Gynecology Clinical Evidence
Significant Publications
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 what are called “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 selected bibliography of clinical publications on da Vinci gynecologic surgery.
- Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008;15(3):286-91.View abstract
Abstract
STUDY OBJECTIVE: To compare gynecologic practice and perioperative outcomes of patients undergoing total laparoscopic hysterectomy and robotic hysterectomy before and after implementation of a robotics program.
DESIGN: A retrospective chart review of the last 200 consecutive hysterectomy cases completed before and after implementation of a robotics program (Canadian Task Force classification III).
SETTING: Community hospital.
PATIENTS: All patients requiring hysterectomy for benign indications between November 2004 and January 2007.
INTERVENTIONS: Patients were candidates for total laparoscopic, abdominal, or vaginal hysterectomy before February 2006 and were candidates for total laparoscopic, total abdominal, total vaginal, or robotic-assisted laparoscopic hysterectomy after February 2006. Perioperative characteristics and trends were studied.
MEASUREMENTS AND MAIN RESULTS: In all, 100 patients intended to be treated by laparoscopic hysterectomy before the implementation of a robotics program were compared with 100 patients treated by robotic hysterectomy after robot implementation. Overall the robotic cohort experienced longer operative times by an average of 27 minutes. The prerobotic cohort, however, when compared with the last 25 robotic cases had longer operative times (92.4 minutes [29.2], 95% CI 46.0-225.0 vs 78.7 minutes [29.5], 95% CI 66.0-91.2, p = .03). The mean blood loss in the prerobotic cohort was twice that of the robotic cohort (113 mL [85.9], 95% CI 95.9-130.1 vs 61.1 mL [60.9], 95% CI 48.9-73.2, p <.0001) and the mean length of hospital stay was half a day longer in the prerobotic cohort than in the robotic cohort (1.6 days [1.4], 95% CI 1.3-1.9 vs 1.1 days [0.7], 95% CI 1.0-1.3, p <.007). The incidence of adverse events was the same in both groups. The total number of exploratory laparotomies in the prerobotic cohort was significantly greater than in the robotic group (11% vs 0%). The rate of intraoperative conversions to total abdominal hysterectomy from laparoscopy was approximately 2-fold higher in the prerobotic cohort as compared with the robotic cohort (9% vs 4%).
CONCLUSIONS: A higher likelihood of exploratory laparotomy for hysterectomy in the prerobotic cohort versus the robotic cohort and a higher likelihood of intraoperative conversion to laparotomy with the prerobotic cohort than with the robotic cohort existed. Reduced operative time, reduced blood loss, and shortened length of stay may be achieved in patients who are treated robotically versus a nonrobotic approach. Robotics may facilitate the minimally invasive treatment of patients while potentially reducing the rate of abdominal hysterectomies.
- Payne TN, Dauterive FR, Pitter MC, Giep HN, Giep BN, Grogg TW, Shanbour KA, Goff DW, Hubert HB. Robotically assisted hysterectomy in patients with large uteri: outcomes in five community practices. Obstet Gynecol. 2010 Mar;115(3):535-42. doi: 10.1097/AOG.0b013e3181cf45ad.View abstract
Abstract
OBJECTIVE: To examine outcomes of robotically assisted laparoscopic hysterectomy in patients with benign conditions involving high uterine weight and complex pathology.
METHODS: A multicenter study was undertaken in five community practice settings across the United States. All patients who had minimally invasive laparoscopic hysterectomy with robotic assistance March 2006 through July 2009 and uterine weights of at least 250 g were included. Retrospective chart review identified outcomes including skin-to-skin operative time, conversion to an exploratory laparotomy, blood loss, complications, and hospital duration of stay. The effect of uterine weight on skin-to-skin time and blood loss also was examined.
RESULTS: Data were analyzed for 256 patients with uteri weighing 250 to 3,020 g (median 453 g). Most patients were obese or had a history of pelvic or abdominal surgery. Median operative time was 145 minutes. Duration of surgery in patients with uteri 500 g or greater was significantly longer than in patients with uteri less than 500 g (167 compared with 126 minutes, P<.001). Median estimated blood loss also was greater in women with uteri weighing 500 g or more (100 compared with 50 mL, P<.001). Multivariable linear regression analysis confirmed the independent effect of uterine weight on operative time and blood loss. Median duration of hospital stay was 1 day. The conversion rate was 1.6%, the minor complication rate was 1.6%, and major complications occurred in 2.0% of patients.
CONCLUSIONS: Women with large uteri may successfully undergo robotically assisted hysterectomy with low morbidity, low blood loss, and minimal risk of conversion to laparotomy. Results were reproducible among general gynecologists from geographically diverse community settings.
- Lau S, Vaknin Z, Ramana-Kumar AV, Halliday D, Franco EL, Gotlieb WH. Outcomes and cost comparisons after introducing a robotics program for endometrial cancer surgery. Obstet Gynecol. 2012 Apr;119(4):717-24. doi: 10.1097/AOG.0b013e31824c0956. View abstract
Abstract
BACKGROUND: To evaluate the effect of introducing a robotic program on cost and patient outcome. METHODS: This was a prospective evaluation of clinical outcome and cost after introducing a robotics program for the treatment of endometrial cancer and a retrospective comparison to the entire historical cohort.
RESULTS: Consecutive patients with endometrial cancer who underwent robotic surgery (n=143) were compared with all consecutive patients who underwent surgery (n=160) before robotics. The rate of minimally invasive surgery increased from 17% performed by laparoscopy to 98% performed by robotics in 2 years. The patient characteristics were comparable in both eras, except for a higher body mass index in the robotics era (median 29.8 compared with 27.6; P<.005). Patients undergoing robotics had longer operating times (233 compared with 206 minutes), but fewer adverse events (13% compared with 42%; P<.001), lower estimated median blood loss (50 compared with 200 mL; P<.001), and shorter median hospital stay (1 compared with 5 days; P<.001). The overall hospital costs were significantly lower for robotics compared with the historical group (Can$7,644 compared with Can$10,368 [Canadian dollars]; P<.001) even when acquisition and maintenance cost were included (Can$8,370 compared with Can$10,368; P=.001). Within 2 years after surgery, the short-term recurrence rate appeared lower in the robotics group compared with the historic cohort (11 recurrences compared with 19 recurrences; P<.001).
CONCLUSIONS: Introduction of robotics for endometrial cancer surgery increased the proportion of patients benefitting from minimally invasive surgery, improved short-term outcomes, and resulted in lower hospital costs. LEVEL OF EVIDENCE: II.
- Boggess JF, Gehrig PA, Cantrell L, Shafer A, Ridgway M, Skinner EN, Fowler WC. A comparative study of 3 surgical methods for hysterectomy with staging for endometrial cancer: robotic assistance, laparoscopy, laparotomy. Am J Obstet Gynecol. 2008 Oct;199(4):360.e1-9. View abstract
Abstract
BACKGROUND: The purpose of this study was to compare outcomes in women who underwent endometrial cancer staging by different surgical techniques.
STUDY DESIGN: Three hundred twenty-two women underwent endometrial cancer staging: 138 by laparotomy (TAH); 81 by laparoscopy (TLH) and 103 by robotic technique (TRH).
RESULTS: The TRH cohort had a higher body mass index than the TLH cohort (P = .0008). Lymph node yield was highest for TRH (P <.0001); hospital stay (P <.0001) and estimated blood loss (P <.0001) were lowest for this cohort. Operative time was longest for TLH (213.4 minutes) followed by TRH (191.2 minutes) and TAH (146.5 minutes; P <.0001. Postoperative complication rates were lower for TRH, compared with TAH (5.9% vs 29.7%; P <.0001). Conversion rates for the robotic and laparoscopic groups were similar.
CONCLUSIONS: TRH with staging is feasible and preferable over TAH and may be preferable over TLH in women with endometrial cancer. Further study is necessary to determine long-term oncologic outcomes.
- Scandola M, Grespan L, Vicentini M, Fiorini P. Robot-Assisted Laparoscopic Hysterectomy vs Traditional Laparoscopic Hysterectomy: Five Metaanalyses. J Minim Invasive Gynecol. 2011 Nov-Dec;18(6):705-15. View abstract
Abstract
To assess differences between laparoscopic hysterectomy performed with or without robot-assistance, we performed metaanalyses of 5 key indices strongly associated with societal and hospital costs, patient safety, and intervention quality. The 5 indexes included estimated blood loss (EBL), operative time, number of conversions to laparotomy, hospital length of stay (LOS), and number of postoperative complications. A search of PubMed, Medline, Embase, and Science citation index online databases yielded a total of 605 studies. After a systematic review, we proceeded with meta-analysis of 14 articles for EBL, with a summary effect of -0.61 (95% confidence interval [CI], -42.42 to 46.20); 20 for operative time, with a summary effect of 0.66 (95% CI, -15.72 to 17.04); 17 for LOS, with a summary effect of -0.43 (95% CI, -0.68 to -0.17); 15 for conversion to laparotomy (odds ratio, 0.50; 95% CI, 0.31 to 0.79 with a random model); and 14 for postoperative complications (odds ratio, 0.69; 95% CI, 0.43 to 1.09 with a random model). In conclusion, compared with traditional laparoscopic hysterectomy, robot-assisted laparoscopic hysterectomy was associated with shorter LOS and fewer postoperative complications and conversions to laparotomy; there were no differences in EBL and operative time. These results confirm that robot-assisted laparoscopy has less deletorious effect on hospital, society, and patient stress and leads to better intervention quality.
- Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. Robotic-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes. Obstet Gynecol. 2011 Feb;117(2 Pt 1):256-65. View abstract
Abstract
BACKGROUND: To compare the surgical outcomes of robot-assisted laparoscopic myomectomy (robot-assisted), standard laparoscopic myomectomy (laparoscopic), and open myomectomy (abdominal).
METHODS: Myomectomy patients were identified from the case records of the Cleveland Clinic and stratified into three groups. Operative and immediate postoperative outcomes were compared. Data analysis was performed using analysis of variance, Kruskal-Wallis analysis of ranks, χ2, and Fisher exact tests where appropriate.
RESULTS: From a total of 575 myomectomies, 393 (68.3%) were abdominal, 93 (16.2%) were laparoscopic, and 89 (15.5%) were robot-assisted. The three groups were comparable regarding the size, number, and location. Significantly heavier myomas were removed in the robot-assisted group (223 [85.25, 391.50] g) compared with the laparoscopic group (96.65 [49.50, 227.25] g, P<.001) and were lower than in the abdominal group (263 [ 90.50, 449.00] g, P=.002). Higher blood loss was reported in the abdominal group compared with the other two groups, with a median (interquartile range) of blood loss in milliliters of 100 (50, 212.50), 200 (100, 437.50) and 150 (100, 200) in the laparoscopic, abdominal, and robot-assisted groups, respectively. The actual surgical time in minutes was 126 (95, 177) in the abdominal group, 155 (98, 200) in the laparoscopic group, and 181 (151, 265) in robot-assisted group (P<.001). Patients in the abdominal group had a higher median length of hospital stay of 3 (2, 3) days, compared with 1 (0, 1) day in the laparoscopic group and 1 (1, 1) days in the robot-assisted group (P<.001).
CONCLUSIONS: Robotic-assisted myomectomy is associated with decreased blood loss and length of hospital stay compared with traditional laparoscopy and to open myomectomy. Robotic technology could improve the utilization of the laparoscopic approach for the surgical management of symptomatic myomas.
- Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 Feb 1. View abstract
Abstract
BACKGROUND: The purpose of this study was to compare symptomatic and anatomic outcomes 1 year after robotic vs abdominal sacrocolpopexy.
STUDY DESIGN: Our retrospective cohort study compared women who underwent robotic sacrocolpopexy (RSC) with 1 surgeon to those who underwent abdominal sacrocolpopexy (ASC) as part of the Colpopexy and Urinary Reduction Efforts trial. Our primary outcome was a composite measure of vaginal bulge symptoms or repeat surgery for prolapse.
RESULTS: We studied 447 women (125 with RSC and 322 with ASC). Baseline characteristics were similar. There were no significant differences in surgical failures 1 year after surgery based on our primary composite outcome (7/86 [8%] vs 12/304 [4%]; P = .16). When we considered anatomic failure, there were also no significant differences between RSC and ASC (4/70 [6%] vs 16/289 [6%]; P = .57).
CONCLUSIONS: One year after sacrocolpopexy, women who underwent RSC have similar symptomatic and anatomic success compared with those women who underwent ASC.
- Hoyte L, Rabbanifard R, Mezzich J, Bassaly R, Downes K. Cost analysis of open versus robotic-assisted sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2012 Nov-Dec;18(6):335-9. doi: 10.1097/SPV.0b013e318270ade3. View abstract
Abstract
OBJECTIVE: This study aimed to report on the costs, operative times, and length of stay for robotic and open sacrocolpopexy.
STUDY DESIGN: This retrospective study compares consecutive open and robotic sacrocolpopexies that were performed beyond the surgical learning curve. Hospital direct costs, operative times, and length of stay were compared for the 2 groups. Robot cost and maintenance were included. Statistical significance was considered at P < 0.05.
RESULTS: The study comprised 91 open and 73 robotic sacrocolpopexies. Both groups were similar clinically. Median operative times for open and robotic approaches were 166 and 212 minutes (P < 0.001), respectively, and length of stay was 3 versus 2 days (P < 0.001). Of the women in the robotic group, 48% had length of stay less than 24 hours versus 1% in the open group. Median robotic and open procedure direct costs were $6668 and $7804 (P = 0.002), respectively. Readmission rates at 30 days postoperatively were similar.
CONCLUSIONS: Robotic sacrocolpopexy costs less but takes slightly longer to perform than the open procedure.
- Dulemba JF, Pelzel C, Hubert H. Retrospective analysis of robot-assisted versus standard laparoscopy in the treatment of pelvic pain indicative of endometriosis. J Robotic Surg DOI 10.1007/s11701-012-0361-4. View abstract
Abstract
OBJECTIVE: We examined the feasibility of treating pelvic pain in patients with suspected endometriosis using robot-assisted laparoscopic techniques compared with CO2laser laparoscopy, in a retrospective review from a single surgeon’s practice, including the last 100 standard laparoscopic (December 2004–September 2007) and the first 180 robot-assisted (July 2007–January 2010) surgeries to treat suspected endometriosis. Perioperative outcomes and postoperative pain were compared by technique. Patients in each group were comparable in gravidity, body mass index, prior endometriosis, prior abdominopelvic surgery, American Fertility Society stage, and biopsy rates.
RESULTS: Operative time (77 vs. 72 min), blood loss (29 vs. 25 mL), and complication rates (1.1 vs. 0 %) in robot-assisted and standard laparoscopy were low and similar for both approaches. Differences were apparent in biopsies confirming endometriosis (80 % robot-assisted vs. 56.8 % traditional laparoscopy, p\0.001). Most patients reported improved postoperative pain at the first follow-up visit with no differences between the surgical approaches (85 % vs.80 %, p=0.365). Perioperative outcomes with robot-assisted surgery were comparable to outcomes using CO2 laser laparoscopy. Further investigation is needed to ascertain whether robotics provides better visual acuity and excision of endometriosis, as suggested by these data, and if long-term resolution of symptoms and fertility outcomes differ by surgical approach.
Clinical Research for
da Vinci Surgeons & Personnel
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