Gynecology Clinical Evidence
Featured Publications
The below are featured publications that support the clinical efficacy of da Vinci® Gynecologic Surgery.
- 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. 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.
- 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
OBJECTIVE: 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.
- Ascher-Walsh CJ, Capes TL. Robot-assisted laparoscopic myomectomy is an improvement over laparotomy in women with a limited number of myomas. J Minim Invasive Gynecol. 2010 May Jun; 17(3):306-10. Epub 2010 Mar 19.
View abstract.
Abstract
STUDY OBJECTIVE: To compare surgical and immediate postoperative results of robot-assisted laparoscopic myomectomy vs myomectomy via laparotomy in patients with 3 myomas or fewer.
DESIGN: Case-control (Canadian Task Force classification II-2).
SETTING: University hospital.
PATIENTS: Seventy-five women who had undergone robotic-assisted laparoscopic myomectomy were compared with patients who had undergone myomectomy via laparotomy.
INTERVENTIONS: Medical records were reviewed for surgical and postoperative variables. Both groups had 3 myomas or fewer confirmed at preoperative magnetic resonance imaging or final pathology report.
MEASUREMENTS AND MAIN RESULTS: No significant differences were observed between patients insofar as preoperative demographic data. There was a significant increase in mean duration of surgery for robotic-assisted myomectomy. There was a significant decrease in blood loss, change in hematocrit concentration on postoperative day 1, length of stay, number of days to regular diet, and febrile morbidity in robotic-assisted myomectomies. There were no significant differences in operative or postoperative complications.
CONCLUSIONS: Although robotic-assisted myomectomy took substantially longer, most of the other variables improved in comparison with similar procedures performed via laparotomy. Copyright 2010 AAGL. Published by Elsevier Inc. All rights reserved.
- Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-6.
View abstract.
Abstract
OBJECTIVE:To compare short-term outcomes of robotic sacrocolpopexy with abdominal sacrocolpopexy for vaginal vault prolapse.
METHODS: We conducted a retrospective cohort study comparing robotic to abdominal sacrocolpopexy with placement of permanent mesh. The primary outcome was vaginal vault support on 6-week postoperative pelvic organ prolapse quantification (POP-Q) system examination. Secondary outcomes included blood loss, operative time, length of stay, blood transfusion, pulmonary embolus, gastrointestinal or genitourinary tract injury, ileus, bowel obstruction, postoperative fever, pneumonia, wound infection, and urinary retention.
RESULTS: The analysis included 178 patients (73 robotic and 105 abdominal sacrocolpopexy). There were no differences in age, race, or body mass index. Robotic sacrocolpopexy showed slight improvement on POP-Q "C" point (-9 compared with -8, P=.008) when compared with abdominal sacrocolpopexy and was associated with less blood loss (103+/-96 mL compared with 255+/-155 mL, P<.001), longer total operative time (328+/-55 minutes compared with 225+/-61 minutes, P<.001), shorter length of stay (1.3+/-0.8 days compared with 2.7+/-1.4 days, P<.001), and a higher incidence of postoperative fever (4.1% compared with 0.0%, P=.04). There were no differences in other secondary outcomes. Operative time remained significantly greater in the robotic group (P<.001), and estimated blood loss remained lower (P<.001) when controlling for possible confounders.
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.
- Brudie LA, Gaia G, Ahmad S, Finkler NJ, Bigsby IV GE, Ghurani GB, Kendrick IV JE, Rakowski JA, Groton JH, Holloway RW. Peri-operative outcomes of patients with stage IV endometriosis undergoing robotic-assisted laparoscopic surgery. Received: 1 Aug 2011/Accepted: 10 September 2011. J Robotic Surg DOI 10.1007/s11701-011-0314-3.
View abstract.
Abstract
We analyzed peri-operative outcomes of 80 patients who underwent robotic-assisted laparoscopic surgery and were diagnosed with stage IV endometriosis (revised American Society for Reproductive Medicine) between January 2007 and December 2010 at a tertiary gynecologic oncology referral center with a fellowship training program. Eligible women had a combination of one or more factors: pelvic mass, sub-acute or chronic pelvic pain, dysmenorrhea, dyspareunia, elevated serum CA-125, diagnosed with stage IV endometriosis at surgery with robotic-assisted gynecologic procedures using the da Vinci Surgical System. The mean age was 43.7 ± 7.0 years, body mass index 27.5 ± 7.4 kg/m2, and 23 (28.9%) patients had prior endometriosis surgery. Presenting symptoms included: chronic pelvic pain (48.8%), dysmenorrhea (40.3%), and dyspareunia (33.8%). Sixty-nine (86%) patients had pelvic masses (43 unilateral and 26 bilateral). Thirty-seven (46.3%) had elevated CA-125 levels (mean 97.9 ± 71.6 U/ml). Forty-eight (60%) underwent robotic-assisted laparoscopic hysterectomy (RALH)/bilateral salpingo-oophorectomy (BSO), 9 (11.3%) RALH/unilateral salpingo-oophorectomy (USO), 5 (6.3%) modified radical hysterectomy, and 10 (13%) USO or BSO only. Four (5%) had ovarian cystectomies with excision of endometriotic implants. Three (3.8%) underwent appendectomy and no patient required bowel resection. Four (5%) patients required conversion to laparotomy during the first 15 cases of this series [dense adhesions (3) and ureteral injury (1)]. Mean operative time was 115 ± 46 min, blood loss 88 ± 67 ml, and length of stay 1.0 ± 0.4 days. There were four (5%) complications (ureteral injury, cuff abscess, cuff hematoma, re-admission for nausea and vomiting secondary to narcotics) and no transfusions. One (1.3%) patient underwent a second surgery for pain (dyspareunia). Robotic-assisted surgery for stage IV endometriosis resulted in excellent pain relief, with few laparotomy conversions or complications during a robotic learning-curve experience.
Number of “Level of Evidence” Publications
The table below summarizes the clinical publications relating to da Vinci GynecologicSurgery that meet the higher level of evidence standard of level 1, 2a or 2b, as defined by guidelines from the Department of Public Health Services, King's College, London.
| LEVEL | DESCRIPTION |
New in April | Total |
| Level 1 | Randomized control trial |
1 |
1 |
| Level 2a | Non-randomized prospective study including a comparison cohort |
0 |
12 |
| Level 2b | Non-randomized retrospective study including a comparison cohort |
5 |
110 |
| Lower level publications: |
| Level 3 | Single cohort (non-comparison) studies |
4 |
437 |
| Level 4 | Case studies |
5 |
| Level 5 | Opinion publications |
7 |
| TOTAL | |
22 |
556 |
Clinical Research for da Vinci® Practitioners
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PN 8756434 Rev A 12/11