Concerns that resulted in moratorium on laparoscopic procedure resolved
ROCHESTER, Minn. -- When performed by experienced surgeons, minimally invasive laparoscopic surgery is a safe and effective alternative to standard open surgery for most patients with cancer that is confined to the colon.
That is the main finding of a seven-year international study, which will be published in the May 13 issue of the New England Journal of Medicine. The study involves 872 patients with colon cancer and is the most extensive comparison to date of the two surgical techniques. It addresses concerns raised in the early 1990s about higher rates of colon cancer recurrence after laparoscopic surgery. Those concerns resulted in policies recommending that laparoscopic colon surgery not be performed until clinical studies showed it was effective in cancer patients.
Heidi Nelson, M.D., a colorectal surgeon at Mayo Clinic, led the study team of 66 colorectal surgeons at 48 medical centers in the United States and Canada. The study team compared rates of complications, cancer recurrence, length of time patients were cancer-free and the overall survival in both sets of patients.
All patients in the study had been diagnosed with potentially curable cancer of the colon. Each patient was randomly assigned to undergo either the minimally invasive laparoscopic procedure or the standard surgery and was afterwards followed for several years to check for cancer recurrence.
"Our study shows that while laparoscopic surgery is safe and effective for treatment of colon cancer, it must be performed selectively," says Dr. Nelson. "It should not be used for patients whose cancer requires extensive surgery to other organs besides the colon, and it should be done by surgeons who are experienced in performing laparoscopic colon surgery."
This year in the United States about 100,000 people will be diagnosed with colon cancer. More than 90 percent of them will be told they need surgery to remove all or part of the colon or large intestine to get rid of the cancer.
Minimally invasive laparoscopic surgery typically involves the creation of three, half-inch incisions through which a small video camera and surgical instruments are inserted. A two-inch incision is used to bring the colon out of the abdomen, cut away the portion containing cancer, then reconnect the two healthy parts and put the colon back inside the abdomen. With standard surgery, an incision of six to eight inches or longer is required for opening the abdomen to perform the operation.
The National Cancer Institute (NCI) funded this comparison study as a top priority clinical research project. The study was coordinated by the North Central Cancer Treatment Group (NCCTG) in conjunction with other National Cancer Institute Cooperative Groups.
Dr. Nelson listed these findings of the study and benefits to the patient:
- Almost exact rate of recurrence in both sets of patients. The cancer returned in 160 of the 872 patients; 76 had undergone laparoscopic surgery and 84 had the standard operation.
- The return of the cancer in the location of the surgical wound was less than 1 percent in both sets of patients, occurring in two patients who had laparoscopic surgery and one patient who had standard surgery.
- The survival rate was almost identical -- 86 percent of patients who had undergone laparoscopic surgery were alive three years after surgery and 85 percent receiving the standard surgery were alive.
- Similar rates of complications during surgery and within 30 days of surgery in terms of hospital re-admissions, re-operations and deaths.
- Shorter hospitalization for patients who had laparoscopic surgery -- on average, five days in the hospital compared to six days for the standard surgery group.
- Shorter use of intravenous pain-relieving medications after surgery for the laparoscopic group -- three days versus four days. Also, briefer use of oral pain relievers -- one day for laparoscopic group compared to two days for the standard surgery group.
"My impression from many interactions with patients is that the minimally invasive approach is less intimidating to the patient with colon cancer," says Dr. Nelson. "The smaller incision and faster recovery present less of a reminder to the patient about the serious diagnosis."
The use of minimally invasive laparoscopic surgery began in the 1980s for removal of the appendix and gallbladder. The success of those procedures made surgeons think the technique could provide equal benefit for removal of colon cancer. In 1990, surgeons began performing minimally invasive surgery for colon cancer, but stopped in 1994 because of concerns about:
- increased recurrence of cancer at the surgery wound site
- whether laparoscopic surgery provided the same extent of abdominal exploration and information about cancer in the lymph nodes as standard surgery
- whether the laparoscopic technique changed the pattern of cancer cell spread
"These concerns demanded a prospective, randomized comparison of the two procedures to ensure that the laparoscope technique was properly tested before it became widely used for surgical treatment of colon cancer," says Dr. Nelson. "Most surgeons supported this need for critical evaluation and adopted a policy of not performing the laparoscopic procedure outside of a clinical study."
Surgeons participating in this study had to become credentialed and show that they had performed at least 20 laparoscopic colon surgeries. During the study, an audit committee evaluated randomly selected and unedited videotapes submitted by each surgeon to assure proper technique was followed.
Dr. Nelson's advice to patients who are diagnosed with colon cancer and interested in having laparoscopic surgery: Ask how many laparoscopic colon procedures the surgeon performs annually, how familiar he or she is with doing cancer surgeries laparoscopically and where they received their training for laparoscopic colon surgery. If the patient is not comfortable with the answers, she suggests seeking a second opinion or considering the standard open operation.
"I anticipate that as a result of this study, more physicians will become experienced in laparoscopic colon surgery and the procedure will become widely available throughout the United States and Canada," says Dr. Nelson.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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Don't be too timid and squeamish about your actions. All life is an experiment. The more experiments you make the better.
-- Ralph Waldo Emerson