Long-term survival and functional outcomes of laparoscopic surgery for clinical stage I ultra-low rectal cancers located within 5 cm of the anal verge: A prospective phase II trial (Ultimate trial)

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; Ultimate Trial Group

doi:10.1097/SLA.0000000000006290

Long-term survival and functional outcomes of laparoscopic surgery for clinical stage I ultra-low rectal cancers located within 5 cm of the anal verge: A prospective phase II trial (Ultimate trial)

Ann Surg. 2024 Apr 1. doi: 10.1097/SLA.0000000000006290. Online ahead of print.

Authors

Masaaki Ito¹, Yuichiro Tsukada¹, Jun Watanabe², Yosuke Fukunaga³, Yasumitsu Hirano⁴, Kazuhiro Sakamoto⁵, Hiroki Hamamoto⁶, Masanori Yoshimitsu⁷, Hisanaga Horie⁸, Nobuhisa Matsuhashi⁹, Yoshiaki Kuriu¹⁰, Shuntaro Nagai¹¹, Madoka Hamada¹², Shinichi Yoshioka¹³, Shinobu Ohnuma¹⁴, Tamuro Hayama¹⁵, Koki Otsuka¹⁶, Yusuke Inoue¹⁷, Kazuki Ueda¹⁸, Yuji Toiyama¹⁹, Satoshi Maruyama²⁰, Shigeki Yamaguchi²¹, Keitaro Tanaka^{6

22}, Motoko Suzuki²³, Takeshi Naitoh²⁴, Koji Ando¹, Masahiko Watanabe²⁵; Ultimate Trial Group

Affiliations

¹ Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan.
² Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.
³ Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation of Cancer Research, Tokyo, Japan.
⁴ Division of Gastroenterological Surgery, Saitama Medical University International Medical Center, Hidaka, Japan.
⁵ Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
⁶ Department of General and Gastroenterological Surgery, Osaka Medical and Pharmaceutical University, Osaka, Japan.
⁷ Department of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan.
⁸ Department of Surgery, Jichi Medical University, Tochigi, Japan.
⁹ Department of Gastroenterological Surgery, Pediatric Surgery, Gifu University, Graduate School of Medicine.
¹⁰ Department of Surgery, Kyoto Prefectural University of Medicine.
¹¹ Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University.
¹² Department of Gastrointestinal Surgery Kansai Medical University Hospital.
¹³ Department of Surgery, Yao Municipal Hospital, Osaka, Japan.
¹⁴ Department of Surgery, Tohoku University Hospital, Sendai, Japan.
¹⁵ Department of Surgery, Teikyo University School of Medicine.
¹⁶ Department of Surgery, Iwate Medical University School of Medicine, Shiwa, Iwate, Japan.
¹⁷ Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
¹⁸ Division of Endoscopic & Colorectal Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
¹⁹ Department of Gastrointestinal and Pediatric Surgery Mie University.
²⁰ Department of Gastroenterological Surgery, Niitaga Cancer Center Hospital, Niigata, Japan.
²¹ Division of Colorectal Surgery, Department of Surgery, Tokyo Women's Medical University.
²² Department of General, Breast and Digestive Surgery, Otsu City Hospital.
²³ Department of Data Science, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
²⁴ Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Kanagawa, Japan.
²⁵ Department of Surgery, Kitasato University Kitasato Institute Hospital, Minato City, Tokyo, Japan.

PMID: 38557445
DOI: 10.1097/SLA.0000000000006290

Abstract

Objective: 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.

Summary background data: Laparoscopic surgery is widely applied for rectal cancer; however, concerns remain, with some studies showing poorer outcomes compared to open surgery.

Methods: 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.

Results: 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.

Conclusions: 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.