Effectiveness of laparoscopic cholecystectomy explored.

Effective of Laparoscopic Cholecystectomy Explored

More than 25 million people in the United States suffer from cholelithiasis--10 million diagnosed and 15 million asymptomatic. There are more than one million newly diagnosed cases, and 543,364 cholecystectomies were performed in the United States in 1989. Treatment modalities for gallstones include medical management with oral dissolution agents, extracorporeal shock wave lithotripsy, percutaneous dissolution of the stones, and surgical removal of the gallbladder.

Cholecystectomy has long been the gold standard for cholelithiasis, providing the definitive cure, removal of the gallbladder. It is the most common elective intradominal procedure performed in the United States. It has extremely low morbidity and mortality. Overall operative mortality is less than 0.5 percent, and most of this is attributable to underlying cardiovascular disease. The major disadvantages of the procedure are that it is relatively painful and the average postcholecystectomy hospital stay is 5-7 days, followed by a 3-8 week absence from work. It is performed in almost every surgical suite in the country, from teaching centers to community hospitals, with minimal variation in morbidity and mortality.

Since October 1989, cholecystectomies have been performed in the United States using laparoscopic techniques. The same laparoscopic principles that have been used for gynecologic surgery since the 1960s have now been applied ro remove gallbladders. Clinical advantages of the laparoscopic technique appear to be sixfold: a decrease in postoperative pain because of the very small incision, decreased rupture of parietal incision, decreased wound dehiscence, decreased postoperative adhesions, improved cosemesis, and a simplified postoperative course and thus rapid patient recovery.

To date, there have been an estimated 8,000 laparoscopic cholecystectomies performed throughout the country. Experienced surgeons perform this procedure, including an intraoperative cholangiogram, in about 96 minutes. The vast majority of patients have been discharged from the hospital the same day or from a 23-hour "short-stay" floor.

The retrospective component of the study that the AMA is conducting involves evaluating the hospital costs, length of stay, postoperative course, complications, and disability days for 250 laparoscopic cholecystectomy patients compared to 250 conventional open cholecystectomy controls (age and comorbidity matched). Measurements of how soon the patient returns to work will be used to estimate the economic impact the procedure will have on the national GNP. The prospective component of the study involves setting up a registry of cases that will serve as a lrototype for future AMA technology assessments.

Our cost-effectiveness analysis will measure the economic impact on length of hospital stay. Conventional cholecystectomies require a 5- to 7-day stay on average. Reduction of stay to a day or less could save an estimated three million inpatient days and $4 billion in national health care expenditures. The impact of decreased hospital charges and postoperative care, decreased nursing charges, and decreased postoperative pain management will be hard data recorded in both laparoscopic cholecystectomy and conventional "open" cholecystectomy. The economic effects of decreased disability days, decreased insurance costs and premiums, and increased national productivity resulting from the patient returning to work sooner will all be estimated. Similarly, the impact of the procedure on the GNP will be an estimate generated from the study data.

Diffusion of the Technology

Laparoscopic cholecystectomy is diffusing at a meteoric rate that is clearly patient-driven. In the centers that were early to adopt the technique, patients now opt for the laparoscopic "closed" cholecystectomy over the conventional "open" procedure. In fact, centers that now offer the laparoscopic procedure are garnering patients not only from other local hospitals but also from other regions of the country. It may be that this first group of patients is highly motivated and self-selected, but they clearly value the patient benefits offered by the laparoscopic procedure. While the 8,000 laparoscopic cholecystectomies done to date represent only 1.3 percent of all cholecystectomies performed each year, it is prudent to emphasize caution until the U.S. experience increases.

Credentialing

One reason for the rapid diffusion of this technology may be the fact that no formal regulatory approval is required. The instruments used have previously received FDA approval for gynecologic surgery. The principal regulatory function governing who performs the procedure is decentralized, residing in each hospital's credentialing committees. The credentialing committees customarily require that the surgeon have experience in biliary surgery, have attended a certified three-day course, and have performed 5-10 procedures under the guidance of an experienced preceptor. The decision to grant privileges to do the laparoscopic procedure requires a determination of the surgical skills and judgment of each surgeon.

Reimbursement

Laparoscopic cholecystectomies are being performed by busy community-based general surgeons and a few academic centers. The fact that this technology didn't emanate from prestigious academic centers is one reason for the dearth of published data on the procedure. Another is the speed of the diffusion.

The current reimbursement landscape is uneven and sometimes inconsistent. The following is not a scientific or representative list but merely represents examples of the policies of some carriers on laparoscopic cholecystectomies at the time of this writing. The national Blue Cross/Blue Shield Association has not yet completed a formal evaluation of the technology, and local Plans are making their own decisions. Medicare has provided coverage and decides on a case-by-case basis. Prudential, Aetna, the Hartford, EQUICOR, CIGNA, Metropolitan, and Mutual of Omaha currently favor the procedure.

Future Considerations

Consideration of the important patient benefits of laparoscopic surgery and the enthusiastic early acceptance of this technique for cholecystectomy by both patients and surgeons forces us to speculate on the future for laparoscopic techniques. Currently, laparoscopic appendectomies are being performed for acute appendicitis. Research is under way on laparoscopic inguinal herniorrhaphy, parietal cell vagotomy, pyloroplasty, and esophageal reflux operations. In addition, the laparoscopic technique is currently being used in lieu of lapartomy for second-look operations for patients who are status/post colon resection for colon cancer, as the technique appears to be particularly well-suited for patients who may have abdominal adhesions secondary to previous surgery.

Don Conway, MD, MBA, is Director, Department of Technology Management, American }e ical Association, Chicago, Ill. He also directs the AMA Trends program, which advises physicians and organizations on technology acquisition and coordinates major national multicenter studies of the safety and effectiveness of new technologies.