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Clinical Evidence  Single Site™ da Vinci ® Surgery for Gallbladder Disease

Featured Publications

Many people want to know how medical innovations can impact their health. One of the ways to find out about the pros and cons of drugs, medical devices and surgical techniques is to become familiar with peer-reviewed clinical publications. In these articles, researchers report on their findings on whether a treatment is safe, appropriate and effective.

Our bibliography contains thousands of such publications and is growing at a rate of approximately 100 new titles per month. The vast majority of these studies are researched and written independently of Intuitive Surgical, Inc. Below is a clinical bibliography of featured publications representing Single-Site da Vinci Surgery.

1. Spinoglio G, Lenti LM, Maglione V, Lucido FS, Priora F, Bianchi PP, Grosso F, Quarati R. Single-site robotic cholecystectomy (SSRC) versus single-incision laparoscopic cholecystectomy (SILC): comparison of learning curves. First European experience. Surg Endosc. 2012 Jun;26(6):1648-55. Epub 2011 Dec 17.

BACKGROUND: Single-incision laparoscopic surgery is an emerging procedure developed to decrease parietal trauma and improve cosmetic results. However, many technical constraints, such as lack of triangulation, instrument collisions, and cross-handing, hamper this approach. Using a robotic platform may overcome these problems and enable more precise surgical actions by increasing freedom of movement and by restoring intuitive instrument control. Methods We retrospectively collected, under institutional review board approval, data on the first 25 patients who underwent single-site robotic cholecystectomies (SSRC) at our center. Patients enrolled in this study underwent SSRC for symptomatic biliary gallstones or polyposis. Exclusion criteria were: BMI[33; acute cholecystitis; previous upper abdominal surgery; ASA[II; and age[80 and\18 years. All procedures were performed with the da VinciSi Surgical System and a dedicated SSRC kit (Intuitive). After discharge, patients were followed for 2 months. These SSRC cases were compared to our first 25 single-incision laparoscopic cholecystectomies (SILC) and with the literature.

RESULTS:There were no differences in patient characteristics between groups (gender, P = 0.4404; age, P = 0.7423; BMI, P = 0.5699), and there were no conversions or major complications in either cohort. Operative time was significantly longer for the SILC group compared with SSRC (83.2 vs. 62.7 min, P = 0.0006), and SSRC operative times did not change significantly along the series. The majority of patients in each group were discharged within 24 h, with an average length of hospital stay of 1.2 days for the SILC group and 1.1 days for the SSRC group (P = 0.2854). No wound complications (infection, incisional hernia) were observed in the SSRC group and in the SILC.

CONCLUSIONS: Our preliminary experience shows that SSRC is safe, can easily be learned, and performed in a reproducible manner and is faster than SILC.

2. Kroh M, El-Hayek K, Rosenblatt S, Chand B, Escobar P, Kaouk J, Chalikonda S. First human surgery with a novel single-port robotic system: cholecystectomy using the da Vinci Single-Site platform. Surg Endosc. 2011 Nov;25(11):3566-73. Epub 2011 Jun 3.

OBJECTIVE: To compare the functional results of two contemporary series of patients with clinically localized prostate cancer treated by robot-assisted laparoscopic prostatectomy (RALP) or retropubic radical prostatectomy (RRP).

PATIENTS AND METHODS: This was a non-randomized prospective comparative study of all patients undergoing RALP or RRP for clinically localized prostate cancer at our institution from February 2006 to April 2007.

RESULTS: We enrolled 105 patients in the RRP and 103 in the RALP group; the two groups were comparable for all clinical and pathological variables, except median age. For RRP and RALP the respective median operative duration was 135 and 185 min (P < 0.001), the intraoperative blood loss 500 and 300 mL (P < 0.001) and postoperative transfusion rates 14% and 1.9% (P < 0.01). There were complications in 9.7% and 10.4% of the patients (P = 0.854) after RRP and RALP, respectively; the positive surgical margin rates in pT2 cancers were 12.2% and 11.7% (P = 0.70). For urinary continence, 41% of patients having RRP and 68.9% of those having RALP were continent at catheter removal (P < 0.001). The 12-month continence rates were 88% after RRP and 97% after RALP (P = 0.01), with the mean time to continence being 75 and 25 days (P < 0.001), respectively. At the 12-month follow-up, 20 of 41 patients having bilateral nerve-sparing RRP (49%) and 52 of 64 having bilateral nerve-sparing RALP (81%) (P < 0.001) had recovery of erectile function.

CONCLUSIONS: RALP offers better results than RRP in terms of urinary continence and erectile function recovery, with similar positive surgical margin rates.

3. Haber GP, White MA, Autorino R, Escobar PF, Kroh MD, Chalikonda S, Khanna R, Forest S, Yang B, Altunrende F, Stein RJ, Kaouk JH. Novel robotic da Vinci instruments for laparoendoscopic single-site surgery. Urology. 2010 Dec;76(6):1279-82. Epub 2010 Oct 27.

PURPOSE: To critically review perioperative outcomes, positive surgical margin (PSM) rates, and functional outcomes of several large series of retropubic radical prostatectomy (RRP), laparoscopic RP (LRP), and robot-assisted radical prostatectomy (RARP) currently available in the literature.

METHODS: A Medline database search was performed from November 1994 to May 2009, using medical subject heading search terms "prostatectomy" and "Outcome Assessment (Health Care)" and text words "retropubic," "robotic," and "laparoscopic." Only studies with a sample size of 250 or more patients were considered. Weighted means were calculated for all outcomes using the number of patients included in each study as the weighing factor.

RESULTS: We identified 30 articles for RRP, 14 for LRP, and 14 for RARP. The mean intraoperative and postoperative RRP transfusion rates for RRP, LRP, and RARP were 20.1%, 3.5%, and 1.4%, respectively. The weighted mean postoperative complication rates for RRP, LRP, and RARP were 10.3% (4.8% to 26.9%), 10.98% (8.9 to 27.7%), and 10.3% (4.3% to 15.7%), respectively. RARP revealed a mean overall PSM rate of 13.6%, whereas LRP and RRP yielded a PSM of 21.3% and 24%, respectively. The weighted mean continence rates at 12 month follow-up for RRP, LRP, and RARP were 79%, 84.8%, and 92%, respectively. The weighted mean potency rates for patients who underwent unilateral or bilateral nerve sparing, at 12 month follow-up, were 43.1% and 60.6% for RRP, 31.1% and 54% for LRP, and 59.9% and 93.5% for RARP.

CONCLUSIONS: RRP, LRP, and RARP performed in high-volume centers are safe options for treatment of patients with localized prostate cancer, presenting similar overall complication rates. LRP and RARP, however, are associated with decreased operative blood loss and decreased risk of transfusion when compared with RRP. Our analysis including high-volume centers also showed lower weighted mean PSM rates and higher continence and potency rates after RARP compared with RRP and LRP. However, the lack of randomized trials precludes definitive conclusions.

4. Wren SM, Curet MJ. Single-port robotic cholecystectomy: results from a first human use clinical study of the new da Vinci single-site surgical platform. Arch Surg. 2011 Oct;146(10):1122-7. Epub 2011 Jun 20.

PURPOSE: Robot assisted partial nephrectomy is rapidly emerging as an alternative to laparoscopic partial nephrectomy for the treatment of renal malignancy. We present the largest multi-institution comparison of the 2 approaches to date, describing outcomes from 3 experienced minimally invasive surgeons.

MATERIALS AND METHODS: We performed a retrospective chart review, evaluating 118 consecutive laparoscopic partial nephrectomies and 129 consecutive robot assisted partial nephrectomies performed between 2004 and 2008 by 3 experienced minimally invasive surgeons at 3 academic centers. Perioperative data were recorded along with clinical and pathological outcomes.

RESULTS: The robot assisted and laparoscopic partial nephrectomy groups were equivalent in terms of age, gender, body mass index, American Society of Anesthesiologists classification (2.3 vs 2.4) and radiographic tumor size (2.9 vs 2.6 cm), respectively. Comparison of operative data revealed no significant differences in terms of overall operative time (189 vs 174 minutes), collecting system entry (47% vs 54%), pathological tumor size (2.8 vs 2.5 cm) and positive margin rate (3.9% vs 1%) for robot assisted and laparoscopic partial nephrectomy, respectively. Intraoperative blood loss was less for robot assisted vs laparoscopic partial nephrectomy (155 vs 196 ml, p = 0.03) as was length of hospital stay (2.4 vs 2.7 days, p <0.0001). warm="" ischemia="" times="" were="" significantly="" shorter="" in="" the="" robot="" assisted="" partial="" nephrectomy="" series="" 19="" 7="" vs="" 28="" 4="" minutes="" p="" 0="" 0001="" subset="" analysis="" based="" on="" complexity="" revealed="" that="" tumor="" had="" no="" effect="" operative="" time="" or="" estimated="" blood="" loss="" for="" although="" did="" affect="" these="" factors="" laparoscopic="" addition="" simple="" and="" complex="" tumors="" provided="" ischemic="" than="" 15="" 3="" 25="" 2="" 9="" 36="" there="" intraoperative="" complications="" during="" 1="" complication="" postoperative="" rates="" similar="" 8="" 6="" 10="">

CONCLUSIONS: Robot assisted partial nephrectomy is a safe and viable alternative to laparoscopic partial nephrectomy, providing equivalent early oncological outcomes and comparable morbidity to a traditional laparoscopic approach. Moreover robot assisted partial nephrectomy appears to offer the advantages of decreased hospital stay as well as significantly less intraoperative blood loss and shorter warm ischemia time, the latter of which may help to provide maximal preservation of renal reserve. In addition, operative parameters for robot assisted partial nephrectomy appear to be less affected by tumor complexity compared to laparoscopic partial nephrectomy. Interestingly while the advantages of robotic surgery have historically been believed to aid laparoscopic naïve surgeons, these data indicate that robot assisted partial nephrectomy may also benefit experienced laparoscopic surgeons.

Clinical Research for da Vinci Surgeons & Hospitals

da Vinci surgeons and hospital staff can perform detailed research from the world's largest collection of robotic-assisted surgery abstracts on the da Vinci Surgery Online Community: www.daVinciSurgeryCommunity.com.

Reserved exclusively for da Vinci practitioners and personnel, this site is free but requires registration. Access to the Clinical Research section of the site requires validation, which may take up to two business days.

Sign up now to access the da Vinci Surgery database.

To determine whether the US FDA has cleared da Vinci Surgical System for use in a specific procedure, please refer to Intuitive Surgical’s Regulatory Clearance page.

As with any surgery, these benefits cannot be guaranteed since surgery is specific to each patient, condition and procedure. This information can help you make the best decision for your situation.

All surgery presents risk, including da Vinci Surgery. Results, including cosmetic results, may vary. Serious complications may occur in any surgery, up to and including death. Examples of serious and life-threatening complications, which may require hospitalization, include injury to tissues or organs; bleeding; infection, and internal scarring that can cause long-lasting dysfunction or pain. Temporary pain or nerve injury has been linked to the inverted position often used during abdominal and pelvic surgery. Patients should understand that risks of surgery include potential for human error and potential for equipment failure. Risk specific to minimally invasive surgery may include: a longer operative time; the need to convert the procedure to an open approach; or the need for additional or larger incision sites. Converting the procedure to open could mean a longer operative time, long time under anesthesia, and could lead to increased complications. Research suggests that there may be an increased risk of incision-site hernia with single-incision surgery. Patients who bleed easily, have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci Surgery. Other surgical approaches are available. Patients should review the risks associated with all surgical approaches. They should talk to their doctors about their surgical experience and to decide if da Vinci is right for them. For more complete information on surgical risks, safety and indications for use, please refer to http://www.davincisurgery.com/da-vinci-surgery/safety-information.php.

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PN 876249 Rev A 08/12 U 10/25/2012

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