Clinical Evidence - Gynecology

Gynecology - Clinical Evidence

Publications referenced on this page were conducted on the da Vinci^® Si, da Vinci^® S, and da Vinci^® Standard systems. No publications are currently available for the da Vinci^® Xi system.

Featured Publications

The below are featured publications that support the clinical efficacy of da Vinci^® Gynecologic Surgery.

Cancer Hysterectomy (4)

2012 Geetha P and Nair M   "Laparoscopic, robotic and open method of radical hysterectomy for cervical cancer: A systematic review." Journal of Minimal Access Surgery 8(3): 67-73.   Online article access

2012 Lau S, Vaknin Z, Ramana-Kumar AV, Halliday D, Franco EL and Gotlieb WH "Outcomes and cost comparisons after introducing a robotics program for endometrial cancer surgery." Obstetrics and Gynecology 119(4): 717-24.   Online article access

2011 Paley PJ, Veljovich DS, Shah CA, Everett EN, Bondurant AE, Drescher CW and Peters Iii WA "Surgical outcomes in gynecologic oncology in the era of robotics: Analysis of first 1000 cases." American Journal of Obstetrics and Gynecology 204(6): 551.e1-551.e9.   Online article access

2010 Gaia G, Holloway RW, Santoro L, Ahmad S, Di Silverio E and Spinillo A "Robotic-assisted hysterectomy for endometrial cancer compared with traditional laparoscopic and laparotomy approaches: a systematic review." Obstetrics and Gynecology 116(6): 1422-31. Online article access

Benign Hysterectomy (4)

2013 Gala RB, Margulies R, Steinberg A, Murphy M, Lukban J, Jeppson P, Aschkenazi S, Olivera C, South M, Lowenstein L, Schaffer J, Balk EM and Sung V "A Systematic Review Of Robotic Surgery In Gynecology - Robotic Techniques Compared With Laparoscopy And Laparotomy." Journal of Minimally Invasive Gynecology.   Online article access

2013 Martino MA, Berger EA, McFetridge J, Shubella J, Wejkszner T, Kainz GF, Patriarco J, Thomas MB and Boulay R "Robotic surgery readmissions in patients having a hysterectomy for benign disease." Journal of Minimally Invasive Gynecology.   Online article access

2011 Scandola M, Grespan L, Vicentini M and Fiorini P "Robot-Assisted Laparoscopic Hysterectomy vs Traditional Laparoscopic Hysterectomy: Five Metaanalyses." Journal of Minimally Invasive Gynecology 18(6): 705-15.   Online article access

2010 Payne TN, Dauterive FR, Pitter MC, Giep HN, Giep BN, Grogg TW, Shanbour KA, Goff DW and Hubert HB "Robotically assisted hysterectomy in patients with large uteri: outcomes in five community practices." Obstetrics and Gynecology 115(3): 535-42.   Online article access

Endometriosis (1)

2013 Dulemba JF, Pelzel C and Hubert HB "Retrospective analysis of robot-assisted versus standard laparoscopy in the treatment of pelvic pain indicative of endometriosis." Journal of Robotic Surgery 7(2): 163-169.   Online article access

Myomectomy (2)

2013 Pitter MC, Gargiulo AR, Bonaventura LM, Stefano Lehman J and Srouji SS "Pregnancy outcomes following robot-assisted myomectomy." Human Reproduction 28(1): 99-108.   Online article access

2011 Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M and Falcone T "Robotic-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes." Obstetrics and Gynecology 117(2 Pt 1): 256-266   (Online article access)

Sacrocolpopexy (2)

2014 Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS, Lowenstein L and Gutman RE "Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study." Female Pelvic Med Reconstr Surg 20(1): 33-7.   Online article access

2012 Siddiqui NYG, E. J.; Visco, A. G. "Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy." American Journal of Obstetrics and Gynecology. 206(5): 435 e1-5   (Online article access)

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%) modi?ed 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 ?rst 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 Publications, by Level of Evidence

The table below summarizes the level of scientific evidence for the clinical publications related to da Vinci Gynecology Surgery. These levels of evidence are adapted from the March 2009 Centre for Evidence Based Medicine levels of evidence.

LEVEL	DESCRIPTION	New in September	Total
Level 1
1a	Systemic reviews of randomized controlled trials		0
1b	Randomized controlled trials		3
1c	Randomized controlled trials for robotic technique studies		1
Level 2
2a	Systematic reviews of only comparison studies and Independent database population studies	5	16
2b	Prospective non-randomized studies and RCTs with N<20	1	16
Level 2
2a	Systematic reviews of mixed studies (comparison and single arm)		2
2b	Retrospective non-randomized studies and prospective comparison studies with N<20	11	171
Level 4
4a	Literature reviews	1	8
4b	Single arm studies and retrospective comparison studies with N<20	16	183
Level 5	Case reports, Animal and Cadaver studies, Expert Opinion and Editorials	25	491
TOTAL		59	891

Clinical Research for da Vinci® Practitioners

Clinical practitioners of da Vinci Surgery 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.

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PN 105334 Rev B 2/14

All surgery presents risk, including da Vinci® Surgery and other minimally invasive procedures. Serious complications may occur in any surgery, up to and including death. Examples of serious or life-threatening complications which may require hospitalization include injury to tissues or organs, bleeding, infection or 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. Risks of surgery also include potential for equipment failure and human error. Risks specific to minimally invasive surgery may include: A long operation and time under anesthesia, conversion to another technique or the need for additional or larger incisions. If your surgeon needs to convert the procedure, it could mean a long operative time with additional time under anesthesia and increased complications. Temporary pain or discomfort may result from pneumoperitoneum, the presence of air or gas in the abdominal cavity used by surgeons in minimally invasive surgery. Research suggests that there could be an increased risk of incision-site hernia with single-incision surgery. Results, including cosmetic results, may vary. Patients who bleed easily, who have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci® Surgery. For more complete information on surgical risks, safety, and indications for use, please refer to http://www.davincisurgery.com/safety/. Patients should talk to their doctors about their surgical experience and to decide if da Vinci Surgery is right for them. Other options may be available. Intuitive Surgical reviews clinical literature from the highest level of evidence available to provide benefit and risk information about use of the da Vinci Surgical System in specific representative procedures. We encourage patients and physicians to review all available information on surgical options and treatment in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.