLARR

study is for participants with cancer of the rectum for

whom a laparoscopic operation has been recommended

by their surgeon.

• Efficacy study of robotic surgery for rectal cancer: This

study from the National Cancer Center, Korea, aims to

evaluate the effectiveness and safety of robotic surgery

in mid- or low rectal cancer.

• Robotic-assisted versus laparoscopic cholecystec-

tomy—Outcome and cost analyses of a case-matched

control study: This study from the University of Zurich

is a case-matched study on 50 consecutive patients

undergoing robotic-assisted cholecystectomy. These

patients are matched 1:1 to 50 patients with conven-

tional laparoscopic cholecystectomy, according to age,

gender, ASA score, histology, and surgical experience.

• A trial to assess robot-assisted surgery and laparoscopy-

assisted surgery in patients with mid- or low rectal

cancer: This study from Kyungpook National Univer-

sity will assess the safety and benefit of robotic

resection compared with conventional laparoscopy-

assisted resection for curative treatment of patients

with cancer of the mid- or low rectum.

• Laparoscopic surgery versus robot surgery for right-

side colon cancer: short-term outcome of a randomized

clinical trial: This study from Kyungpook National

University is a randomized controlled trial designed to

determine the safety and efficacy of robotic right

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hemicolectomy in comparison with laparoscopic right

hemicolectomy.

• Clinical and health economic impact of robot-assisted

surgery versus conventional laparoscopy: the case of

gastric bypass: This study from IHU Strasbourg aims to

gather clinical and economic evidence on the use of

robotics for bariatric surgery (gastric bypass). This

monocentric, randomized, single blind, controlled study

will evaluate postoperative pain, quality of life and

appetite, and postoperative complication incidence. It

will also provide information on direct and indirect

costs of surgery.

• Laparoscopic ‘‘da VINCI�’’ robot-assisted abdominal

wall hernia repair: This study from assistance Pub-

lique—Hopitaux de Paris aims to prove the superiority

of the robotic assistance in laparoscopic repair of

abdominal wall hernias. In this monocentric random-

ized controlled trial, the use of the DA VINCI� robot

might reduce the postoperative pain of the patient

resulting in a 40 % reduction in morphine consumption.

• Fluorescence versus intraoperative cholangiography in

the visualization of biliary tree anatomy: This study

from IHU Strasbourg looks at different techniques that

have been proposed to prevent bile duct injury.

• Cosmesis, patient satisfaction, and quality of life after

da Vinci� single-site and multiport laparoscopic chole-

cystectomy: This study by Intuitive Surgical is a

prospective, randomized, multicenter study comparing

cholecystectomy performed with da Vinci� Single-Site

InstrumentsTM to multi-port (four ports) laparoscopy.

• The clinical study of making the evidence with applica-

tion of Da Vinci� robot-assisted low anterior resection in

rectal cancer: This study from Yonsei University inves-

tigates evidence with application of Da Vinci� robot-

assisted low anterior resection in rectal cancer.

• Fluorescence imaging on the da Vinci� Surgical

System for intra-operative near-infrared imaging of

the biliary tree (up to 2 weeks postoperatively): This

study by Intuitive Surgical hypothesized that the da

Vinci� Fluorescence Imaging Vision System provides

real-time endoscopic near-infrared fluorescence imag-

ing of the biliary anatomy as defined as identifying

biliary vessels; either cystic duct, common hepatic duct

(CHD), or common bile duct (CBD). Irradiation given

to the patient during a classic cholangiography can be

reduced.

Expert subcommittee recommendation

This expert panel convened by the SAGES Technology and

Value Assessment Committee finds that:

With regards to safety

• The da Vinci� Surgical System for gastrointestinal

surgery does not demonstrate increased morbidity or

mortality compared with laparoscopic surgery.

• With proper training, there is enough data to regard the

da Vinci� Surgical System as safe. As with any new

surgical technology, complications may be more likely

without adequate training.

With regard to efficacy

• Surgery with the da Vinci� Surgical System is as

effective, but not demonstrated to be superior to con-

ventional laparoscopic surgery of the gastrointestinal

tract. It appears to have similar benefits to laparoscopic

surgery when compared with open.

• There is insufficient data to know whether the onco-

logic outcomes in surgery using the da Vinci� Surgical

System are equivalent or superior to conventional

laparoscopic surgery.

With regard to cost

• The da Vinci� Surgical System is more costly,

including fixed costs for the equipment and servicing,

as well as per case cost in terms of OR time, and use of

consumables.

• Published data assessing the value of da Vinci� robotic

surgery do not exist, in both the short and long term,

taking into account direct and indirect measures of cost

and quality. Future analyses should include quality and

costs to the health-care system as a whole.

Conclusions

• Gastrointestinal surgery with the da Vinci� Surgical

System is safe and comparable to standard laparoscopic

approaches.

• Surgical outcomes with the da Vinci� Surgical System

are not superior to laparoscopy.

All studies that have evaluated costs indicate an increase in

procedure-related costs, and frequently in OR time-related

costs.

• On the basis of available evidence, this panel concludes

that the da Vinci� Surgical System is a clinically

acceptable but costly platform for use in selected

gastrointestinal procedures such as Heller myotomy,

Nissen fundoplication, paraesophageal hernia repair,

Surg Endosc

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gastrectomy, liver resection, pancreatic resections,

bariatric surgery, and colorectal surgery.

• Data do not support a role for multi-port robotic

cholecystectomy outside of its use for developing

familiarity with robotic platforms by surgeons early in

their learning curve.

• There are insufficient data supporting the use of single-

port platforms for robotic cholecystectomy.

• Current data are limited to the da Vinci� Surgical

System. Further analyses will be needed as other

devices are introduced.

Disclosures Dr. Brody is a consultant for Covidien, ViiNetwork,

Medtronic, Ethicon, and Cooper Surgical. Dr. Gould is on the advi-

sory committee for Torax Medical. Dr. Oleynikov is a board member

for Vitrual Incision Corporation and receives research grant from

LifeCell Corporation. Dr. Ross is a speaker for Olympus and con-

sultant for Covidien. Dr. Sandler is a speaker for Bard-Davol, Inc. and

Ethicon, Inc., and is a consultant for ValenTx, Inc. Dr. Satava

receives a research grant from Institute of Surgical Excellence, and is

a consultant for Kingdom of Saudi Arabia—Minister of Health and

InTouch. Dr. Tsuda is a proctor for Intuitive Surgical and is a speaker

for Acelity. Dr. Azagury, Dr. Haas, and Dr. Hutter have nothing to

disclose.

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