What is a meant when a laparoscopic surgical procedure is described as "safe"?

Abstract

Background: The literature on laparoscopic surgery contains many studies concluding that a procedure is "safe." This study aimed to review systematically articles from the past 10 years that judged a laparoscopic technique for colon resection and anastomosis to be "safe."

Methods: The authors searched the Medline database from January 1995 to August 2005 using the search terms "laparoscopic," "colon," and "safe," selecting studies of laparoscopic colon resection or laparoscopic techniques of colonic anastomosis. They calculated exact 95% confidence intervals around estimates of the risk for death reported in the studies to determine the upper limit of the possible risk for death in a study reporting no deaths.

Results: Of 135 studies matching the search criteria, 41 (30%) described operations involving laparoscopic colonic resection or anastomosis. These studies enrolled a mean number of 233 subjects. There were 26 retrospective studies, 12 prospective studies, 2 randomized control trials, and 1 case report. The estimated upper 95% confidence limits for studies reporting mortality ranged from 1.66% to 97.5%. Of the studies that reported mortality and concluded that laparoscopic colon surgery is "safe," 77.8% could not exclude a mortality rate higher than 5%.

Conclusion: Many studies concluding that laparoscopic colon surgery is "safe" could not exclude a high risk of operative mortality. The term "safe" is not a useful descriptor of the relative safety of laparoscopic surgical procedures, and statements about the safety of a surgical procedure should be justified with precise estimates and confidence intervals of the risk for adverse events.