Preservation versus resection of Denonvilliers' fascia in total mesorectal excision for male rectal cancer: follow-up analysis of the randomized PUF-01 trial.
Jiafeng FangBo WeiZongheng ZhengJian'an XiaoFanghai HanMeijin HuangQingwen XuXiaozhong WangChuyuan HongGongping WangYongle JuGuoqiang SuHaijun DengJinxin ZhangJun LiXiaofeng YangTufeng ChenYong HuangJianglong HuangJianpei LiuHongbo Weinull nullPublished in: Nature communications (2023)
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.
Keyphrases
- rectal cancer
- locally advanced
- free survival
- phase iii
- end stage renal disease
- double blind
- open label
- phase ii
- patients undergoing
- clinical trial
- newly diagnosed
- prostate cancer
- randomized controlled trial
- robot assisted
- peritoneal dialysis
- type diabetes
- squamous cell carcinoma
- oxidative stress
- minimally invasive
- blood pressure
- study protocol
- adipose tissue
- weight loss
- insulin resistance