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Randomized Controlled Trial
Effect of Denonvilliers' Fascia Preservation Versus Resection During Laparoscopic Total Mesorectal Excision on Postoperative Urogenital Function of Male Rectal Cancer Patients: Initial Results of Chinese PUF-01 Randomized Clinical Trial.
- Bo Wei, Zongheng Zheng, Jiafeng Fang, Jian'an Xiao, Fanghai Han, Meijin Huang, Qingwen Xu, Xiaozhong Wang, Chuyuan Hong, Gongping Wang, Yongle Ju, Guoqiang Su, Haijun Deng, Jinxin Zhang, Jun Li, Tufeng Chen, Yong Huang, Jianglong Huang, Jianpei Liu, Xiaofeng Yang, Hongbo Wei, and Chinese Postoperative Urogenital Function (PUF) Research Collaboration Group.
- Department of Gastrointestinal Surgery, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.
- Ann. Surg. 2021 Dec 1; 274 (6): e473-e480.
ObjectiveTo compare the outcomes of laparoscopic total mesorectal excision (L-TME) with Denonvilliers' fascia (DVF) preservation versus resection on urogenital function of male patients with rectal cancer.BackgroundThe protective effect of DVF during L-TME on pelvic autonomic nerves and postoperative urogenital function remains controversial.MethodsBetween August 26, 2015 and July 18, 2019, 253 male patients with cT1-4 (T1-2 for anterior wall) N0-2M0 rectal cancer from 11 institutions were enrolled, and randomly assigned to L-TME with DVF preservation (Exp-group, n = 123) or resection procedures (Con-group, n = 130). Urinary function was assessed by residual urine volume, maximal flow rate, and International Prostate Symptom Score; sexual function was assessed by 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation grading.ResultsThe Exp-group patients showed a lower urinary dysfunction rate (6.8% vs 25.4%, P = 0.003), higher maximal flow rate (16.25 ± 8.02 vs 12.40 ± 7.05 mL/s, P = 0.007), and lower International Prostate Symptom Score (6.55 ± 5.86 vs 8.57 ± 5.85, P = 0.026) than the Con-group patients at 2 weeks after surgery. The incidence of erectile dysfunction (IIEF-5 ≤ 11) at 12 months after surgery was lower in the Exp-group than in the Con-group (12.5% vs 34.2%, P = 0.023); Exp-group manifested superior IIEF-5 (16.63 ± 6.28 vs 12.26 ± 6.83, P = 0.018). The incidence of ejaculation dysfunction was lower in the Exp-group than in the Con-group at 12 months after surgery (10.0% vs 29.4%, P = 0.034).ConclusionsDVF preservation during L-TME revealed protective effects on postoperative urogenital function, and could be a better choice for male rectal cancer patients with specific staging and location.Trial Registration NumberNCT02435758.Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.
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