Preservation versus resection of Denonvilliers' fascia in total mesorectal excision for male rectal cancer: follow-up analysis of the randomized PUF-01 trial

Abstract

Traditional total mesorectal excision (TME) for rectal cancer requires partial resection of Denonvilliers' fascia (DVF), which leads to injury of pelvic autonomic nerve and postoperative urogenital dysfunction. It is still unclear whether entire preservation of DVF has better urogenital function and comparable oncological outcomes. We conducted a randomized clinical trial to investigate the superiority of DVF preservation over resection (NCT02435758). A total of 262 eligible male patients were randomized to Laparoscopic TME with DVF preservation (L-DVF-P group) or resection procedures (L-DVF-R group), 242 of which completed the study, including 122 cases of L-DVF-P and 120 cases of L-DVF-R. The initial analysis of the primary outcomes of urogenital function has previously been reported. Here, the updated analysis and secondary outcomes including 3-year survival (OS), 3-year disease-free survival (DFS), and recurrence rate between the two groups are reported for the modified intention-to-treat analysis, revealing no significant difference. In conclusion, L-DVF-P reveals better postoperative urogenital function and comparable oncological outcomes for male rectal cancer patients.

Fig. 1. CONSORT diagram, including enrollment and outcomes.

L-DVF-P, laparoscopic total mesorectal excision with Denonvilliers’ fascia preservation; L-DVF-R, laparoscopic total mesorectal excision with Denonvilliers’ fascia resection.

Fig. 2. Overall Survival (OS) for laparoscopic total mesorectal excision (TME) with Denonvilliers’ fascia preservation (Exp-group) vs laparoscopic TME with Denonvilliers’ fascia resection (Con-group) at 3 years after surgery.

Kaplan–Meier method was used to estimate survival probabilities over time and the log-rank test was applied to compare survival curves between two groups. a Patients with all stages of cancer. b Patients with TNM stage I cancer. c Patients with TNM stage II cancer. d Patients with TNM stage III cancer.

Fig. 3. Disease Free Survival (DFS) for laparoscopic TME with Denonvilliers’ fascia preservation (Exp-group) vs laparoscopic TME with Denonvilliers’ fascia resection (Con-group) at 3 years after surgery.

Kaplan–Meier method was used to estimate survival probabilities over time and the log-rank test was applied to compare survival curves between two groups. a Patients with all stages of cancer. b Patients with TNM stage I cancer. c Patients with TNM stage II cancer. d Patients with TNM stage III cancer.