By Christina Frangou
Vancouver, British Columbia—The majority of Americans who undergo colon surgery this year will not be offered a laparoscopic surgical approach, according to specialists at the 2011 annual meeting of the American Society of Colon and Rectal Surgeons (ASCRS).
Three recent studies reported low rates of laparoscopic colon cancer surgery, with estimates ranging from 30% to as low as 10%. At a meeting organized by Ethicon Endo-Surgery during the ASCRS, experts in laparoscopic surgery argued that too few patients in the United States are offered laparoscopic colorectal procedures.
“Despite evidence supporting laparoscopic surgery, less than half of colorectal procedures are performed using minimally invasive techniques,” said Michael J. Stamos, MD, professor and chair of surgery at the University of California, Irvine. “It is essential that surgeons are trained in techniques and patients and health systems are aware of the benefits of laparoscopic surgery.”
In 2004, the landmark randomized COST (Clinical Outcomes of Surgical Therapy) trial demonstrated that the laparoscopic approach offers equivalent oncologic outcomes for colon cancer but better short-term results than traditional open surgery, with decreased hospital length of stay and less postoperative pain (N Engl J Med 2004;350:2050-2059). Although there are advantages to open surgery, namely a shorter operating time and lower costs, the advantages for the patient appear to be on the side of laparoscopy, investigators concluded.
Other multicenter studies since have shown similar results (e.g., Lancet Oncol 2005;6:477-484; Lancet Oncol 2009;10:44-52). A 2005 Cochrane Review, which included 25 randomized controlled trials, found that patients who undergo laparoscopic colorectal surgery have less intraoperative blood loss than those who have conventional surgery. Patients have less intense postoperative pain and shorter postoperative ileus after laparoscopic colon resection. Their hospital lengths of stay are shorter, they return to work earlier and, until postoperative day 30, their quality of life is better (Cochrane Database Syst Rev;:CD003145).
And at this year’s ASCRS meeting, general surgery residents from Oregon Health & Science University, Portland, reported results from an analysis of National Surgicl Quality Improvement Project (NSQIP) data, which looked at predictors of 30-day mortality after elective colectomy (AB GSF–6). The study included 14,170 patients who underwent open colectomy and 10,310 who had laparoscopic colectomy between 2005 and 2008. Using a multivariate logistic regression model, they found laparoscopy dramatically decreased 30-day postoperative morbidity for colectomy. Many of these complications were linked to increased mortality rates, although laparoscopy itself did not affect mortality rates in any way. The investigators concluded that “while laparoscopy had no independent effect on 30-day mortality, it decreased complications that would otherwise increase 30-day mortality.”
Slow Rise of Laparoscopy
Although open procedures are much more common, laparoscopic procedures have spread slowly over the past eight years. In a study published this summer, national data indicate that almost 90% of cases are still performed open, but that the percentage of laparoscopic procedures has doubled or tripled in some cases (Ann Surg 2011 Jun 16. [Epub ahead of print]). The investigators analyzed data collected in the Nationwide Inpatient Sample from 2001 to 2003 and from 2005 to 2007. Comparisons showed that laparoscopic colectomy for benign disease increased from 6.2% before the trial to 11.8% in the later years, and laparoscopic rates for colon cancer increased from 2.3% to 8.9%.
Celia N. Robinson, MD, general surgery research fellow at Baylor College of Medicine in Houston, points out that the use of minimally invasive surgery increased about 5% over eight years, a rate much lower than uptake of other laparoscopic procedures. In comparison, the proportion of cholecystectomies performed laparoscopically increased from 2.5% to 73.7% over the five-year period from 1988 to 1992 and the proportion of Nissen fundoplications performed laparoscopically increased from 1.2% to 49% between 1991 and 1995 (Ann Surg Onc 2011;18:1412-1418). Although there are nearly 1 million cholecystectomies performed in the United States annually, there are fewer than 100,000 colon resections performed during the same time frame, Dr. Robinson said.
Conor Delaney, MB, PhD, professor of surgery at Case Western Reserve University, Cleveland, concluded that all patients who are eligible for laparoscopic surgery should “be informed that laparoscopic surgery is an option with important and measurable benefits, like decreased recovery time. We’re even seeing some evidence now that patients start chemotherapy a lot earlier with laparoscopic surgery. These are true advantages that patients should be aware of.”
Reasons for the Lag
So why do so few patients undergo laparoscopic surgery? Experts attribute the low adoption rate to three things: a lack of knowledge about the benefits of laparoscopic surgery for the colon, the difficulty of training surgeons who are already in practice and the complexity of the procedure itself.
Of the three, lack of knowledge may be the biggest barrier, said Dr. Delaney. Many surgeons, patients and referring doctors are unaware that laparoscopic surgery can translate to marked improvements in health and quality of life in the months following surgery, he said.
Dr. Stamos agreed: “I think there’s a significant number of patients, gastroenterologists, even surgeons who don’t know that the laparoscopic approach does have better short-term outcomes for patients.”
Many primary care doctors and gastroenterologists refer patients based on their longstanding relationships with a surgeon and his or her reputation and outcomes, rather than a surgeon’s adoption of new technologies. They do not closely follow the surgical literature on the open-versus-laparoscopic debate and see little cause to change referral patterns.
Baylor University gastroenterologist and president of the American Gastroenterological Association, C. Richard Boland, MD, said the laparoscopic-versus-open debate is “not a particularly hot topic” among gastroenterologists. “It’s just about never discussed among medical gastroenterologists.”
He refers patients to both types of surgeons, those who operate laparoscopically and those who prefer open procedures. Noting that he is not a specialist in the area, he said he is unaware of anything in the literature that shows the superiority of one approach.
That’s an argument made by many surgeons, too, who point out that published studies show that the long-term outcomes are equivalent between the two procedures even if there are differences in the first few months. A Cochrane Review, published in 2008, suggests that in the long term, there is no measurable advantage with laparoscopic compared with the open approach (Cochrane Database Syst Rev 2008;:CD00343). After analyzing 33 randomized controlled trials, the researchers concluded that “laparoscopic resection of carcinoma of the colon is associated with long-term outcomes no different from that of open colectomy.”
The authors noted that more studies are needed to determine whether the incidence of incisional hernias and adhesions is affected by method of approach.
Even follow-up studies after the original COST trial suggest any differences long-term are minimal (Ann Surg Oncol 2011 Mar 31. [Epub ahead of print]). An analysis of 499 patients enrolled in trial showed a slight improvement in quality of life for patients randomized to laparoscopic surgery 18 months after their operation. “However, the magnitude of the benefits was small,” the authors concluded.
With long-term outcomes being similar between the two procedures, some surgeons question how high the laparoscopic utilization rates should be.
“I would ask why does the adoption rate need to be higher? Perhaps there is a point at which that really should be the plateau? How many operations can be performed by people who have the volume to be good at [laparoscopic surgery]?” asked George Chang, MD, colorectal surgeon at the University of Texas MD Anderson Cancer Center, Houston, in a question-and-answer period during an ASCRS session on minimally invasive techniques.
Advocates say, however, that as long as evidence favors laparoscopic surgery, even just in terms of short-term outcomes, every effort should be made to make the procedure available to eligible patients.
“I would argue that if you believe laparoscopic surgery is a benefit to patients, then that figure should be as high as it can be for wherever you are locally,” said Mark Whiteford, MD, a colorectal surgeon at The Oregon Clinic, Portland. “I really believe that I still see a difference in my patients [receiving laparoscopic surgery] one month later. Before knowing what procedure the patient had, I ask my residents in clinic to predict, based on their initial impression of the patient's comfort and mobility, if the patient had a lap or open operation, and they are nearly always correct and surprised at the clear difference,” he said.
The growth of laparoscopy has not been uniform across the population. Adoption has been spotty and sporadic, with swift uptake in some regions, notably urban centers, and minimal penetration in rural regions. And as often occurs with newer technologies, the patients most likely to undergo laparoscopy are male and white, have health insurance, live in areas with the highest income levels and undergo treatment at urban hospitals.
Adoption rates also are slower due to the high degree of complexity and the significant costs to health systems. The laparoscopic procedure is more expensive, with longer operating times, a high learning curve and high conversion rate of 25% to 36% early in the learning curve. The recent Annals of Surgery study reported that the laparoscopic operation is associated with an increase in charges per hospitalization for patients undergoing laparoscopic surgery, amounting to a rise of $2,900 (health care–inflation adjusted) for benign disease and $5,700 for colon cancer. The authors noted other data indicate that the cost increase is most significant early in the learning curve.
Moreover, the operations are difficult, involving multiple organs and multiple quadrants. Many of the patients are extremely sick, with multiple comorbidities and a high risk for severe adhesions. Some hospitals lack dedicated suites. In some places, institutional culture that’s against deviating from the norm can make surgeons less likely to attempt laparoscopy in new procedures.
But much of the slow adoption has to do with surgeons themselves, said Dr. Whiteford. “I think surgeon factors are one of the biggest things. If you are a surgeon who has read the data and you interpret it as equivocal, you’re not going to go for laparoscopic surgery. It is a big undertaking. But if you are someone who reads the literature like I do, and think it’s beneficial, then you will go for it.”
Studies show that surgeon demographics matter when it comes to their decision to use laparoscopic surgery. Younger surgeons starting out in practice, particularly those with additional training in minimally invasive surgery or in colorectal surgery, are more likely to perform laparoscopic colon surgery (Can J Surg 2009;52:455-462). Older general surgeons who have been in practice for more years, and who perform the bulk of colorectal surgery procedures in the United States, are less likely to switch to laparoscopy.
It’s an expensive undertaking for a surgeon to commit to additional training when they are already practicing. They often have to take time off to train. And once they are finished, it can take a long time to recover financially. The learning curve is estimated at 30 to 50 cases and higher for more difficult cases. Throughout the learning curve, the procedures take longer and many surgeons lack adequate block time in their operating room (OR) to spend time learning laparoscopy.
In a 2009 survey of Canadian surgeons, respondents said that the lack of adequate OR time and formal training were the main reasons they did not offer laparoscopic colon resections (Can J Surg 2009;52:455-462). Of the 462 surgeons who responded (representing a 55% response rate), about 54% said they perform laparoscopic colorectal surgery. Two out of every three surgeons surveyed said that site visits from a minimally invasive surgeon would be the most effective training method for acquiring advanced laparoscopic skills.
In England, after studies showed that increased laparoscopic procedures led to shorter hospital stays and could help ease waitlists for beds, the health department launched a program to raise laparoscopic adoption rates. The program is centered on the type of site visits that Canadian surgeons said would help with training.
Beginning in 2007, the National Health Service (NHS) in England funded a program to offer training to practicing surgeons who performed a high enough volume of colon surgery to warrant the cost of training. The decision came after a cost–benefit analysis suggested that increasing the percentage of laparoscopic colorectal procedures would result in shorter hospital stays, thereby opening up beds for other patients, and at the same time improving the patient experience. They estimated a reduction of more than 6,400 bed-days based on 25% use of laparoscopic colorectal cancer surgery.
The NHS set up a network of training centers and identified a group of experienced trainers who could teach other surgeons. The result? The national laparoscopic colectomy rate has reached 30%, up from less than 5% in 2004.
However, their experience might not be applicable in the United States. “It may be difficult to translate the same rate of adoption in the United States, which is mostly rural carrying a much lower population density than the United Kingdom, and currently operates a very different health care delivery system, ” wrote American surgeons in the Annals of Surgery this summer (Jun 16. [Epub ahead of print]).
Surgeons at the ASCRS called for new efforts to improve training and education of surgeons and referring doctors. “We need to look at new ways of reaching surgeons and providing more and better training opportunities. That’s essential if we’re going to see adoption rates increase,” said Brad Champagne, MD, assistant professor at Case Western Reserve University School of Medicine, Cleveland.
Currently, the ASCRS and the Society of American Gastrointestinal and Endoscopic Surgeons, as well as leaders in the industry, sponsor a number of physician-led courses throughout the year. For full details on training, see the accompanying piece, “Training Opportunities in Lap Colectomy on the Rise,” above.