Preclinical and clinical testing of laparoscopic sterilization techniques

Testing laparoscopic instruments for sterility should be conducted according to a three-phased program: Phase I: A basic judgment needs to be made by a panel of clinicians familiar with sterilization as to whether or not a new technique is truely different from standard and documented techniques so as to warrant preclinical animal studies. If this is warranted, these studies should include at least 10 test animals with no pregnancies, compared to 10 control animals where a normal pregnancy rate of 70 to 80 percent is documented. Phase II: After theoretical efficacy of a new technique is documented or accepted, the developer of the technique should test it on at least 50 patients for unexpected clinical difficulties or difficulties in maintenance of equipment. Phase III: At least five prototypes of the sterilization device should then be distributed to experienced clinicians for their evaluation on atleast 100 patients each, with a prospective collection of complications and pregnancy rates in a follow-up of at least 90 percent by the end of a 1-year period. Ideally, the number of such patients should be 1000. A judgment can then be made by an appropriate panel as to the relative hazards and benefits of the technique in comparison with standard rates of safety and efficacy.