Target Audience and Goals:
Gynecologic oncologists, obstetricians/gynecologists, primary care physicians, surgeons, internists
The goals of the study were to determine whether minimally invasive robotic surgery (MIRS), approved for treating gynecologic conditions in Denmark in 2005, reduced rates of serious complications in women with early-stage endometrial cancer, and whether the introduction of MIRS increased the overall use of minimally invasive surgery (MIS) in this setting.
Questions Addressed:
- Did the national introduction of MIRS in Denmark reduce the primary outcome of severe complications, defined as 30-day mortality and any intraoperative and post-operative complications in patients with early-stage endometrial cancer?
- How did complication rates compare among those treated with minimally invasive laparoscopic surgery (MILS), MIRS, and laparotomy?
- What was the rate of increase of MIRS in Denmark after its introduction?
Study Synopsis and Perspective:
MILS for endometrial cancer has been associated with reduced complication rates compared with total abdominal hysterectomy in a number of randomized trials, but the uptake of MILS was not rapid in Denmark before the introduction of robotic assistance.
After the introduction on a nationwide basis in Denmark in 2005, MIRS was associated with the performance of a greater proportion of MIS, as well as lower serious complication rates than laparotomy in patients with International Federation of Gynecology and Obstetrics stage I or II endometrial cancer, according to researchers led by Siv Lykke Jørgensen, MD, of Odense University Hospital in Denmark.
In Denmark, the treatment of early-stage endometrial cancer was centralized from 28 centers to 6 national cancer centers starting in 2005, each of which implemented MIRS from 2008 to 2013. The authors believe that this centralization produced a high flow of patients and “optimal conditions for improving surgical expertise.”
As the use of MIRS rolled out across the country, the rate of total abdominal hysterectomy dropped from 85.9% to 27.8%, while MIS increased from 14.1% to 72.2% (MILS 22.2%, MIRS 50.0%), the authors reported in JAMA Surgery.
The research team defined serious complications as 30-day mortality, and severe intraoperative and postoperative complications. Severe intraoperative complications included unintended vascular, urinary tract, bowel, or nerve damage; severe postoperative complications encompassed the 90 days following surgery and included acute renal failure, paralytic ileus, deep venous thrombosis, pulmonary embolism, acute myocardial infarction, sepsis, fistula, postoperative deep or intra-abdominal hematoma, surgical evacuation of cavities, and the need for gynecologic reoperation.
The nationwide registry study included 5,654 women with early-stage disease who underwent surgery from January 1, 2005 to June 30, 2015. These women were divided into two groups:
- Group 1 included 3,091 women who underwent surgery before the introduction of MIRS in their regions
- Group 2 included 2,563 women who underwent surgery after the introduction of MIRS
In group 1, 7.3% had severe complications compared with 6.2% in group 2. In multivariate logistic regression analyses, women in group 1 were found to have a significantly greater risk of developing complications compared with women in group 2 (OR 1.39, 95% CI 1.11-1.74).
In group 2 — those in the post-MIRS period — severe complications occurred in 81 of 712 women who underwent total abdominal hysterectomy (11.4%), 29 of 569 women who underwent MILS (5.1%), and 59 of 1,282 women who underwent MIRS (4.6%). In this group, total abdominal hysterectomy was associated with increased odds of complications compared with either type of MIS:
- MILS (OR 2.58, 95% CI 1.80-3.70)
- MIRS (OR 3.87, 95% CI 2.52-5.93)
No significant difference was seen in complication rates between MILS and MIRS (OR 1.50, 95% CI 0.99-2.27).
The researchers found that the odds of severe complications were associated with lymphadenectomy in group 2, as well as American Society of Anesthesiologists (ASA) score, body mass index, socioeconomic status, and surgical year, but not with age, smoking status, tumor risk group, socioeconomic group, and intra-abdominal adhesions.
Strengths of the study included prospectively entered national data over a 10-year period with the gradual introduction of MIRS. By dividing the subjects into cohorts according to the availability of MIRS, researchers noted that they avoided a comparison across surgical modalities that were not available during the time frame. The study also included 97% of women who had surgery for early-stage endometrial cancer in Denmark, minimizing selection bias.
Limitations of the study included the risk of information bias, which is inherent in registry-based studies. As there may have been an underreporting of minor complications in the registry, the authors included only major complications. The authors were unable to adjust for surgeon-specific learning curve, as information on MILS and MIRS experience of surgeons was not available, though they noted that the MIRS learning curve is reported to be less steep than that of conventional laparoscopy.
Source References:
JAMA Surgery, 2019; DOI: 10.1001/jamasurg.2018.5840
Editorial: JAMA Surgery, 2019; DOI 10.1001/jamasurg.2018.5841
Study Highlights: Explanation of Findings
MIRS was approved for treatment of gynecologic conditions in 2005 in Denmark and rolled out across the nation starting in 2008. Jørgensen and colleagues noted that their data suggest that the implementation of MIRS increased the use of MIS overall and reduced the risk of complications compared to open surgery.
This may be the first analysis of how a nationwide uptake of MIRS affected the risk of surgical complications in an unselected national cohort of women with early-stage endometrial cancer, the authors noted. “The reduction in the number of severe complications was observed despite a higher proportion of women with an older age, a high ASA score, high-risk histopathologic characteristics, and intra-abdominal adhesions being offered MIS and a higher proportion of women undergoing staging lymphadenectomy,” they wrote.
Randomized trials comparing total abdominal hysterectomy vs MIRS have also shown a reduced risk of complications post-MIS, but not all studies have confirmed this, according to Jørgensen’s group, with one U.S. study of Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data showing a rate of 23.7% with MIRS vs 19.5% with MILS. “However, we believe that the increased risk of complications after MIRS compared with MILS is a result of selection bias related to the allocation of women with a higher risk of complications to undergo MIRS rather than to the higher risk of complications after MIRS.”
In a commentary that accompanied the study, Jason D. Wright, MD, of Columbia University in New York City, and colleagues, wrote that the study “demonstrates that minimally invasive hysterectomy is associated with fewer complications than laparotomy and that increasing use of MIS improves surgical outcomes.”
However, the commentary stated, the question remains whether a robotically assisted surgical program is required to increase the use of MIS. With that question in mind, they noted that the study comes with several caveats, including the fact that there was no true control group, and that the results could have been confounded by the fact that endometrial cancer care was centralized into six regional cancer centers in Denmark at the time robotically assisted surgery was being introduced.
“Regardless, Jørgensen and colleagues have demonstrated that increasing the rate of minimally invasive hysterectomy can improve outcomes for women undergoing hysterectomy for early-stage endometrial cancer,” Wright’s group concluded. “Going forward, the use of MIS for early-stage endometrial cancer should be an important quality metric. Programs to promote access to MIS, whether laparoscopic or robotically assisted, should be a priority for women with endometrial cancer.”
Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College and Heidi Wynn Maloni, PhD, ANP-BC, CNRN, MSCN, Nurse Planner
Primary Source
JAMA Surgery
Secondary Source
JAMA Surgery
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