Prospective multicenter study laparoscopic colorectal surgery. Quality control during the development of new surgical methods

During the course of development of laparoscopic surgery, the first success ful procedures involving the colorectum were reported already in 1991 and 1 992. This having demonstrated the principal feasibility of such operations, a study was initiated in German speaking countries in 1995, with the aim o f investigating the efficacy and quality of laparoscopic surgery and involv ing the collection of all the interventions on the colorectum carried out i n the departments participating. In an initial step, and when the first 500 patients had been treated, an in dication spectrum was identified, which differed from the typical spectra o f open colorectal surgery in showing a clear preponderance of benign diseas es. In terms of the intraoperative and post-operative complications develop ing after laparoscopic procedures, however, no differences were to be seen vis-a-vis open surgery. In 167 of the first 500 recorded patients, an intervention for carcinoma wa s done in curative intent. On the basis of a detailed analysis, no trend to wards a restriction of the scope of the procedures was to be seen in the la paroscopically treated patients. Furthermore, the number of dissected lymph nodes, the number of injuries to the tumor and the distal margins of clear ance in the case of rectal resections were comparable with those seen in st udies on open surgery. In the next step of the analysis, now based on large r numbers of patients, an evaluation of the sigmoid diverticulitis subgroup was carried out. A distinct selection of the uncomplicated forms of divert iculitis was found, the rate of intra-operative and post-operative complica tions remained satisfactory and comparable with the figures known for open procedures. The anastomosis was created almost exclusively either transanal with the stapler, or handsewn after exteriorization. In comparison with op en surgery, the rate of anastomotic insufficiencies in the laparoscopic stu dy was no higher than seen in open surgery. The last remaining, an as yet unanswered question is that of the long-term oncological results. Only in a few years time, when a mean follow-up period of more than 5 years has been achieved and the unselected data of all pati ents are available will it be possible to make a statement on the local rec urrence rate as a sign of surgical quality, and on disease-free survival an d 5-year survival rates. Only then we will be able to make a definitive ass essment of the place of laparoscopic surgical in oncological interventions done in curative intent in a comparison with a historical group of open sur gical patients. Until then, all laparoscopic procedures on the colorectum c arried out in curative intent should be limited to prospective studies.