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 successful procedures involving the colorectum were reported already in 1991 and 1992. This having demonstrated the principal feasibility of such operations, a study was initiated in German speaking countries in 1995, with the aim of investigating the efficacy and quality of laparoscopic surgery and involving the collection of all the interventions on the colorectum carried out in the departments participating. In an initial step, and when the first 500 patients had been treated, an indication spectrum was identified, which differed from the typical spectra of open colorectal surgery in showing a clear preponderance of benign diseases. In terms of the intraoperative and post-operative complications developing 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 was done in curative intent. On the basis of a detailed analysis, no trend towards a restriction of the scope of the procedures was to be seen in the laparoscopically treated patients. Furthermore, the number of dissected lymph nodes, the number of injuries to the tumor and the distal margins of clearance in the case of rectal resections were comparable with those seen in studies on open surgery. In the next step of the analysis, now based on larger numbers of patients, an evaluation of the sigmoid diverticulitis subgroup was carried out. A distinct selection of the uncomplicated forms of diverticulitis was found, the rate of intra-operative and post-operative complications 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 open surgery, the rate of anastomotic insufficiencies in the laparoscopic study 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 patients are available will it be possible to make a statement on the local recurrence rate as a sign of surgical quality, and on disease-free survival and 5-year survival rates. Only then we will be able to make a definitive assessment of the place of laparoscopic surgical in oncological interventions done in curative intent in a comparison with a historical group of open surgical patients. Until then, all laparoscopic procedures on the colorectum carried out in curative intent should be limited to prospective studies.