General Surgery Clinical Evidence
Many people want to know how new technologies can impact their health. One of the ways to find out about the pros and cons of medicine, medical devices, and surgical techniques is to review peer-reviewed clinical publications. These publications report on studies that examine whether a treatment is safe, appropriate and effective.
Our clinical library contains thousands of publications and is growing at a rate of approximately 100 publications per month. The vast majority are researched and written independently of Intuitive Surgical, Inc. Below is a clinical bibliography of featured publications representing da Vinci General Surgery.
- 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. View abstract
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="" vinci="" si="" surgical="" system="" and="" a="" dedicated="" ssrc="" kit="" intuitive="" after="" discharge="" patients="" followed="" for="" 2="" months="" these="" cases="" compared="" to="" our="" first="" 25="" single-incision="" laparoscopic="" cholecystectomies="" silc="" literature="" p="">
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.
- Baik SH, Kwon HY, Kim JS, Hur H, Sohn SK, Cho CH, Kim H. Robotic versus laparoscopic low anterior resection of rectal cancer: short-term outcome of a prospective comparative study. Ann Surg Oncol. 2009 Jun;16(6):1480-7. Epub 2009 Mar 17. View abstract
PURPOSE:The aim of this study is to compare the short-term results between robotic-assisted low anterior resection (R-LAR), using the da Vinci Surgical System, and standard laparoscopic low anterior resection (L-LAR) in rectal cancer patients.
METHODS:113 patients were assigned to receive either R-LAR (n = 56) or L-LAR (n = 57) between April 2006 and September 2007. Patient characteristics, perioperative clinical results, complications, and pathologic details were compared between the groups. Moreover, macroscopic grading of the specimen was evaluated.
RESULTS: Patient characteristics were not significantly different between the groups. The mean operation time was 190.1 +/- 45.0 min in the R-LAR group and 191.1 +/- 65.3 min in the L-LAR group (P = 0.924). The conversion rate was 0.0% in the R-LAR groups and 10.5% in the L-LAR group (P = 0.013). The serious complication rate was 5.4% in the R-LAR group and 19.3% in the L-LAR group (P = 0.025). The specimen quality was acceptable in both groups. However, the mesorectal grade was complete (n = 52) and nearly complete (n = 4) in the R-LAR group and complete (n = 43), nearly complete (n = 12), and incomplete (n = 2) in the L-LAR group (P = 0.033).
CONCLUSIONS: R-LAR was performed safely and effectively, using the da Vinci Surgical System. The use of the system resulted in acceptable perioperative outcomes compared to L-LAR.
- deSouza AL, Prasad LM, Ricci J, Park JJ, Marecik SJ, Zimmern A, Blumetti J, Abcarian H. A comparison of open and robotic total mesorectal excision for rectal adenocarcinoma. Dis Colon Rectum. 2011 Mar;54(3):275-82. View abstract
PURPOSE:This retrospective study was designed to compare open with robot-assisted total mesorectal excision for rectal adenocarcinoma.
METHODS: With use of predefined exclusion criteria, all consecutive laparoscopic-assisted (51 patients) and robot-assisted (36 patients) rectal resections for adenocarcinoma from August 2005 to November 2009 at a single institution were considered. Hand-assisted laparoscopy was used for splenic flexure mobilization in all cases. Patients were assigned into robotic and open groups on the basis of the technique used for total mesorectal excision. All 36 robot-assisted resections had the total mesorectal excision performed with robotic assistance and were included in the robotic group. Forty-six of the 51 patients who received a laparoscopic-assisted procedure had the total mesorectal excision performed through the hand port using open surgical technique and were included in the open group. Both groups were compared with respect to patient demographics, perioperative outcomes, and pathology.
RESULTS: The robotic and open groups were comparable in age, sex, body mass index, history of prior abdominal surgery, ASA class, number of patients receiving neoadjuvant chemoradiation, and tumor stage. There were more abdominoperineal resections (P = .019) and more low and mid rectal tumors (P = .007) in the robotic group. Total procedure time was longer in the robotic group (P = .003), but blood loss was less (P = .036). Lymph node yield, intraoperative and postoperative complications, and length of stay were all comparable. There were 3 positive circumferential margins in the open group vs none in the robotic group, but this did not reach statistical significance.
CONCLUSIONS: Robotic total mesorectal excision is feasible and safe, and is comparable to open total mesorectal excision in terms of perioperative and pathological outcomes. The longer operative time associated with robotic total mesorectal excision could decrease as experience with this relatively new technique increases. Large randomized trials are necessary to validate the potential benefits of less blood loss and lower margin positivity rates observed in this study.
- Kim MC, Heo GU, Jung GJ. Robotic gastrectomy for gastric cancer: surgical techniques and clinical merits. Surg Endosc. 2010 Mar;24(3):610-5. Epub 2009 Aug 18. View abstract
PURPOSE:: To evaluate the protection of the urogenital function after robot-assisted total mesorectal excision (R-TME) for rectal cancer compared to those of laparoscopic TME (L-TME). METHODS: 69 patients who underwent L-TME (n = 39) or R-TME (n = 30) were prospectively enrolled. Their urogenital function was evaluated by uroflowmetry, a standard questionnaire of the international prostate symptom score (IPSS) and the international index of erectile function (IIEF) before surgery and 1, 3, 6, and 12 months after surgery. The pre- and postoperative IPSS and IIEF scores were compared to detect functional deterioration by paired t test for each group. How postoperative IPSS and IIEF scores and uroflowmetry data deviated from the preoperative values (Δ) were statistically compared between the two groups.
RESULTS: The IPSS score significantly increased 1 month after surgery; the recovery from decreased urinary function took 6 months for patients in the L-TME group (8.2 ± 6.3; P = 0.908) but 3 months in the R-TME group (8.36 ± 5.5; P = 0.075). The ΔIPSS scores were significantly different between the two groups at 3 months (P = 0.036). In male patients (L-TME 20, R-TME 18), the total IIEF score in R-TME and L-TME significantly decreased 1 month after surgery, L-TME gradually recovered over 12 months (46.00 ± 16.9; P = 0.269), but R-TME recovered within 6 months (44.61 ± 13.76; P = 0.067). The ΔIIEF score value was not significantly different at any time between the two groups, but in an itemized analysis of the change in erectile function and sexual desire, there were significant differences at 3 months between the two groups.
CONCLUSIONS: R-TME for rectal cancer is associated with earlier recovery of normal voiding and sexual function compared to patients who underwent L-TME, although this result needs to be verified by larger prospective comparative studies.
- Snyder BE, Wilson T, Leong BY, Klein C, Wilson EB. Robotic-assisted Roux-en-Y Gastric bypass: minimizing morbidity and mortality. Obes Surg. 2010 Mar;20(3):265-70. Epub 2009 Nov 3. View abstract
BACKGROUND: Despite the rapid acceptance of laparoscopic Roux-en-Y gastric bypass (RYGB) by the community and increase in the number of these procedures being done, there is still significant morbidity and mortality.
METHODS: At the University of Texas Medical School at Houston, we have performed 320 RYGB with robotic assistance (RARYGB). Surgical times, length of stay, morbidity, and mortality have been recorded since the beginning of our robotic experience and represent the world's largest single institution series of RARYGB. Outcome data were examined in a postoperative cohort.
RESULTS: The average starting BMI was 49.1 kg/m(2), and it declined by 66% to 32.5 kg/m(2) by the end of 1 year. The average operative time was 192 min, and the average length of stay was 2.7 days. Within the first year, there were a total of 77 (24.1%) complications. The foremost complications noted in the literature to be 3% to 11% were all <1% in our series, and we have no mortalities. Compared to our 356 laparoscopic RYGB, there was a significantly lower gastrointestinal leak rate in the robotic arm. A cohort of 79 postoperative patients was analyzed with respect to weight loss, resolution of co-morbidity, and quality of life. While there was no variation in quality of life over time, weight loss, resolution of co-morbidities, and overall outcome score were significantly improved.
CONCLUSIONS: We effectively perform robotic-assisted RYGB that lowers the morbidity and mortality of this procedure compared to today's standard while maintaining thriving outcomes.
- Chalikonda S, Aguilar-Saavedra JR, Walsh RM. Laparoscopic robotic-assisted pancreaticoduodenectomy: a case-matched comparison with open resection. Surg Endosc. 2012 Mar 22. [Epub ahead of print] View abstract
BACKGROUND: Minimally invasive procedures have expanded recently to include pancreaticoduodenectomy (PD), but the efficacy of a laparoscopic robotic-assisted approach has not been demonstrated. A case-matched comparison was undertaken to study outcomes between laparoscopic robotic approach (LRPD) and the conventional open counterpart (OPD).
METHODS: From March 2009 through December 2010, 30 LRPD were performed by two pancreaticobiliary surgeons at the Cleveland Clinic. Thirty OPD patients operated by four pancreaticobiliary surgeons during this same period were matched by demographics, and postoperative outcomes were compared from review of a prospectively collected database.
RESULTS: Mean age was 62 years for LRPD versus 61 years for OPD (p = 0.43). Mean body mass index was 24.8 versus 25.6 kg/m(2) (p = 0.49). Surgical indications included adenocarcinoma in 14 patients from each group (46%), intraductal papillary mucinous neoplasm in 4 (14%), and other in 12 (40%). There was one preoperative death in the LRPD group and none following OPD. Morbidity occurred in nine patients (30%) following LRPD versus 13 (44%) in the OPD group (p = 0.14). Intraoperative factors assessed included blood loss (485.8 vs 775 ml, p = 0.13) and operative time (476.2 vs 366.4 min, p = 0.0005). Conversion from LRPD to open occurred in three patients (12%) due to bleeding. Reoperation was performed in two patients (6%) following LRPD versus seven (24%) following OPD (p = 0.17). Length of hospital stay was 9.79 days for LRPD versus 13.26 days in the OPD group (p = 0.043).
CONCLUSIONS: This is the first comparison of a novel laparoscopic robotic-assisted PD with the open PD in a case-matched fashion. Our data demonstrate a significant increase in operative time but decreased length of stay for LRPD. The favorable morbidity following LRPD makes it a reasonable surgical approach for selected patients requiring PD.
Clinical Research for da Vinci Surgeons & Personnel
da Vinci surgeons and personnel can perform detailed research from the world's largest collection of robotically-assisted surgery abstracts on the da Vinci Surgery Online Community: www.davinciSurgeryCommunity.com.
This site is open to da Vinci practitioners and personnel only and requires free sign up. Access to the Clinical Research section of the site requires validation, which can take 1-2 business days.
To determine whether the FDA has cleared da Vinci Surgical System for use in a specific procedure, please refer to the Regulatory Clearance page.
PN 873870 Rev B 07/12
Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Risks of surgery also include the potential for equipment failure and/or human error. Individual surgical results may vary.
Risks specific to minimally invasive surgery, including da Vinci Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; temporary pain/discomfort from the use of air or gas in the procedure; a longer operation and time under anesthesia and conversion to another surgical technique. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications.
Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci Surgery. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models.
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