Ito Masaaki, Tsukada Yuichiro, Watanabe Jun, Fukunaga Yosuke, Hirano Yasumitsu, Sakamoto Kazuhiro, Hamamoto Hiroki, Yoshimitsu Masanori, Horie Hisanaga, Matsuhashi Nobuhisa, Kuriu Yoshiaki, Nagai Shuntaro, Hamada Madoka, Yoshioka Shinichi, Ohnuma Shinobu, Hayama Tamuro, Otsuka Koki, Inoue Yusuke, Ueda Kazuki, Toiyama Yuji, Maruyama Satoshi, Yamaguchi Shigeki, Tanaka Keitaro, Suzuki Motoko, Naitoh Takeshi, Ando Koji, Watanabe Masahiko
Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan.
Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.
Ann Surg. 2024 Apr 1;281(2):304-11. doi: 10.1097/SLA.0000000000006290.
To 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.
Laparoscopic surgery is widely applied for rectal cancer; however, concerns remain, with some studies showing poorer outcomes compared to open surgery.
This 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.
Three-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.
Laparoscopic 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.
明确腹腔镜手术治疗临床I期、位于肛管附近的极低位直肠癌的长期肿瘤学结局以及术后肛门、泌尿和性功能情况。
腹腔镜手术已广泛应用于直肠癌治疗；然而，仍存在一些担忧，一些研究表明与开放手术相比，其结局较差。
这项单臂II期试验纳入了日本47家机构术前登记的患者。计划样本量为300例。主要终点是3年局部复发率。使用前瞻性问卷对肛门、泌尿和性功能进行评估。
2014年1月至2017年3月期间登记了300例患者。278例（93%）患者接受了保肛手术，其中172例（58%）接受了括约肌间切除术，106例（36%）接受了低位前切除术。3年累积局部复发率为6.3%。术后3年，87%的患者使用自身肛门，失禁评分中位数从术后3个月的12分改善至3年时的8分。只有5%的患者有严重失禁（失禁评分为16分）。术后尿功能评估显示，国际前列腺症状评分和膀胱过度活动症症状评分在术后1周下降，但术后1个月恢复到术前水平。国际尿失禁咨询问卷简表在术后基本保持稳定。使用国际勃起功能指数-5和国际勃起功能指数-15进行的性功能评估显示，患者在术后3个月性功能恶化，但到6个月时仅略有恢复。
腹腔镜手术可实现可行的长期肿瘤学结局，保肛率高，肛门功能中等，失禁评分可接受。虽然尿功能恢复迅速，但性功能恢复较差。
