• Masaaki Ito, Yuichiro Tsukada, Jun Watanabe, Yosuke Fukunaga, Yasumitsu Hirano, Kazuhiro Sakamoto, Hiroki Hamamoto, Masanori Yoshimitsu, Hisanaga Horie, Nobuhisa Matsuhashi, Yoshiaki Kuriu, Shuntaro Nagai, Madoka Hamada, Shinichi Yoshioka, Shinobu Ohnuma, Tamuro Hayama, Koki Otsuka, Yusuke Inoue, Kazuki Ueda, Yuji Toiyama, Satoshi Maruyama, Shigeki Yamaguchi, Keitaro Tanaka, Motoko Suzuki, Takeshi Naitoh, Koji Ando, Masahiko Watanabe, and Ultimate Trial Group.
• Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan.
• Ann. Surg. 2024 Apr 1.

ObjectiveTo clarify the long-term oncological outcomes and postoperative anal, urinary, and sexual functions after laparoscopic surgery for clinical stage I very low rectal carcinoma located near the anal canal.Summary Background DataLaparoscopic surgery is widely applied for rectal cancer; however, concerns remain, with some studies showing poorer outcomes compared to open surgery.MethodsThis single-arm, phase II trial included patients registered preoperatively from 47 institutions in Japan. The planned sample size was 300. The primary endpoint was the 3-year local recurrence rate. Anal, urinary, and sexual functions were evaluated using a prospective questionnaire.ResultsThree-hundred patients were registered between January 2014 and March 2017. Anus-preserving surgery was performed in 278 (93%), including 172 who underwent intersphincteric resection (58%) and 106 (36%) who underwent low anterior resection. The 3-year cumulative local recurrence rate was 6.3%. At 3 years postoperatively, 87% of patients used their own anus, and the median incontinence score improved from 12 at 3 months to 8 at 3 years. Only 5% of patients had severe incontinence (incontinence score of 16 points). Postoperative urinary function evaluation showed that International Prostate Symptom Score and Overactive Bladder Symptom Score decreased 1 week after surgery, but recovered to preoperative level 1 month after surgery. International Consultation on Incontinence Questionnaire-Sort Form remained almost stable after surgery. Sexual function evaluation using the International Index of Erectile Function-5 and International Index of Erectile Function-15 revealed that the patients had deteriorated 3 months after surgery but had recovered only slightly by 6 months.ConclusionsLaparoscopic surgery achieves feasible long-term oncological outcomes and a high rate of anus preservation with moderate anal function, and an acceptable incontinence score. While urinary function recovered rapidly, sexual function showed poor recovery.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.

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