Quality assurance of pelvic autonomic nerve-preserving surgery for advanced lower rectal cancer--preliminary results of a randomized controlled trial.

BACKGROUND: Pelvic autonomic nerve-preserving (PANP) lateral node dissection (LLND) has been introduced in rectal cancer surgery in Japan, but quality assurance of this approach has not been tested by randomized controlled trials.

METHODS: Patients with advanced lower rectal cancer were randomized either to complete PANP + LLND surgery combined with intraoperative radiotherapy (preserved group; n = 28) or to pelvic autonomic nerve resection + LLND surgery (resected group; n = 27). Operation-related parameters were compared statistically.

RESULTS: Patient and tumor characteristics were well comparable. The incidence of anastomotic breakdown, intrapelvic abscess, and small bowel obstruction was not different between the two groups. In the preserved group, no patients had ureteral stenosis, pelvic bone fractures, or peripheral neuropathy due to intraoperative radiotherapy. Sphincter-preserving operation was possible with similar ratio in both groups. Adjuvant chemotherapy was given with similar ratio in both groups. The average operation time was 513 minutes in the preserved group and 409 minutes in the resected group, with a significant difference between the two groups. The average amount of hemorrhage was not different significantly between the preserved group (996 ml) and the resected group (970 ml). Circumferential resection margin status and operative curability were similar between the two groups. The average number of harvested and metastatic nodes in the mesentery and pelvic sidewall was not different significantly between the two groups.

CONCLUSIONS: This study revealed, for the first time, that the surgical quality of PANP + LLND is the same as pelvic autonomic nerve resection + LLND.