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Oncological Outcomes of Denonvilliers’ Fascia Preservation versus Resection During Laparoscopic Total Mesorectal Excision for Male Rectal Cancer Patients: Results from the Chinese PUF-01 Randomized Controlled Trial
26 Pages Posted: 20 Jan 2023
More...Abstract
Background: Traditional total mesorectal excision (TME) for rectal cancer requires partly resection of Denonvilliers’ fascia (DVF), which may lead to injury of pelvic autonomic nerve and postoperative urogenital dysfunction. The previous PUF-01 study has proved that TME with entire preservation of DVF has protective effect on postoperative urogenital function. However, whether preservation of DVF has a comparable oncological outcome with resection of DVF is still unclear.
Methods: The PUF-01 study was an open-label, multicenter, randomized clinical superiority trial conducted at 11 centers in China. From August 26, 2015 through May 6, 2020, a total of 262 eligible male patients with T1-4 (T1-2 for anterior rectal wall) N0-2M0 rectal cancer were enrolled and randomly assigned to Laparoscopic TME with DVF preservation (L-DVF-P, Exp-group) or resection procedures (L-DVF-R, Con-group). The postoperative urogenital function (primary endpoint) was assessed and reported in previously published paper. The secondary endpoints containing 3-year overall survival (OS), disease-free survival (DFS) and recurrence rate, were calculated. The final follow-up was on October 24th, 2022. This study is registered with ClinicalTrials.gov, number NCT02435758.
Findings: Among 262 patients, 242 cases finally completed the study, containing 122 cases of L-DVF-P and 120 cases of L-DVF-R. There were no statistical differences in demographic and clinical characteristics, perioperative surgical and pathological data between the two groups. The 3-year OS was 95.8% in the Exp-group and 91.3% in the Con-group (Log-rank P=0.16; hazard ratio [HR], 0.49; 95% CI, 0.18-1.34). The 3-year DFS was 88.3% in the Exp-group and 87.2% in the Con-group (Log-rank P=0.77; HR, 0.90; 95% CI, 0.43-1.86). At the last follow-up, 37 patients (15.3%) were diagnosed as recurrence. The recurrence rate was of no significant difference between the two groups (n=19, 15.6% in Exp-group and n=18, 15.0% in Con-group, respectively, P=0.901).
Interpretation: For male rectal cancer patients with specific staging and location, L-DVF-P revealed a similar 3-year OS and DFS compared with traditional L-DVF-R.
Funding: This study was supported by grants from the Sun Yat-Sen University Clinical Medicine Research 5010 Program (No. 2015016), National Natural Science Foundation of China (No. 81971378, No. 81901471) and Natural Science Foundation of Guangdong Province (No. 2021A1515010577, No. 2022A1515012653).
Declaration of Interests: The authors have no actual or potential conflicts of interest to declare.
Ethics Approval: The protocol was approved by the Ethics Committee of the Third Affiliated Hospital, Sun Yat-Sen University. Patients were enrolled from August 26, 2015, through May 6, 2020. All candidates provided written informed consent.
Trial Registration: This study is registered with ClinicalTrials.gov, number NCT02435758.
Keywords: Denonvilliers' fascia, total mesorectal excision, rectal cancer, overall survival, disease-free survival
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