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).

Autor:	Ito M; Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan., Tsukada Y; Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan., Watanabe J; Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan., Fukunaga Y; Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation of Cancer Research, Tokyo, Japan., Hirano Y; Division of Gastroenterological Surgery, Saitama Medical University International Medical Center, Hidaka, Japan., Sakamoto K; Department of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan., Hamamoto H; Department of General and Gastroenterological Surgery, Osaka Medical and Pharmaceutical University, Osaka, Japan., Yoshimitsu M; Department of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan., Horie H; Department of Surgery, Jichi Medical University, Tochigi, Japan., Matsuhashi N; Department of Gastroenterological Surgery, Pediatric Surgery, Gifu University, Graduate School of Medicine., Kuriu Y; Department of Surgery, Kyoto Prefectural University of Medicine., Nagai S; Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University., Hamada M; Department of Gastrointestinal Surgery Kansai Medical University Hospital., Yoshioka S; Department of Surgery, Yao Municipal Hospital, Osaka, Japan., Ohnuma S; Department of Surgery, Tohoku University Hospital, Sendai, Japan., Hayama T; Department of Surgery, Teikyo University School of Medicine., Otsuka K; Department of Surgery, Iwate Medical University School of Medicine, Shiwa, Iwate, Japan., Inoue Y; Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan., Ueda K; Division of Endoscopic & Colorectal Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan., Toiyama Y; Department of Gastrointestinal and Pediatric Surgery Mie University., Maruyama S; Department of Gastroenterological Surgery, Niitaga Cancer Center Hospital, Niigata, Japan., Yamaguchi S; Division of Colorectal Surgery, Department of Surgery, Tokyo Women's Medical University., Tanaka K; Department of General and Gastroenterological Surgery, Osaka Medical and Pharmaceutical University, Osaka, Japan.; Department of General, Breast and Digestive Surgery, Otsu City Hospital., Suzuki M; Department of Data Science, National Cancer Center Hospital East, Kashiwa, Chiba, Japan., Naitoh T; Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Kanagawa, Japan., Ando K; Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan., Watanabe M; Department of Surgery, Kitasato University Kitasato Institute Hospital, Minato City, Tokyo, Japan.
Jazyk:	angličtina
Zdroj:	Annals of surgery [Ann Surg] 2024 Apr 01. Date of Electronic Publication: 2024 Apr 01.
DOI:	10.1097/SLA.0000000000006290
Abstrakt:	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. Competing Interests: Conflicts of Interest and source of funding: The authors have no conflicts of interest directly relevant to the content of this article. The authors declare that no funding was received in support of this study. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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